Recommendations for practices using gestational carriers: a committee opinion

Recommendations for practices

using gestational carriers:

a committee opinion

Practice Committee of the American Society for Reproductive Medicine and Practice Committee of the

Society for Assisted Reproductive Technology

American Society for Reproductive Medicine, Birmingham, Alabama

This document provides the latest recommendations for the screening, evaluation, and psychoeducational and legal counseling of

gestational carriers and intended parents. It incorporates recent information from the US Centers for Disease Control and Prevention,

US Food and Drug Administration, and American Association of Tissue Banks, with which all programs offering gestational carrier

services must be thoroughly familiar. This document replaces the previous document of the same name, last published in 2017 (Fertil

Steril 2017;107:e4–10). (Fertil Steril

2022;118:65–74. Ó2022 by American Society for Reproductive Medicine.)

El resumen está disponible en Español al ﬁnal del artículo.

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TABLE OF CONTENTS

 Introduction and statement of

purpose

 Care of the intended parents

 Care of the gestational carrier

 Psychoeducational screening and

counseling

 Legal considerations

 Embryo transfer

 Acknowledgments

 References

INTRODUCTION AND

STATEMENT OF PURPOSE

The recommendations in this document

are intended to provide guidance for

appropriate timing to consider the use

of a gestational carrier (GC); provide

recommendations for screening and

testing of intended parents (IPs) or ge-

netic contributors and GCs to reduce

the possibility of complications; and

address the complex medical and psy-

chologic issues that confront the GC

and IPs, as well as the resultant chil-

dren. A GC is deﬁned as a person who

carries a pregnancy resulting from the

transfer of a preimplantation embryo

created by one or more genetic parents

or gamete donors. Genetic contributors

may be the IP(s) and/or gamete donor(s).

A gamete donor is deﬁned as an individ-

ual who donates their gametes for pro-

creation through assisted reproductive

technology (ART) and has no intention

to parent any resulting child(ren). This

guidance incorporates recent informa-

tion on optimal screening and testing

for sexually transmitted infections

(STIs) and psychologic assessments.

The current document represents

an effort to make the screening proced-

ures for individuals involved in third-

party reproduction using a GC more

consistent with and incorporates recent

information from the US Centers for

Disease Control and Prevention (CDC),

US Food and Drug Administration

(FDA), and American Association of

Tissue Banks (AATB). These recommen-

dations use terminology from the fed-

eral agencies in addition to the AATB.

In that context, the term ‘‘ screening’’

refers to specific historical factors that

place an individual at a higher risk of

a given disease, such as human immu-

nodeficiency virus (HIV) and transmis-

sible spongiform encephalopathy, or

Creutzfeldt-Jakob disease. ‘‘Testing’’

refers to specific laboratory studies,

such as serologic tests. The distinction

between screening and testing is

consistent in the article. The term ‘‘ inel-

igible’’ does not mean excluded, but

acceptable with appropriate informed

consent. These recommendations for

the screening and testing of GCs and

genetic parents apply to individuals in

the United States. Because the preva-

lence of STIs and genetic diseases may

vary in other geographic areas, these

recommendations may not be

appropriate for other countries or

individuals who come to the

United States from other countries.

Although the FDA does not require

screening or testing of the GC, the Amer-

ican Society for Reproductive Medicine

(ASRM) recommends testing these indi-

viduals as described in this document.

Other areas where the ASRM rec-

ommendations may be more stringent

than the FDA minimum requirements

are further discussed. Additionally,

state requirements may be more restric-

tive than the FDA, and clinics should be

aware of, and follow, minimum or

required screening and testing require-

ments for their state.

Received April 29, 2022; accepted May 2, 2022.

Correspondence: Practice Committee, ASRM, 1209 Montgomery Hwy, Birmingham, AL 35216 (E-mail:

[email protected]).

Fertility and Sterility® Vol. 118, No. 1, July 2022 0015-0282/$36.00

https://doi.org/10.1016/j.fertnstert.2022.05.001

VOL. 118 NO. 1 / JULY 2022 65

ASRM PAGES

CARE OF IPs

Indications for the Use of a GC

Gestational carriers may be used when a true medical condi-

tion precludes the IP from carrying a pregnancy or would pose

a significant risk of death or harm to the woman or the fetus.

The indication must be clearly documented in the patient’s

medical record. Examples of such medical indications include

the following:

 Absence of uterus (congenital or acquired);

 Significant uterine anomaly (e.g., irreparable Asherman

syndrome; unicornuate uterus associated with recurrent

pregnancy loss);

 Absolute psychologic or medical contraindication to preg-

nancy (e.g., pulmonary hypertension);

 Serious psychologic or medical condition that could be

exacerbated by pregnancy or cause significant risk to the

mother or fetus;

 Biologic inability to conceive or bear a child, such as single

male or homosexual male couple.

Additionally, in the presence of an unidentified endome-

trial factor, such as for patients with multiple unexplained

previous in vitro fertilization failures despite transfer of

good-quality embryos, consideration may be given to the

use of GCs. Further, no owner, operator, laboratory director,

or employee of the practice may serve as a carrier or IP in

that practice.

IPs AND GENETIC CONTRIBUTORS

The US FDA Required Screening and Testing of IPs

and Genetic Contributors

All genetic contributors, including genetic parents and

gamete donors, must be screened in the same manner (1, 2).

The US FDA screening and testing for infectious diseases-

There is no method to completely ensure that infectious

agents will not be transmitted. However, this guidance

(Table 1), including screening for risk factors associated

with infectious diseases; assessing for physical signs of infec-

tious diseases; and testing for infectious diseases should

signiﬁcantly reduce these risks.

 If the sperm or oocyte source is a non-identiﬁed (‘‘ anony-

mous’’) donor, refer to the ASRM Practice Committee docu-

ment titled ‘‘ Guidance Regarding Gamete and Embryo

Donation,’’ last published in 2021 (3, 4).

 If an embryo was created with an initial intent to be used by

sexually intimate partners but is later decided to be trans-

ferred to a GC or a donor embryo recipient, refer to the

ASRM document titled ‘‘ Guidance Regarding Gamete and

Embryo Donation’’ (3).

 Questionnaire—see FDA Medical History Questionnaire(2, 5);

 Physical examination—see FDA Physical Examination (6);

 Laboratory testing—see FDA Laboratory Testing within 7

days of semen production and 30 days before or 7 days af-

ter oocyte acquisition (7).

Prospective genetic contributors with any identified risk

factors based on screening questionnaires, physical examina-

tion, or laboratory testing are considered ineligible for anon-

ymous (non-identiﬁed donor) tissue donation according to

guidelines issued by the FDA. According to current FDA

guidelines, embryos created by such individuals can still be

transferred into a GC provided that the tissue is labeled to

indicate any associated increased risks and that both the IPs

and GC are aware of the theoretical increased risk and have

verbally consented to moving forward with transfer.

Although the FDA does not require that the GC be informed

of the results of the screening, the ASRM strongly recom-

mends that embryos created using gametes from individuals

considered ineligible should only be transferred to a GC

who is adequately informed and counseled regarding the

associated potential risks.

The US FDA eligibility physical examination A physical ex-

amination should be performed to determine whether individ-

uals might be at high risk of HIV, STIs, or other infections that

might be transmissible by using a GC. Prospective egg or

sperm sources should be marked as ‘‘ineligible’’ when speciﬁc

ﬁndings are identiﬁed on the physical examination.

 Guidance for industry: Eligibility determination for donors

of human cells, tissues, and cellular and tissue-based prod-

ucts: https://www.fda.gov/media/73072/download (6);

 Sample donor physical examination form:

https://www.

aatb.org/sites/default/ﬁles/AATB%20Gui dance% 20Do cu

ment%20No.%201%2C%20v2%20%286.27.05%29.pdf (4).

The US FDA eligibility medical questionnaire Complete per-

sonal and sexual history should be obtained to determine

whether individuals might be at high risk of HIV, STIs, or

other infections that might be transmissible via use of a GC.

Prospective egg or sperm sources should be marked as ‘‘ inel-

igible’’ when speciﬁc ﬁndings are identiﬁed on history. For

the complete list of the medical history ﬁndings that

would make a gamete source ineligible, please see the

ASRM Practice Committee document on gamete and em-

bryo donation (3).

The US Food and Drug Administration eligibility laboratory

testing Laboratory requirements for FDA donor eligibility are

outlined in Table 2.

Laboratory testing resources.

 Guidance for industry: Eligibility determination for do-

nors of human cells, tissues, and cellular and tissue-

based products: https://www.fda.gov/media/73072/dow

nload (6);

 Guidance for industry: Donor screening recommendations

to reduce the risk of transmission of Zika virus by human

cells, tissues, and cellular and tissue-based products:

https://www.fda.gov/media/96528/download (4).

Managing laboratory results A positive test should be veri-

ﬁed before notifying the potential genetic parent. If a test is

conﬁrmed positive, the individual should be referred for

appropriate counseling and management.

Individuals with false-positive test results for syphilis us-

ing nontreponemal assays that are confirmed to be negative

using a treponemal-based assay are considered eligible.

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ASRM PAGES

Individuals found to be positive for syphilis, Neisseria

gonorrhoeae,orChlamydia trachomatis should be treated, re-

tested, and deferred from creating embryos for use in a GC for

3 months after documentation that treatment was successful

before being reconsidered. If evidence is presented that treat-

ment occurred more than 3 months ago and was successful,

no further deferral is needed as long as current testing does

not indicate an active infection.

Men who test positive for active cytomegalovirus (CMV)

infection (positive urine or throat culture or paired serum sam-

ples demonstrating a 4-fold rise in immunoglobulin G (IgG)

antibody and immunoglobulin M (IgM) antibody at least 30%

of the IgG level) should be excluded until signs of active infec-

tion are no longer present. Ideally, CMV IgM should be negative

at time of sperm acquisition. There are many strains of CMV,

and superinfection in the GC is possible even if she is CMV

IgG positive. The risk of CMV transmission and newborn

CMV infection from an embryo transfer is extremely low, and

such infants appear to have no significant illness or other

abnormality.

The American Society of Reproductive Medicine

Recommended Testing, Screening, and Procedures

Psychologic counseling The decision to proceed with a GC is

complex, and IPs may beneﬁt from psychologic counseling.

The physician should strongly recommend psychosocial edu-

cation and counseling by a qualified mental health profes-

sional to all IPs. If involved, gamete donors should undergo

psychoeducational evaluation as detailed in the ASRM docu-

ment on gamete and embryo donation (3). The assessment

should include a clinical interview and, where appropriate,

psychologic testing described in Psychoeducational

Counseling.

Genetic screening Any genetic source of oocytes, sperm or

embryos (‘‘ genetic contributors’’ ) should be offered appro-

priate genetic evaluation. Screening for cystic ﬁbrosis, spi-

nal muscular atrophy, and thalassemia or

hemoglobinopathy carrier status should be performed for

all genetic parents (8). Additional expanded carrier

screening may also be appropriate. Panethnic expanded

carrier screening is recommended over ethnicity-based

panels, given the limitations of self-reported ethnicity,

increasing multiethnic populations, and rare recessive con-

ditions that can occur in any ethnic group, despite lower

carrier frequencies. It is important to note that different

panels may test for different conditions; ideally, the

oocyte and sperm sources should be screened for the

same conditions. If carrier screening is performed using

different panels through the same or different laboratories,

ideally a professional should review the results to evaluate

and disclose the reproductive risk to help determine

whether additional screening is warranted.

Medical evaluation The IPs and any genetic contributor(s)

should undergo a complete medical evaluation, including a

thorough history and targeted physical examination, to

ensure that they are healthy enough to proceed with appli-

cable procedures involving ART.

Quarantine of embryos The quarantining of embryos is not

required by the FDA for use in a GC. However, the ASRM rec-

ommends that potential GCs should be offered the option of

cryopreserving and quarantining embryos derived from the

genetic contributors for 35 days, with the release of embryos

only after each genetic contributor has been retested and has

received confirmed negative results.

Record keeping The FDA requires that records pertaining to

each genetic contributor (screening and test results) be

maintained for at least 10 years. However, in the opinion of

the ASRM, a permanent record of each genetic contributor

and each IP(s)’ initial screening, testing, and

subsequent follow-up evaluations should be maintained. To

the extent possible, the clinical outcome for each cycle should

be recorded. A mechanism should exist to maintain such

records as a future medical resource for any offspring

produced.

TABLE 1

Sperm and oocyte US Food and Drug Administration requirements and American Society for Reproductive Medicine recommendations (1–3).

Sperm and oocyte sources and intended parents

FDA requirements ASRM recommendation (in addition to FDA requirements)

Legal consultation and laws may vary by state

Physical examination

Medical questionnaire

Laboratory testing (Table 2)

Sperm source: Infectious laboratory tests at an FDA-approved

laboratory (including CMV IgM and IgG and HTLV-1 and -2 on sperm

source) within 7 days of sperm acquisition.

Oocyte source: Infectious laboratory tests at an FDA-approved laboratory 30

days before, or up to 7 days after, oocyte acquisition.

May use ‘‘ ineligible’’ tissue but must label and consent appropriately

Psychologic counseling

Genetic screening

Medical evaluation

Legal consultation, laws may vary by state

Note: ASRM ¼ American Society for Reproductive Medicine; FDA ¼ US Food and Drug Administration; CMV ¼ cytomegalovirus; HTLV ¼ human T-cell lymphotropic virus; IgG ¼ immunoglobulin G;

IgM ¼ immunoglobulin M.

If the sperm or oocyte source is an unidentiﬁed (previously termed ‘‘ anonymous’’ ) donor, refer to the ASRM bulletin ASRM gamete and embryo donation (6).

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CARE OF GCs

Selection of GCs

The recommended screening and counseling of gestational

carriers is outlined in Table 3.

 Carriers must be of legal age, and preferably between the

ages of 21 and 45 years. Certain situations may dictate

the use of a carrier older than 45 years, but all parties

involved must be informed about the potential risks of

pregnancy with advancing maternal age.

 Ideally, the carrier should have had at least one, term, un-

complicated pregnancy before being considered as a GC for

another couple.

 Ideally, the carrier should not have had more than a total of

five previous deliveries or three deliveries via cesarean

section.

 Carriers must have a stable family environment with

adequate support to help her cope with the added stress

of pregnancy.

Infectious Disease Screening and Testing of a GC

Complete personal and sexual history should be obtained to

identify individuals who might be at high risk of HIV, STIs,

or other acquired infections that might be transmissible to

the fetus. In addition, a physical examination report should

be obtained to determine whether individuals might be at

high risk for HIV, STIs, or other infections that might be trans-

missible to the fetus. The carrier should not be used when any

of the following findings are present:

 Physical evidence for the risk of sexually transmitted dis-

ease, such as genital ulcerative lesions, herpes simplex,

chancroid, and urethral discharge;

 Physical evidence of risk for syphilis or evidence of

syphilis;

 Physical evidence of nonmedical percutaneous drug

use, such as needle tracks; the examination should include

the examination of tattoos, which might obscure needle

tracks;

 Physical evidence of recent tattooing, ear piercing, or body

piercing (within the past 12 months) where sterile tech-

nique was not used.

 Disseminated lymphadenopathy;

 Unexplained oral thrush;

 Blue or purple spots consistent with Kaposi sarcoma;

 Unexplained jaundice, hepatomegaly, or icterus;

 Large scab consistent with recent history of smallpox

immunization;

 Eczema vaccinatum, generalized vesicular rash, severely

necrotic lesion (consistent with vaccinia necrosum), or

corneal scarring (consistent with vaccinial keratitis).

Laboratory Testing

There is no method to completely ensure that the GC will not

have infectious agents that could be transmitted to the fetus.

However, the following guidance, combined with an adequate

medical history and specific exclusion of individuals at high

risk of HIV and other STIs, should dramatically reduce these

risks. Although FDA does not require screening or testing of

GCs for possible transmissible infectious diseases to the fetus,

the ASRM recommends the testing of all GCc and their part-

ners before embryo transfer to protect the health and interests

of all parties involved.

 HIV-1 antibody;

 HIV-2 antibody;

 HIV group O antibody;

 HTLV-1 and HTLV-2 (male partner of GC only);

 Hepatitis C antibody;

 Hepatitis B surface antigen;

 Hepatitis B core antibody (IgG and IgM);

 HIV, HBV, and HCV nucleic acid test;

 Serologic test for syphilis;

 CMV (IgG and IgM) (Male partner of GC only);

 N. gonorrhoeae and C. trachomatis testing using the nucleic

acid test on urine or a cervical or urethral swab using an

FDA-licensed, -approved, or -cleared test labeled for the

detection of these organisms in an asymptomatic, low-

prevalence population.

Before acceptance, the potential GC should undergo a

complete medical evaluation by a qualified medical profes-

sional, including preconception counseling and evaluation

(9). In addition, the medical professional should provide

counseling regarding screening, uterine preparation, embryo

transfer, and hormonal support. A uterine cavity evaluation

by saline-infusion sonogram or another modality is highly

recommended.

Preconception Testing

 Blood type and Rh factor. If there is potential for Rh incom-

patibility, couples should be informed about the obstetric

significance of this condition.

 Cervical cancer screening per guidance from the American

College of Obstetricians and Gynecologists (ACOG);

 Mammogram according to ACOG guidance;

 Titers for varicella and rubella;

 Urine drug screen;

 Clinics should strongly consider requiring vaccination for

GCs against diseases (such as Coronavirus Disease 2019

and other diseases per CDC, ACOG, and ASRM) and advise

IPs to include the requirement of the vaccination of GCs in

their contracts.

Managing Laboratory Results

 A positive test should be confirmed before notifying the in-

dividual. If a test is confirmed positive, the individual

should be referred for appropriate counseling and

management.

 Individuals who test positive for HIV-1, HIV-2, HIV group

O antibody, hepatitis B, or hepatitis C should generally not

be allowed to serve as GCs. Exceptions to this recommenda-

tion require careful counseling, informed consent, and the

documentation of risks in the medical records.

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 Individuals found to be positive for syphilis, N. gonor-

rhoeae or C. trachomatis should be treated, retested, and

deferred from use as a GC until after documentation that

treatment was successful and no longer considered to be in-

fectious before being reconsidered.

 Individuals with false-positive results for syphilis using

non-treponemal assays that are confirmed to be negative

using a treponemal-based assay are eligible to be used as

GCs.

 Women or their partners who test positive for active infec-

tion with CMV (positive urine or throat culture or paired

serum samples demonstrating a 4-fold rise in IgG antibody

and IgM antibody at least 30% of the IgG level) should be

excluded from serving as a carrier until signs of active

infection are no longer present.

Psychosocial evaluation and counseling by a

qualified mental health professional is

recommended for all potential GCs and their

partners (See Psych oeducational Counseling)

Cross-Border GCs The use of a GC in a country remote from

the IPs introduces potential ethical challenges as well as legal

and logistic issues. For detailed discussion of cross-border

reproductive care, refer to the document of the ASRM Ethics

Committee on this topic (10).

PSYCHOEDUCATIONAL COUNSELING

The arrangement between a GC and IPs is a multistep process

that begins with an evaluation of the GC and their partner (if

applicable) and a separate psychoeducational consultation for

IPs, both led by a mental health professional trained to work

in the area of third-party reproduction (11). The ﬁnal step in

this process is a joint session for prospective GCs and IPs,

whether or not they have a pre-existing relationship.

GCs

The psychologic evaluation and counseling of GCs and their

partners is one aspect of the overall selection of a GC. The psy-

chologic evaluation should occur before legal counseling and

the signing of legal contracts with any IP(s). The psychologic

evaluation and implication counseling is the same for directed

and agency recruited GCs.

A psychologic evaluation and implication counseling by

a qualified mental health professional experienced in GC

evaluations is required for all potential GCs and their partner

and/or primary support person or family member. If done by

telehealth, telehealth guidance must be adhered to when

conducting any type of consultation or evaluation remotely

in the guidance that applies to all sections.

Psychologic evaluation The psychologic assessment of a GC

includes a clinical interview, psychologic testing (9), and

implication counseling. An evaluation should be

administered any time a new surrogacy contract is initiated,

and if an evaluation was conducted over a year before the

new contract, a new evaluation should be conducted.

 The purpose and content of the assessment will be

described, and informed consent will be obtained.

 The evaluation includes standardized, empirically validated

testing that is designed for the assessment and/or screening

of mental and behavioral disorders, which should adhere to

the established standards of professional and ethical prac-

tice (12). The examples of assessments include personality

inventories (i.e., Personality Assessment Inventory, Minne-

sota Multiphasic Personality Inventory) (13, 14).

 Collateral contact with other treating mental health profes-

sionals (i.e., psychiatrists, psychotherapists).

 A clinical interview should be conducted and include the

following:

 Social and educational history, including family of

origin;

 Religious or other belief systems that may inﬂuence

behavior;

 Strengths and Resources (e.g., approach to solving

conﬂict and managing stressors).

 Psychiatric or psychologic history, included but not limited

to the following:

 Perinatal mood and anxiety disorders;

 Major depression;

 Signiﬁcant anxiety disorder;

 Bipolar disorder;

 Psychosis;

 Eating disorders;

 Prior hospitalizations, suicide attempts, psychotropic

medication(s), and counseling.

 Social and interpersonal history:

 Current relationships;

 Support of signiﬁcant other (if applicable);

 Social network/support system.

 Occupational history;

TABLE 2

Laboratory tests required for US Food and Drug Administration

eligibility determination.

Chlamydia (NAT)

Gonorrhea (NAT)

Hepatitis B surface antigen

HIV-2 antibody

HIV group O antibody

Hepatitis C antibody

HIV, HBV, HCV NAT

RPR

West Nile virus NAT

HTLV-1 and -2 (sperm only)

CMV IgM and IgG (sperm only)

Note: CMV ¼ cytomegalovirus; HBV ¼ hepatitis B virus; HCV ¼ hepatitis C virus; HIV ¼ hu-

man immunodeﬁciency virus; HTLV ¼ human T-cell lymphotropic virus; IgG ¼ immunoglob-

ulin G; IgM ¼ immunoglobulin M; NAT ¼ nucleic acid test; RPR ¼ rapid plasma reagin test for

syphilis.

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 Flexibility and stability of employment to support the de-

mands of a GC arrangement;

 Sexual history, reproductive trauma, and unresolved nega-

tive reproductive events;

 Substance use history, included but not limited to tobacco,

alcohol, marijuana, recreational drugs, prescription drugs;

 History of physical, emotional, or sexual abuse;

 Current and past legal history including but not limited to

bankruptcy, custody dispute, involvement of local child

welfare services, and termination of parental rights;

 Personality (e.g., maturity, judgment, assertiveness, and

empathy);

 Current major life stressors or anticipated life changes;

 GC experience:

 Previous GC experience or application to another fa-

cility or rejection from another facility;

 Motivation to become a GC;

 Discussion of the identities of all parties and the ways

in which these might impact the arrangement. These

may include race, ethnicity, religion, and socioeco-

nomic status;

 Ideas on attachment and ability to detach from a

pregnancy;

 Desire for more children of her own;

 How GC compensation will be used.

 Assess for coercion including but not limited to the

following:

 Financial including primary source of income and

government assistance programs;

 Personal;

 Familial;

 Dual relationships (e.g., employee/employer).

 Mental status evaluation.

Additionally, directed GC arrangements should also

consider the following while assessing appropriateness of a

speciﬁc match:

 Stability of current/past relationship;

 Impact on overlapping social networks;

 Potential for negative outcome to impact relationship;

 History of successful conﬂict management.

Implication counseling Gestational carriers and their part-

ners or support person both need to participate in implication

counseling that explores the following:

Treatment plan

 Discuss their understanding of the medical protocol,

including source of gametes, sexual abstinence, sched-

uling demands, risks of cancelled cycles or unsuccessful

cycles, number of embryos transferred, multiple preg-

nancy, multifetal pregnancy reduction, prenatal diag-

nostic testing, and elective termination;

 Provide psychoeducation on ASRM and Society for Assis-

ted Reproductive Technology (SART) guidance related to

single embryo transfer (SET) (15);

 Discuss attitudes toward prenatal diagnostic testing, multi-

fetal pregnancy reduction, pregnancy loss, and the termi-

nation of pregnancy;

 Informing the GC about her right to make choices for her

body;

 Elucidate concerns about the potential complications of

pregnancy and the potential loss of own fertility.

Psychosocial impact of pregnancy

 Ability to separate from and relinquish the child and antic-

ipated future feelings toward them;

 Risks of both GC and her family’s attachment to the child;

 The impact of the pregnancy on relationship dynamics

(e.g., family, friends, faith communities, workplace).

Lifestyle choices Expectations of the GC regarding travel,

exercise, diet, sexual activity, alcohol, tobacco use, etc.

should be discussed

Relationship with IP(s) Expectations and management of

present, and future relationship between GC and her family

with the IP(s) and their children

Hospital preferences

 Comfort level with IP(s) in delivery room;

 Openness to baby caretaking/interaction after delivery;

 Preferences regarding breast milk.

Criteria for rejection of a GC candidate

 Inadequate cognitive functioning to support informed

consent;

 Evidence of financial or emotional coercion;

 Abnormal psychologic evaluation or testing results as

determined by the qualiﬁed mental health professional;

 Unresolved or untreated alcohol and/or drug abuse or

addiction, child abuse, sexual abuse, physical abuse,

depression, anxiety, eating disorders, or traumatic preg-

nancy, labor and/or delivery;

 Current use of psychoactive medication;

 History of major depression, postpartum mood disorder, bi-

polar disorder, psychosis, or a clinically signiﬁcant anxiety

disorder with impaired functioning;

 Interpersonal or environmental instability, for example:

 Current marital or relationship instability;

 Insufﬁcient emotional support from partner/ spouse or

support system;

TABLE 3

Screening and counseling of gestational carriers.

Medical evaluation and counseling

Infectious disease screening and testing

Medical history (questionnaire)

Physical examination

Laboratory testing

Psychosocial evaluation and counseling

Preconception testing

Uterine cavity evaluation

Legal counseling

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 Chaotic lifestyle, current major life stressor(s).

 Inability to maintain respectful and caring relationship

with others;

 Evidence of an inability to emotionally separate from/sur-

render the child at birth;

 Failure to exhibit altruistic commitment to become a GC;

 Excessively stressful family demands;

 History of conﬂict with authority;

 Inability to perceive and understand the perspective of

others;

 Motivation to use compensation to solve own infertility;

 Unresolved issues with a negative reproductive event.

IPs

The decision to use a GC is complex, and patients and their

partners (if applicable) will benefit from psychosocial educa-

tion to aid in this decision. The physician must require psy-

chosocial education and counseling by a qualified mental

health professional (11) trained in GC evaluation and psycho-

education to all IPs.

Psychoeducational consultation for IPs

 A clinical interview that should explore the IP(s)’ history of

infertility or family building efforts as well as coping stra-

tegies for these challenges;

 The potential impact of the relationship between the IP and

GC and future contact;

 Discussion of the identities of all parties and the ways in

which these might impact the arrangement. These may

include race, ethnicity, religion, and socioeconomic status;

 Exploring with IPs about significant psychologic issues that

could compromise successful collaboration with the GC;

 Discussion about use of donor gametes in creating the

embryo(s);

 Expectations related to privacy and disclosure to friends

and family including use of social media;

 Exploring with the IP(s) the potential for communication

challenges, degree and locus of control issues, as well as

other emotional risks, e.g., grief, guilt, jealousy, and con-

cerns, regarding bonding that may be associated with the

GC process;

 Discussion of the medical protocol, scheduling demands, risks

of cancelled cycles or unsuccessful cycles, number of embryos

transferred, multiple pregnancy, multifetal pregnancy reduc-

tion, prenatal diagnostic testing, and elective termination;

 Requirement of IP(s) alignment with the GC regarding med-

ical decision-making;

 Meeting the emotional and psychosocial needs of the GC

and her family;

 Expectations about the GC’s behavior during pregnancy

and methods for resolving conﬂicts (e.g., eating habits, pre-

scription drugs, alcohol);

 Expectations of disclosure of the GC’s role to any born chil-

d(ren) and scope of relationship between GC, IP(s), and chil-

dren after birth;

 Disposition of extra embryos;

 Need for separate legal consultation and a written contract.

Criteria for rejection of IPs

 Inability to maintain respectful and caring relationship

with GC;

 Current or previous perpetrators of sexual or physical abuse

or involvement of local child welfare services and termina-

tion of parental rights;

 Gross marital or relationship instability;

 Intended parents’ failure to follow ASRM guidance on

number of embryos transferred and inability to agree

with GC’s decision on number of embryos transferred, se-

lective reduction, and pregnancy termination;

 Ongoing legal disputes;

 History of noncompliance or ongoing problem-atic inter-

actions with program or medical staff;

 Intended parents’ reproductive plan is to pursue concurrent

pregnancies by embryo transfers to more than 1 GC or by

seeking concurrent pregnancies for a GC and an IP.

Joint Session for GC and Partner (If Applicable)

With IP(s)

The physician should require a joint session led by a mental

health professional knowledgeable about these arrangements

and appropriately trained to review the topics outlined below.

The joint session is a meeting with the prospective GC, and

their partner, and IP(s) with the mental health professional;

this meeting is held to ensure that everyone begins the treat-

ment phase aligned in their expectations of each other and the

process.

Joint session topics The joint session topics include, but are

not limited to, the following:

 An agreement on the expected timeline of treatment;

 Understanding of the medical procedures involved;

 Discussion of number of embryos to be transferred and

number of cycles planned in their contract;

 Discussion of each party’s feelings about prenatal testing,

multifetal pregnancy reduction and termination of a preg-

nancy to determine whether all are in agreement as to how

they would proceed in the event decisions about these is-

sues arose during their treatment or the pregnancy;

 Expectations for how the IPs would like to participate in the

pregnancy and delivery;

 Expectations for communication between the IPs and the

GC, including frequency and preferred format;

 Strategies for managing and resolving conﬂicts that may

arise during the pregnancy;

 Discussion of the identities of all parties and the ways in

which these might impact the arrangement. These may

include race, ethnicity, religion, and socioeconomic status;

 Expectations for the GC’s behaviors following the transfer

and during the pregnancy (e.g., diet, exercise, travel, social

media, vaccinations);

 Discussion of expectations for behaviors that may be

affected by current medical events (e.g., Coronavirus Dis-

ease 2019, traveling, vaccination, Zika);

 Discussion about the IPs’ interest in receiving breast milk

from the GC after the birth and whether the GC is willing

to attempt pumping after the birth;

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Fertility and Sterility®

 Expectations for how each party envisions their relation-

ship after their GC arrangement has ended.

Criteria for rejection of the arrangement between the GC

and IP(s)

 Gestational carrier’s unavailability for the IP(s)’ preferred

timeline for treatment (e.g., due to schedule conﬂicts,

travel);

 Disagreement on the plan for medical treatment (e.g., num-

ber of embryos transferred);

 Any evidence of discordance in how decisions would be

made during the present GC arrangement in regard to

prenatal testing, multifetal reduction, induction of labor,

cesarean section, or termination of a pregnancy;

 Evidence of incompatibility in communication preferences;

 Disagreement between the GC and IPs on expectations

for behaviors following the transfer and during the preg-

nancy (e.g., diet, exercise, travel, social media,

vaccinations);

 Disagreement between the GC and IPs regarding the GC’s

behaviors in response to a medical event during the GC

arrangement;

 Divergent expectations about the relationship between the

parties both during and following the GC arrangement;

 Special consideration should be given to matches where a

pre-existing relationship exists, that participating as a GC

is voluntary, without evidence of coercion, and will do no

harm to the current relationship.

LEGAL COUNSELING AND CONSIDERATIONS

Laws relevant to GC arrangements vary from state to state

and may also change, as to both legal parentage and

conduct of the participants. It is imperative that each partic-

ipant or participant couple, meaning the GC with any

spouse, and any single IP or partnered IPs in a GC arrange-

ment, have independent legal counsel who is licensed in the

applicable state, to represent, advise, and assist them before

entering into a GC agreement and in executing a legal

agreement. The legal counsel should remain available to

represent, advise, and assist them throughout the GC

arrangement. Before initiation of any treatment, a fully

executed legal agreement, a clearance letter attesting to

the completion of a legal agreement, and all informed con-

sent documents, including a medical release that authorizes

the ART practitioner to share with all participants otherwise

privileged medical information pertinent to the GC arrange-

ment, should be in place.

The central issues legal agreements should address:

establishment of legal parentage and non-parentage;

conduct of the parties; expectations and decision-making

as to prenatal testing, pregnancy management, and deliv-

ery; coverage for medical expenses; ﬁnancial arrangements

for agreed on fees and expenses; allocation of risk(s) and

responsibility, and escrow arrangements. Although mutual

understandings as to selective reduction and/or termination

should be addressed, no agreement should contradict

constitutionally protected reproductive decision-making

by a GC as to prenatal and pregnancy decision-making.

Experienced ART legal counsel is strongly recommended

as GC arrangements involve a novel area of the law with

many state law nuances and potential overlap or conﬂicts

with other jurisdictions as well as other potential areas of

the law. Before medical treatment, and no later than the

initiation of an in vitro fertilization cycle, legal counsel

for the parties should present the ART practitioner with a

legal clearance letter attesting to the completion and

execution of a contract between the participants with inde-

pendent legal counsel, and the relevant information for the

treating physician such as the maximum number of em-

bryos to transfer, maximum number of transfer attempts

agreed to, and any time limits for those procedures or the

arrangement.

Protection of Confidentiality

Individuals participating in GC programs should be assured

that their confidentiality and medical information will be pro-

tected insofar as federal and local laws and regulations

permit. Medical records detailing the eligibility of the IPs

and GC should be maintained as stipulated by federal and

local requirements.

EMBRYO TRANSFER

Single embryo transfer is strongly recommended in all GC cy-

cles, given the health risks associated with multiple gestations

for the GC (15). The ASRM recommends that at a minimum,

age-related limits on the number of embryos to transfer

should be followed. However, this could result in the transfer

of multiple embryos to a GC when the provider of the oocyte is

38 years of age or older. In cycles for which the provider of the

oocyte is 38 years or older, selection techniques such as pre-

implantation genetic testing for aneuploidy, may be consid-

ered. Testing and subsequent elective, single, euploid

embryo transfer may result in a higher likelihood of implan-

tation and a lower chance of multiple gestations (13). This

may obviate the temptation for multiple embryo transfers

when the oocyte source is of an older age.

Acknowledgments: This report was developed under the

direction of the Practice Committee of the American Society

for Reproductive Medicine as a service to its members and

other practicing clinicians. Although this document reﬂects

appropriate management of a problem encountered in the

practice of reproductive medicine, it is not intended to be

the only approved standard of practice or to dictate an exclu-

sive course of treatment. Other plans of management may be

appropriate, taking into account the needs of the individual

patient, available resources, and institutional or clinical prac-

tice limitations. The Practice Committee and the Board of Di-

rectors of the American Society for Reproductive Medicine

have approved this report. This document was reviewed by

ASRM members and their input was considered in the prepa-

ration of the ﬁnal document. The following members of the

ASRM Practice Committee participated in the development

of this document: Alan Penzias, M.D.; Kristin Bendikson,

72 VOL. 118 NO. 1 / JULY 2022

ASRM PAGES

M.D.; Marcelle Cedars, M.D.; Tommaso Falcone, M.D.; Karl

Hansen, M.D., Ph.D.; Micah Hill, D.O.; Sangita Jindal, Ph.D.;

Suleena Kalra, M.D., MSCE; Jennifer Mersereau, M.D.; Robert

Rebar, M.D.; Richard Reindollar, M.D.; Anne Steiner, M.D.,

M.P.H.: Cigdem Tanrikut, M.D.; and Belinda Yauger, M.D.

The Practice Committee acknowledges the special contribu-

tion of Anne Steiner, M.D., M.P.H.; Paula Amato, M.D.; Susan

Crockin, J.D.; and Jennifer Kawwass, M.D.; along with the

Mental Health Professional Group Document Working Group

in the preparation of this document. All Committee members

disclosed commercial and ﬁnancial relationships with manu-

facturers or distributors of goods or services used to treat pa-

tients. Members of the Committee who were found to have

conﬂicts of interest based on the relationships disclosed did

not participate in the discussion or development of this docu-

ment.

DIALOG: You can discuss this article with its authors and

other readers at https://www.fertstertdialog.com/posts/

35212

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Fertility and Sterility®

Recomendaciones para pr



acticas que utilizan gestantes subrogadas: una opini



on del comit



Este documento ofrece las



ultimas recomendaciones para el cribado, evaluaci



on, y asesoramiento legal y psicoeducacional de ges-

tantes subrogadas y futuros padres. Incorpora la informaci



on reciente del centro americano para el control y prevenci



on de enfer-

medades infecciosas, la administraci



on americana de alimentos y medicamentos, y la asociaci



on americana de bancos de tejidos,

con lo que todos los programas que ofrecen servicios de gestantes subrogadas deben estar totalmente familiarizados. Este docu-

mento reemplaza al previo con el mismo nombre publicado en 2017.

74 VOL. 118 NO. 1 / JULY 2022

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