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Guidance on the limits to the number of embryos to transfer: a committee opinion (2021)


On the basis of American Society for Reproductive Medicine and Society for Assisted Reproductive Technology data, the American Society for Reproductive Medicine's guidelines for the limits on the number of embryos to be transferred during in vitro fertilization cycles have been further refined in continuing efforts to promote singleton gestation and reduce the number of multiple pregnancies.

BACKGROUND 

The American Society for Reproductive Medicine’s (formerly The American Fertility Society) guidance for the limits to the number of embryos to be transferred during in vitro fertilization (IVF) cycles aims to promote singleton gestation and reduce the number of multiple pregnancies while maximizing the cumulative live birth rates. Although the incidence of high-order multiple pregnancies (three or more fetuses in one pregnancy) have diminished in recent years, twin gestations are still a relatively common occurrence with assisted reproductive technology (ART). Multiple gestation leads to an increased risk of complications in both the woman carrying the pregnancy and the fetuses (1–3). Even twin gestations have significant additional morbidity compared with that of singletons (3). Ideally, the goal of ART is to achieve a healthy singleton gestation (4–6). Among cycles reported to the Society for Assisted Reproductive Technology (SART) in 2017, 12.4% of women <38 years of age who had a successful IVF cycle had a twin gestation (7), down from 23% in 2014 but still significantly more than baseline. Almost half of all ART multiple gestations in the United States occurred in women <35 years old when 2 fresh or frozen blastocysts were transferred (8). 
 
Respect for a patient's autonomy to consider placement of more than one embryo requires a full discussion of the ethical and medical considerations, ensuring that a patient is able to make a fully informed decision. Elective placement of multiple embryos is often influenced by financial considerations. Studies showed that insurance coverage for IVF was associated with the transfer of fewer embryos and with significantly lower rates of high-order multiple births (9). Financial pressures may be a coercive tipping point in favor of multiple embryo transfer. In contrast, if patients are informed of the risks inherent in twin or high-order pregnancy and these financial pressures are removed or at least alleviated, most patients would opt to maximize their chance of a singleton, safe pregnancy and birth (10). 
 
Although multifetal pregnancy reduction can be performed to reduce the fetal number, the procedure may result in the loss of all fetuses, it does not completely eliminate the risks associated with multiple pregnancies, and it may have adverse psychological consequences (11). Moreover, multifetal pregnancy reduction is not an acceptable option for many women.  

RECOMMENDATIONS 

In an effort to promote singleton gestations, reduce twin gestations, and eliminate high-order multiple gestations, the American Society for Reproductive Medicine and SART have developed the following guidance to assist ART programs and patients in determining the appropriate number of cleavage-stage embryos or blastocysts to transfer. National data from 2013 demonstrated  that  clinics  that performed higher rates of elective single-embryo transfer in women aged <38 years had decreased rates of multiple gestations with no significant impact on clinic-level live birth rates (12). In addition, preimplantation genetic testing for aneuploidy maybe a tool to reduce the rate of multiple gestations, especially in women >37 years of age. In women %42 years, transferring a single euploid blastocyst resulted in pregnancy rates similar to those of transferring 2 untested blastocysts while dramatically reducing the risk of twins (13). Strict limitations on the number of embryos transferred, which may be required by law in some countries, do not allow treatment plans to be individualized after careful consideration of each patient's own unique circumstances. Therefore, on rare occasions, transferring more or fewer embryos than recommended by this document may be justified; documentation of justification for transferring a greater number of embryos should be recorded in the medical record, noting the individual clinical conditions, including patient age, parity, medical conditions, embryo quality, the opportunity for cryopreservation, and the patient prognosis. 
 
Individual programs are encouraged to generate and use their own data regarding patient characteristics and the number of embryos to be transferred with the goal of maintaining pregnancy rates and minimizing multiple gestations. For example, if a program notes a particularly high implantation rate for cleavage-stage embryos among their patients aged 41–42 years, they should adjust their clinic-specific range for the number of embryos to transfer downward. Accordingly, programs should monitor their results continually and consider decreasing the number of embryos transferred to minimize undesirable outcomes. Conversely, use of a clinic's own data cannot be used to routinely exceed the recommended limits. Programs that have a multiple pregnancy rate that is well above average for all SART-reporting clinics may be audited by SART, and persistent noncompliance may result in expulsion from SART. 
 
Apart from young age, characteristics like the expectation of one or more high-quality embryos available for cryopreservation; euploid embryos; and previous live birth after an IVF cycle have been associated with a favorable prognosis for pregnancy. Additional favorable criteria for frozen embryo transfer (FET) cycles include the availability of vitrified, high-quality blastocysts for transfer (14). The number of embryos transferred should be determined by the physician and the patient(s), informed consents completed, and the information recorded in the clinical record. In the absence of data generated by the individual program, and on the basis of data generated by all clinics providing ART services, the following guidelines are recommended for upper limits (Table 1):

Table 1


Recommendations for the limit to the number of embryos to transfer
                                                                            Age
Prognosis <35 35-37 38-40 41-42
Cleavage stage embryos
Euploid (a) 1 1 1 1
Other Favorable (b) 1 1 ≤3 ≤4
Embryos not Euploid (a) or Favorable (b) ≤2 ≤3 ≤4 ≤5
Blastocysts
Euploiad (a) 1 1 1 1
Other Favorable (b) 1 1 ≤2 ≤3
Embryos not Euploid (a) or Favorable (b) ≤2 ≤2 ≤3 ≤3
(a) Demonstrated euploid embryos, best prognosis
(b) Other Favorable = Any ONE of these criteria: Fresh cycle: expectation of 1 or more high-quality embryos available for cryopreservation or previous live birth after a prior transfer with sibling embryo(s); FET cycle: availability of vitrified day-5 or day-6 blastocysts, euploid embryos, 1st FET cycle, or previous live birth after an IVF cycle.

**Please note that justification for transferring additional embryos beyond recommended limits should be clearly documented in the patient’s medical record.
  1. Patients with a favorable prognosis:
    1. Transfer of a euploid embryo should be limited to one, regardless of patient age.
    2. Patients <35 years of age should be strongly encouraged to receive a single-embryo transfer, regardless of the embryo stage.
    3. For patients between 35 and 37 years of age, strong consideration should be made for a single-embryo transfer.
    4. For patients between 38 and 40 years of age, no more than 3 untested cleavage-stage embryos or 2 blastocysts should be transferred.
    5. Patients 41–42 years of age should plan to receive no more than 4 untested cleavage-stage embryos or 3 blastocysts.
  2. Other scenarios:
    1. In each of the preceding age groups, patients who do not meet the criteria for a favorable prognosis may have an additional embryo transferred according to their individual circumstances (Table 1). The patient must be counseled regarding the additional risk of twin or higher-order multiple pregnancy.
    2. If otherwise favorable patients fail to conceive after multiple cycles with high-quality embryo(s) transferred, the physicians and patients may consider proceeding with an additional embryo to be transferred.
    3. Patients with a coexisting medical condition for which a multiple pregnancy may increase the risk of significant morbidity should not have more than one embryo transferred.
    4. In the rare cases in which the number of embryos or blastocysts transferred exceeds the recommended limits, both the counseling and the justification must be documented in the patient's permanent medical record.
    5. In women R43 years of age, there are insufficient data to recommend a limit on the number of embryos to transfer when the patient uses her own oocytes. Caution should be exercised as the risk associated with multiple pregnancy increases dramatically with advancing maternal age.
  3. In donor-oocyte cycles, the age of the donor should be used to determine the appropriate number of embryos to transfer. For example, when the donor is <38 years of age and other favorable criteria exist, single-embryo transfer should be planned.
  4. Single-embryo transfer should be strongly recommended in all gestational carrier (GC) cycles, given the health risks associated with multiple gestations for the GC. At a minimum, it is recommended to follow age-related limits on the number of embryos to transfer in GC cycles, on the basis of the age of the woman who produced the oocytes (either the intended parent or oocyte donor).
  5. In FET cycles, favorable characteristics should be on the basis of the age of the woman when the embryos were  cryopreserved and include the presence of high-quality vitrified embryos, euploid embryos, first FET cycle, or previous live birth after a prior transfer with sibling embryo(s). Embryo transfer numbers should not exceed the  recommended limit on the number of fresh embryos transferred for each age group.

Acknowledgments: This report was developed under the direction of the Practice Committees of the American Society for Reproductive Medicine (ASRM) and the Society for Assisted Reproductive Technology (SART) 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 exclusive 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 practice limitations. The Practice Committees and the Boards of Directors of the ASRM and SART have approved this report.

This document was reviewed by ASRM members and their input was considered in the preparation of the final document. The following members of the ASRM Practice Committee participated in the development of this document: Alan Penzias, M.D.; Ricardo Azziz, M.D., M.P.H., M.B.A.; Kristin Bendikson, M.D.; Marcelle I. Cedars, MD; Tommaso Falcone, M.D.; Karl Hansen, M.D., Ph.D.; Micah Hill, D.O.; Sangita Jindal, Ph.D.; Suleena Kalra, M.D., M.S.C.E.; Jennifer Mersereau, M.D.; Richard Reindollar, M.D.; Chevis N. Shannon, Dr.P.H., M.P.H., M.B.A.; Anne Steiner, M.D., M.P.H.: Cigdem Tanrikut, M.D.; Hugh Taylor, M.D.; and Belinda Yauger, M.D. All Committee members disclosed commercial and financial relationships with manufacturers or distributors of goods or services used to treat patients. Members of the Committees who were found to have conflicts of interest on the basis of the relationships disclosed did not participate in the discussion or development of this document. 


REFERENCES 

  1. Rao A, Sairam S, Shehata H. Obstetric complications of twin pregnancies. Best Pract Res Clin Obstet Gynaecol 2004;18:557–76. 
  2. The ESHRE Capri workshop group. Multiple gestation pregnancy. Hum Reprod 2000;15:1856–64. 
  3. Santana DS, Cecatti JG, Surita FG, Silveira C, Costa ML, Souza JP, et al. Twin pregnancy and severe maternal outcomes: the World Health Organization multicountry survey on maternal and newborn health. Obstet Gynecol 2016;127:631–41. 
  4. Practice Committee of the American Society for Reproductive Medicine. Multiple gestation associated with infertility therapy: an American Society for Reproductive Medicine Practice Committee opinion. Fertil Steril 2012; 97:825–34. 
  5. Practice Committee of Society for Assisted Reproductive Technology, Practice Committee of the American Society for Reproductive Medicine. Elective single-embryo transfer. Fertil Steril 2012;97:835–42. 
  6. ESHRE Guideline Group on Good Practice in IVF Labs, De los Santos MJ, Apter S, Coticchio G, Debrock S, Lundin K, Plancha CE, et al. Revised guidelines for good practice in IVF laboratories (2015). Hum Reprod 2016;31: 685–6. 
  7. Society for Assisted Reproductive Technology. National summary report. Available at: https://www.sartcorsonline.com/rptCSR_PublicMultYear. aspx?reportingYear¼2019. Accessed June 18, 2021. 
  8. Kissin DM, Kulkarni AD, Mneimneh A, Warner L, Boulet SL, Crawford S, et al. Embryo transfer practices and multiple births resulting from assisted reproductive technology: an opportunity for prevention. Fertil Steril 2015; 103:954–61. 
  9. Jain T, Harlow BL, Hornstein MD. Insurance coverage and outcomes of in vitro fertilization. N Engl J Med 2002;347:661–6. 
  10. Johnston J, Gusmano MK, Patrizio P. In search of real autonomy for fertility patients. Health Econ Policy Law 2015;10:243–50. 
  11. Stone J, Eddleman K, Lynch L, Berkowitz RL. A single center experience with 1000 consecutive cases of multifetal pregnancy reduction. Am J Obstet Gynecol 2002;187:1163–7. 
  12. Mancuso AC, Boulet SL, Duran E, Munch E, Kissin DM, Van Voorhis BJ. Elective single embryo transfer in women less than age 38 years reduces multiple birth rates, but not live birth rates, in United States fertility clinics. Fertil Steril 2016;106:1107–14. 
  13. Forman EJ, Hong KH, Ferry KM, Tao X, Taylor D, Levy B, et al. In vitro fertilization with single euploid blastocyst transfer: a randomized controlled trial. Fertil Steril 2013;100:100–7.e1. 
  14. Richter KS, Ginsburg DK, Shipley SK, Lim J, Tucker MJ, Graham JR, et al. Factors associated with birth outcomes from cryopreserved blastocysts: experience from 4,597 autologous transfers of 7,597 cryopreserved blastocysts. Fertil Steril 2016;106:354–62.e2. 

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Recommended practices for the management of embryology, andrology, and endocrinology laboratories: a committee opinion (2014)

A general overview for good management practices within the endocrinology, andrology, and embryology laboratories in the United States. View the Recommendation
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Best practices of ASRM and ESHRE: a journey through reproductive medicine (2012)

ASRM and ESHRE are the two largest societies in the world whose members comprise the major experts and professionals working in reproductive medicine. View the Committee Joint Guideline

Topic Resources

View more on the topic of in vitro fertilization (IVF)
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ASRM Responds to Proposed Alabama Legislation

We are proud of our Alabama members and their patients, who have been such incredible advocates working to motivate their legislators to protect IVF.

View the Press Release
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Senate Budget Hearing is Well Timed Following Alabama IVF Ruling

ASRM statement regarding the Senate Budget Committee’s hearing entitled: No Rights to Speak of: The Economic Harms of Restricting Reproductive Freedom.

View the Press Release
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ASRM Responds to Senate’s Failure to Pass Access to Family Building Act

We are disappointed by the Senate’s failure to meet the moment and pass federal legislation protecting access to in vitro fertilization (IVF).

View the Press Release
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Alabama Supreme Court Rules Frozen Embryos are “Unborn Children” and admonishes IVF’s “Wild West” treatment

Legally Speaking™ on presenting facts and reflecting on the impact and potential implications of  legal developments in ART. View the Column
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ASRM Condemns Profoundly Misguided and Dangerous Court Decision in Alabama

In LePage v Mobile Infirmary Clinic, the Alabama Supreme Court made a decision that flies in the face of medical reality and the needs of the citizens.

View the Press Release
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Fertility and Sterility On Air - TOC: February 2024

Topics this month include the optimial AMH level in oocyte donors, the role of mean number of DNA breakpoints (MDB) in sperm DNA integrity, and more. Listen to the Episode
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Fertility and Sterility On Air - Unplugged: January 2024

Topics this month include: HCG as a predictor of pregnancy outcome after IVF, progestin ovulation suppression and embryo development, and more. Listen to the Episode
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ASRM applauds introduction of Access to Family Building Act of 2024

ASRM is thrilled by the introduction of the Access to Family Building Act 

View the Press Release
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Billing IVF lab work

We typically bill our IVF Lab work under the rendering provider who performs the VOR. Who should be the supervising provider for embryology billing? View the Answer

Fertility and Sterility On Air - Unplugged: September 2023

Topics this month include: IVF outcomes for patients with HIV, using sperm methylation patterns to determine IUI and IVF success, and more Listen to the Episode
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Fertility and Sterility On Air - Unplugged: August 2023

Topics this month include: medications that impair male fertility, IVF after gender-affirming hormonal therapy in a mouse model, and more. Listen to the Episode
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Journal Club Global: IVM in Clinical Practice: An Idea Whose Time Has Come?

In vitro maturation (IVM) has the potential to make IVF cheaper, safer, and more widely accessible to patients with infertility. View the Video
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Comparison of pregnancy rates for poor responders using IVF with mild ovarian stimulation versus conventional IVF: a guideline (2018)

Mild-stimulation protocols with in vitro fertilization (IVF) generally aim to use less medication than conventional IVF. View the Guideline
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IVF cycle management and facility fees, an overview

How should IVF Cycle Management be coded?  View the Answer
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Limited ultrasound performed by RN

Would it be appropriate to bill a 99211 when an RN is doing a limited ultrasound and documenting findings during an IUI or IVF treatment cycle? View the Answer
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CPT 89253 and 89254 for Assisted hatching

Can I bill CPT codes 89253 and 89254 together? If yes, do I need a modifier on any of the codes? View the Answer
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Journal Club Global - What is the optimal number of oocytes to reach a live-birth following IVF?

The optimal number of oocytes necessary to expect a live birth following in vitro fertilization remains unclear. View the Video
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Patient Education

What is the correct way to bill for the patient education sessions performed by registered nurses to individual patients prior to their IVF cycle? View the Answer
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Pregnancy Ultrasound

Our practice does routine ultrasounds (sac check- 76817) at the end of an IVF cycle and bill with a diagnosis code O09.081, pregnancy resulting from ART.  View the Answer
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IUI or IVF

Should other ovarian dysfunction (diagnosis code E28.8) or unspecified ovarian dysfunction (diagnosis code E28.9) can be used for an IUI or an IVF cycle View the Answer
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IVF Case Rates

What ICD-10 codes apply to case rates? View the Answer
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IVF Consent Counseling

When a patient is scheduled to undergo IVF and the provider schedules the patient for a 30-minute consultation is this visit billable? View the Answer
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Ovulation Induction Monitoring for IUI

We would like to clarify the correct ICD 10 diagnosis code for monitoring of an IUI cycle.  View the Answer
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In Vitro Maturation

Have CPT codes been established for maturation in vitro? View the Answer
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IVF Billing Forms

I am seeking information on IVF insurance billing guidelines.  View the Answer
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IVF Billing Globally

Am I correct in assuming that it is duplicate billing for both the ambulatory center and embryology laboratory to bill globally? View the Answer
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IVF Billing of Professional Charges

Are we allowed to bill professional charges under the physician for the embryologist who performs the IVF laboratory services? View the Answer
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Lab Case Rates

What ICD-10 codes apply to case rates? View the Answer
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Oocyte Denudation

Is there is a separate code for denudation of oocytes?  View the Answer
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IV Fluids During Egg Retrieval

Is it appropriate to bill the insurance company for CPT 96360, Under Hydration Infusion when being used in conjunction with IVF retrieval? View the Answer
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Endometrial Biopsy/Scratch

What CPT code should be used for a “scratch test”?  View the Answer
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Endometriosis and Infertility

For treatment like IVF would we bill with N97.x first or an endometriosis diagnosis? View the Answer
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Follicle Monitoring For Diminished Ovarian Reserve

If a patient has decreased ovarian reserve (ICD-10 E28.8) and patient is undergoing follicle tracking to undergo either an IUI cycle or IVF cycle... View the Answer
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Global Billing Vs Billing Under Provider

For an IVF cycle (that is not being billed global to an insurance plan) is it appropriate to bill the charges under one “global” provider? View the Answer
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Diagnosis of Infertility for IVF Procedure

How important is it to have accurate documentation of the type of infertility diagnosis for IVF procedures?  View the Answer
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Egg Culture and Fertilization

We are billing for the technical component of 89250 and would like to also bill a professional component of the 89250. View the Answer
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Egg Culture and Fertilization: Same Gender

A same-sex male couple requested half their donor eggs be fertilized with sperm from male #1 and the other half fertilized from male #2. View the Answer
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Donor Embryos

Could you give guidance for the correct ICD-10 code(s) to use when a patient is doing an Anonymous Donor Embryo Transfer cycle? View the Answer
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Journal Club Global: Natural versus Programmed FET Cycles

A significant portion of IVF cycles now utilize frozen embryo transfer.
View the Video
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Role of assisted hatching in in vitro fertilization: a guideline (2022)

There is moderate evidence that assisted hatching does not significantly improve live birth rates in fresh assisted reproductive technology cycles View the Committee Opinion
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Journal Club Global - Best Practices of High Performing ART Clinics

This Fertility and Sterility Journal Club Global discusses February’s seminal article, “Common practices among consistently high-performing in vitro fertilization programs in the United States: a 10 year update.” View the Video
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Journal Club Global Live from India - Adjuvants in IVF and IVF Add-Ons for the Endometrium

Many adjuvants have been utilized by IVF centers to improve their success rates. View the Video
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Evidence-based outcomes after oocyte cryopreservation for donor oocyte in vitro fertilization and planned oocyte cryopreservation: a guideline (2021)

A review of success rates, factors that may impact success rates, and  outcomes. View the Committee Opinion
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Development of an emergency plan for in vitro fertilization programs: a committee opinion (2021)

All IVF programs and clinics should have a plan to protect fresh and cryopreserved human specimens (embryos, oocytes, sperm). View the Committee Opinion
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In vitro maturation: a committee opinion (2021)

The results of in vitro maturation (IVM) investigations suggest the potential for wider clinical application.  View the Committee Opinion
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Fertility treatment when the prognosis is very poor or futile: an Ethics Committee opinion (2019)

The Ethics Committee recommends that in vitro fertilization (IVF) centers develop patient-centered policies regarding requests for futile treatment.  View the Committee Opinion
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Blastocyst culture and transfer in clinically assisted reproduction: a committee opinion (2018)

The purposes of this document is to review the literature regarding the clinical application of blastocyst transfer. View the Committee Opinion
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The role of immunotherapy in in vitro fertilization: a guideline (2018)

Adjuvant immunotherapy treatments in in vitro fertilization (IVF) aim to improve the outcome of assisted reproductive technology (ART) in both the general ART population as well as subgroups such as patients with recurrent miscarriage or implantation failure. View the Committee Opinion
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Performing the embryo transfer: a guideline (2017)

A systematic review of the literature was conducted which examined each of the major steps of embryo transfer. Recommendations made for improving pregnancy rates are based on interventions demonstrated to be either beneficial or not beneficial. (Fertil Steril® 2017;107:882–96. ©2017 by American Society for Reproductive Medicine.) View the Committee Guideline
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Prevention and treatment of moderate and severe ovarian hyperstimulation syndrome: a guideline (2016)

Ovarian hyperstimulation syndrome (OHSS) is an uncommon but serious complication associated with assisted reproductive technology. View the guideline
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Financial ‘‘risk-sharing’’ or refund programs in assisted reproduction: an Ethics Committee opinion (2016)

Financial ‘‘risk-sharing’’ fee structures in assisted reproduction programs charge patients a higher initial fee but provide reduced fees for subsequent cycles and often a partial or complete refund if treatment fails. View the Committee Document
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Best practices of ASRM and ESHRE: a journey through reproductive medicine (2012)

ASRM and ESHRE are the two largest societies in the world whose members comprise the major experts and professionals working in reproductive medicine. View the Committee Joint Guideline
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In Vitro Maturation Special Interest Group (IVMSIG)

IVMSIG strives to define the best strategies to optimize IVM outcomes. Learn more about IVMSIG