Mosaic Embryo Transfer for Infertility

Overseen By Rachel Makloski, RN

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Colorado Center for Reproductive Medicine

Disqualifiers: Gestational carrier, Chromosome errors 13, 18, 21, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 week

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of transferring a mosaic embryo (an embryo with both normal and abnormal cells) for women facing infertility. It focuses on those who have already undergone in vitro fertilization (IVF) with genetic testing at the Colorado Center for Reproductive Medicine. Women who have completed this process and have a mosaic embryo ready for transfer may be suitable candidates. The trial will assess the outcomes of transferring a single mosaic embryo to the uterus. As an unphased trial, this study provides a unique opportunity to contribute to pioneering research in reproductive medicine.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that Mosaic Embryo Transfer is safe for infertility treatment?

Research has shown that using mosaic embryos, which contain a mix of normal and abnormal cells, does not increase the risk of birth defects. Recent evidence suggests that this process is safe for birth outcomes. However, the likelihood of pregnancy is lower with these embryos compared to those without mosaicism. Studies indicate that embryos with a high level of mosaicism have an even lower chance of implanting in the womb and leading to pregnancy.

In summary, while mosaic embryos do not raise the risk of birth defects, they are less likely to result in pregnancy. These factors are important to consider when deciding to participate in a study involving mosaic embryo transfer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Mosaic Embryo Transfer is unique because it offers a new option for women undergoing IVF by utilizing embryos with a mix of normal and abnormal cells, known as mosaic embryos. Unlike traditional IVF, which generally selects only embryos with entirely normal cells for transfer, this approach opens the door for potentially viable embryos that might otherwise be discarded. Researchers are excited about this method because it could increase the chances of pregnancy for women who have limited embryos available, providing new hope for those struggling with infertility.

What evidence suggests that Mosaic Embryo Transfer might be an effective treatment for infertility?

Research has shown that transferring mosaic embryos, a procedure participants in this trial will undergo, can lead to successful pregnancies. One study found that 40.1% of these embryos implanted successfully. Other studies have found that up to 30% of mosaic embryo transfers result in healthy births, although there is a 20% chance of miscarriage. Embryos with fewer chromosomal issues have a better chance of success. These findings suggest that mosaic embryo transfer can be a promising option for some people trying to conceive, despite the risks. ^{1 2 5 6 7}

Who Is on the Research Team?

Mandy Katz-Jaffe, PhD

Principal Investigator

Fertility Genetics

Are You a Good Fit for This Trial?

This trial is for women aged 18-45 who are infertile and have completed an IVF cycle with PGT at CCRM, possessing a mosaic embryo. They must be willing to transfer only one embryo and meet the clinic's standards for an embryo transfer. It excludes those desiring multiple embryos, using gestational carriers, or having certain chromosomal errors.

Inclusion Criteria

I am a woman aged between 18 and 45.

Infertile women who have completed an IVF cycle with PGT at the Colorado Center for Reproductive Medicine (CCRM) that have a mosaic embryo

Anyone can participate in the study regardless of their race, culture, sexual orientation, or ethnicity.

Exclusion Criteria

I want more than one embryo transferred.

Patients that did not complete their IVF with PGT cycle at the Colorado Center for Reproductive Medicine.

Patients that are using a gestational carrier.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Transfer of a mosaic embryo to the uterus after in vitro fertilization with preimplantation genetic testing

1 week

1 visit (in-person)

Follow-up

Participants are monitored for implantation and live birth rates, as well as miscarriage and stillbirth rates

12-15 months

Multiple visits (in-person and virtual)

Neonatal Outcomes

Assessment of the health of the infant, noting any medical problems

12-15 months after birth

What Are the Treatments Tested in This Trial?

Interventions

• Mosaic Embryo Transfer

Trial Overview

The study investigates the outcomes of transferring a single mosaic embryo (with both normal and abnormal cells) after preimplantation genetic testing in infertile women. The focus is on understanding the success rate and potential risks associated with such transfers.

How Is the Trial Designed?

Group I: Transfer of mosaic embryo Experimental Treatment 1 Intervention

Women will have a mosaic embryo transferred to their uterus after in vitro fertilization (IVF) with pre implantation genetic testing completed at Colorado Center for Reproductive Medicine.

Mosaic Embryo Transfer is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Mosaic Embryo Transfer for:

• Infertility treatment for individuals lacking euploid embryos

Approved in United States as Mosaic Embryo Transfer for:

• Infertility treatment for individuals lacking euploid embryos

Approved in Canada as Mosaic Embryo Transfer for:

• Infertility treatment for individuals lacking euploid embryos

Approved in Japan as Mosaic Embryo Transfer for:

• Infertility treatment for individuals lacking euploid embryos

Approved in China as Mosaic Embryo Transfer for:

• Infertility treatment for individuals lacking euploid embryos

Approved in Switzerland as Mosaic Embryo Transfer for:

• Infertility treatment for individuals lacking euploid embryos

Who Is Running the Clinical Trial?

Colorado Center for Reproductive Medicine

Lead Sponsor

Trials

7

Recruited

700+

Published Research Related to This Trial

Mosaic embryos, which have genetically distinct cell lines, can lead to healthy live births, but careful selection and monitoring are essential to prevent severe adverse outcomes like implantation failure and congenital malformations.

Genetic counseling and prenatal diagnosis are critical components of the process when transferring mosaic embryos to ensure the safety and health of both the mother and the offspring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Research progress on mosaic embryo transfer and pregnancy risk]. Song, YW., Jin, M.[2023]

Mosaic embryos, particularly those with less than 50% aneuploidy, have shown reproductive potential, yielding live birth rates comparable to euploid embryos, which is significant given the increasing identification of these embryos due to improved diagnostic techniques.

The review emphasizes the need for proper guidelines to select suitable mosaic embryos for transfer, aiming to reduce embryo wastage and enhance the success rates of embryo transfers in assisted reproductive technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preimplantation genetic testing for aneuploidy: The management of mosaic embryos. Yu, EJ., Kim, MJ., Park, EA., et al.[2022]

In a study of 1910 embryos from 544 couples undergoing preimplantation genetic testing, 6.6% were found to be mosaic, indicating a notable incidence of this condition in assisted reproductive technology.

The incidence of mosaic embryos was significantly higher in those created via IVF compared to ICSI, and also increased with the use of abnormal semen, highlighting the importance of semen quality and fertilization method in embryo development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors influencing mosaicism: a retrospective analysis. Huang, QX., Wang, ZH., Huang, WJ., et al.[2022]

Euploid embryo transfers (EET) resulted in significantly higher implantation rates (47.0%) and live birth rates (40.7%) compared to mosaic embryo transfers (MET), which had rates of 39.0% and 28.8%, respectively, indicating that euploid embryos are more effective for achieving successful pregnancies.

Segmental mosaic embryos showed comparable implantation and live birth rates to euploid embryos, while those with a high percentage of aneuploid cells (≥60%) had a significantly lower live birth rate (10.5%), suggesting that such embryos should be prioritized lower for transfer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neonatal and clinical outcomes after transfer of a mosaic embryo identified by preimplantation genetic testing for aneuploidies. Yakovlev, P., Vyatkina, S., Polyakov, A., et al.[2022]

Mosaic embryo transfers during IVF are becoming more common, and recent studies indicate that these transfers can lead to normal prenatal outcomes, including healthy pregnancies and births.

Despite the potential for successful outcomes, there is a need for more research to establish best practices for counseling patients about mosaic embryo transfers, as well as improved communication between reproductive and prenatal care providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pregnancy from mosaic embryo transfer: genetic counseling considerations. Chen, K., Darcy, D., Boyd, A.[2023]

A healthy baby was successfully born from a mosaic embryo transfer after in vitro maturation (IVM) of oocytes, demonstrating the potential for mosaic embryos to result in normal pregnancies.

Despite initial concerns about the embryo being mosaic for chromosomes 13 and 21, both prenatal tests and post-birth genetic testing confirmed the baby was chromosomically normal, suggesting that mosaic embryos can still lead to healthy outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mosaic embryo transfer after oocyte in vitro maturation in combination with non-invasive prenatal testing (NIPT)-first report of a euploid live birth. Inoue, N., Lopez, R., Delgado, A., et al.[2018]

Mosaic embryos, which contain both normal (euploid) and abnormal (aneuploid) cells, can lead to live births, with 440 healthy babies reported from the transfer of 2155 such embryos, although they have lower implantation rates and higher miscarriage rates compared to euploid embryos.

Despite the potential for healthy pregnancies, the risk of chromosomal abnormalities persists in some cases, making genetic counseling essential for patients considering the transfer of mosaic embryos.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The mosaic embryo: what it means for the doctor and the patient. Greco, E., Greco, PF., Listorti, I., et al.[2023]

In a study analyzing 28 preimplantation genetic testing cycles, 35.7% of transferred mosaic embryos successfully implanted, leading to gestational sacs, indicating some potential for pregnancy despite the embryos being mosaic.

Out of the pregnancies achieved, 5 women delivered healthy babies, although there were also miscarriages, highlighting the importance of informing patients about the risks associated with transferring mosaic embryos when no normal embryos are available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The outcome of human mosaic aneuploid blastocysts after intrauterine transfer: A retrospective study. Hong, B., Hao, Y.[2020]

In a study involving 70 patients who underwent IVF, transferring mosaic embryos resulted in implantation and pregnancy outcomes that were only slightly different from those achieved with fully normal embryos.

The study emphasizes the importance of accurately interpreting mosaic embryo results and suggests that proper patient counseling and prenatal testing are essential for managing potential risks associated with these embryos.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The outcomes after transfers of embryos with chromosomal mosaicism: a single reproductive medicine center experience at iVF Riga clinic. Alksere, B., Grinfelde, I., Kornejeva, L., et al.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7565393/

The Pregnancy Outcome of Mosaic Embryo Transfer

Among the 137 mosaic embryos transferred, 55 embryos from 54 FET cycles were successfully implanted (IR: 40.1%, 55/137) with statistical ...

2.

fertstert.org

fertstert.org/article/S0015-0282(23)00388-6/fulltext

MOSAIC EMBRYO TRANSFER VERSUS ADDITIONAL IVF ...

Recent studies(1–3) have shown that the transfer of mosaic embryos can lead to healthy live births in up to 30% of transfers with a miscarriage rate of 20%.

3.

asrm.org

asrm.org/practice-guidance/practice-committee-documents/clinical-management-of-mosaic-results-from-preimplantation-genetic-testing-for-aneuploidy-pgt-a-of-blastocysts-a-committee-opinion/

Clinical management of mosaic results from ...

Current prospective MET data indicate reduced pregnancy potential of embryos reported as mosaic for 3 or more chromosomes as compared with those with one or 2 ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04472156?term=embryo%20transfer%20mosaic&rank=1

A Prospective Study of a Mosaic Embryo Transfer

This research is a prospective study with the purpose is to investigate the clinical outcomes following the transfer of a mosaic embryo (presence of both ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S0015028221005276

The “mosaic” embryo: misconceptions and ...

As shown in Table 1, several studies have reported successful outcomes after the transfer of “mosaic" embryos, and, coincidently, with an overall success rate ...

6.

academic.oup.com

academic.oup.com/humrep/article/40/Supplement_1/deaf097.266/8170414

O-266 Decoding the clinical fate of segmental mosaic embryos

Higher segmental mosaicism levels reduce implantation and pregnancy rates. Specific chromosomes are linked to implantation failure, underscoring ...

7.

rbmojournal.com

rbmojournal.com/article/S1472-6483(22)00150-X/fulltext

PGDIS position statement on the transfer of mosaic ...

Recent data suggest that such mosaic embryos can be transferred without added risk of abnormal birth outcomes but may be associated with ...