Infertility
Conditions
Brief summary
The trial objective is to determine whether the deferred transfer of embryos following cryopreservation at the blastocyst stage following pre-implantation genetic screening (PGS-FET) improves live birthrates compared to both the deferred transfer of cryopreserved embryos without PGS (FET) and immediate transfer at the conclusion of a fresh in vitro fertilization (IVF) cycle (Fresh). Additionally, whether freeze-only (FET) improves live birth rates compared to fresh will be determined.
Detailed description
This will be a multi-center, prospective randomized clinical trial comparing three standards of care: Group 1: PGS-FET group: deferred transfer of day 5/6/7 (blastocyst stage) embryos cryopreserved following trophectoderm biopsy Group 2: freeze-only (FET) group: deferred transfer of frozen/thawed embryos without biopsy Group 3: fresh ET group: immediate transfer of fresh embryos in the stimulation cycle. 1539 eligible couples will be recruited to participate. Couples will be randomized at retrieval to undergo cryopreservation with deferred embryo transfer, with or without PGS, or fresh embryo transfer during the cycle of egg retrieval. Number of embryos to transfer will be based on clinical estimation of embryo quality and will not exceed ASRM guidelines for embryo transfer number including newly revised guidelines. We are aware that the number of embryos transferred, to maintain enrollment, may not be equivalent, with likely more embryos transferred in patients not having PGS. The primary outcome of live birth/retrieval, with a secondary outcome of healthy singleton birth, may reflect the true benefit of PGS.
Interventions
PROCEDURETrophectoderm biopsy
Biopsy at blastocyst stage of trophectoderm cells for comprehensive evaluation of the eupolid status of the embryo.
PROCEDURECryopreservation
Rapid freezing using vitrification
PROCEDUREEmbryo Transfer
Transfer of embryo that has been cultured in vitro into the uterus
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of California, San Francisco
University of Pennsylvania
Augusta University
Penn State University
University of North Carolina
University of Oklahoma
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
No
Inclusion criteria
* Scheduled to undergo in vitro fertilization for treatment of infertility (1st or 2nd fresh attempt); subject can have had no more than one prior failed fresh IVF cycle * Couple able to participate in a research project * Able to understand study requirements * Willing to sign informed consent * Able to return for required follow-up * Access to telephone * Ability to read and write * Normal uterine cavity evaluation within one year of enrollment
Exclusion criteria
* Medical conditions which may complicate treatment * No plans to undergo embryo transfer * Medical contraindication to the transfer of more than a single embryo (i.e. congenital uterine anomaly). * Concurrent participation in any other interventional trial * Recurrent pregnancy loss * Known chromosomal abnormality (e.g. translocation) * Pre-implantation genetic diagnosis requiring blastocyst biopsy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Live Birth | up to 9 months or time of birth | The number of subjects who deliver a live born infant which will be calculated into a live born delivery rate. |
Countries
United States
Outcome results
None listed