Both slowly developing embryos and a variable pace of luteal endometrial progression may conspire to prevent normal birth in spite of a capable embryo.
Jason M Franasiak, Maria Ruiz-Alonso, Richard T Scott...
https://pubmed.ncbi.nlm.nih.gov/26940791Actively Recruiting
Led by ART Fertility Clinics LLC · Updated on 2025-02-21
316
Participants Needed
2
Research Sites
N/A
Total Duration
Researchers are comparing the timing of transferring euploid day 6 blastocysts in frozen Hormonal Replacement Therapy (HRT) cycles, specifically whether transfer on the 6th or 7th day of progesterone exposure leads to better outcomes in clinical pregnancy, miscarriage, and live birth rates. This study is the first to focus exclusively on euploid day 6 blastocysts to remove the effect of aneuploidy on implantation failure and miscarriage. The timing of progesterone exposure is randomized at the start of progesterone treatment. Participants will receive estradiol valerate starting on day 2 or 3 of menstruation, increasing to a daily dose of 6 mg. Progesterone vaginal suppositories begin when the endometrium shows optimal thickness and a trilaminar appearance, starting with 100 mg doses twice on day 1 and then three times daily from day 2. Embryo transfer is scheduled either on the 6th or 7th full day after starting progesterone. Throughout the HRT cycle, participants undergo transvaginal ultrasounds and blood tests measuring hormone levels, including serum progesterone on the day of embryo transfer. Participants will be monitored with ultrasounds and hormone tests to track endometrial development and hormone levels. The primary outcome measured is live birth rate at 41 weeks. Secondary outcomes include biochemical pregnancy rates, clinical pregnancy rates, ongoing pregnancy rates at 13 weeks, and miscarriage rates at 24 weeks. The study involves careful monitoring to exclude ovarian follicles and assess hormone levels to optimize timing of embryo transfer. Total participation duration is aligned with pregnancy outcomes and follow-up.
CONDITIONS
Optimal Timing of Euploid Day 6 Blastocyst Transfer in Frozen HRT Cycles, Day 6 or Day 7 of Progesterone Administration.
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You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 weeks
Participants receive hormonal replacement therapy with estradiol valerate and progesterone to prepare the endometrium for embryo transfer. The timing of embryo transfer is either on the 6th or 7th full day of progesterone administration depending on group assignment.
Multiple visits for hormone monitoring and embryo transfer procedure
Duration - Up to 41 weeks
Participants are followed for pregnancy outcomes including biochemical and clinical pregnancy rates, ongoing pregnancy, miscarriage, and live birth.
Several visits up to 41 weeks for pregnancy monitoring
Total: 2 locations
1
ART Fertility Clinics LLC
Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates, 60202
Actively Recruiting
2
ART Fertility Clinics Dubai
Dubai, United Arab Emirates
Actively Recruiting
B
Barbara Lawrenz, PhD
J
Jonalyn Edades, RN
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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