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Optimal Timing of Euploid Day 6 Blastocyst Transfer in Frozen HRT Cycles, Day 6 or Day 7 of Progesterone Administration.
Sponsor: ART Fertility Clinics LLC
Summary
The goal of this study is to compare the difference in clinical pregnancy, miscarriage and livebirth rate between day 6 euploid blastocyst transfer on the 6th and the 7th day of progesterone exposure in Hormonal Replacement Therapy (HRT) FET cycles. This prospective \& randomized study will only include euploid day 6 blastocysts. This will be the first prospective study of euploid day 6 blastocysts thereby excluding aneuploidy as a cause of miscarriage and implantation failure. The point of randomization will occur on the day of progesterone commencement.
Official title: Optimal Timing of Euploid Day 6 Blastocyst (blastocyst Which Was Biopsied on Day 6 After Fertilization) Transfer in Frozen Hormonal Replacement Therapy Cycles: Day 6 or Day 7 of Progesterone Administration?
Key Details
Gender
FEMALE
Age Range
18 Years - 43 Years
Study Type
INTERVENTIONAL
Enrollment
316
Start Date
2023-09-22
Completion Date
2025-12-30
Last Updated
2025-02-21
Healthy Volunteers
Yes
Interventions
Transvaginal ultrasound
Transvaginal ultrasound throughout the HRT cycle to not only monitor endometrial development but to also exclude the presence of an ovarian dominant follicle
Serum LH, E2, P4
In conjunction with ultrasound monitoring, participants will undergo serial measurements of serum Luteinizing Hormone (LH), Estradiol (E2) and Progesterone (P4) levels
Estradiol Valerate 2 MG
Participants will commence estradiol valerate 4 mg ( 2 x 2 mg) on day 2 / day 3 of menses. Estradiol will be increased to 6 mg on day 2 of estrogen treatment, and continued at a daily dose of 6 mg (3 tablets daily)
Progesterone 100 Mg Vaginal Insert
The initial progesterone dose of 100 mg will be commenced at 13hrs and repeated at 21hrs considered day 1 (vaginal suppository) when an optimal endometrial thickness for each participant has been achieved with a trilaminar appearance. The following day (day 2) progesterone administration will be increased to 100 mg vaginally three times daily
Serum P4 day of ET
On the day of embryo transfer (ET), a blood test is taken to measure serum P4
Embryo transfer
Procedure in which embryo is transferred into the uterus
Locations (2)
ART Fertility Clinics LLC
Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates
ART Fertility Clinics Dubai
Dubai, United Arab Emirates