RecruitingPhase 1NCT05980091

Optimal Timing of Euploid Day 6 Blastocyst Transfer in Frozen HRT Cycles, Day 6 or Day 7 of Progesterone Administration.

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?


Sponsor

ART Fertility Clinics LLC

Enrollment

316 participants

Start Date

Sep 22, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 43 Years

Inclusion Criteria3

  • Women aged 18 years to 43 years.
  • Having at least 1 euploid cryopreserved day 6 blastocyst of at least Grade BB quality.
  • Endometrial trilaminar appearance on the day of progesterone start

Exclusion Criteria7

  • Uterine abnormality
  • Hydrosalpinx
  • Asherman syndrome
  • Any known contraindications or allergy to oral estradiol or progesterone.
  • Intention to treat : exclusion factors :
  • Spontaneous ovulation HRT cycle
  • Discontinuation of HRT medication

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Interventions

DIAGNOSTIC_TESTTransvaginal ultrasound

Transvaginal ultrasound throughout the HRT cycle to not only monitor endometrial development but to also exclude the presence of an ovarian dominant follicle

DIAGNOSTIC_TESTSerum LH, E2, P4

In conjunction with ultrasound monitoring, participants will undergo serial measurements of serum Luteinizing Hormone (LH), Estradiol (E2) and Progesterone (P4) levels

DRUGEstradiol 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)

DRUGProgesterone 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

DIAGNOSTIC_TESTSerum P4 day of ET

On the day of embryo transfer (ET), a blood test is taken to measure serum P4

PROCEDUREEmbryo 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

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NCT05980091


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