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RECRUITING
NCT05980091
PHASE1

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

View on ClinicalTrials.gov

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

DIAGNOSTIC_TEST

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

DIAGNOSTIC_TEST

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

DRUG

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)

DRUG

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

DIAGNOSTIC_TEST

Serum P4 day of ET

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

PROCEDURE

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