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

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.

Conditions

• Infertility
• Fertility Issues
• Infertility, Female

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

Sponsors & Collaborators

• ART Fertility Clinics LLC

  lead OTHER

Principal Investigators

• Carol Coughlan, PhD · ART Fertility Clinics LLC

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

43 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-09-22

Primary Completion

2025-12-30

Completion

2025-12-30

Countries

• United Arab Emirates

Study Locations