Comparison of Live Birth Rate in Natural Cycle Single Euploid FET Versus Without Luteal Phase Support

PHASE1RecruitingINTERVENTIONAL
Enrollment

342

Participants

Timeline

Start Date

September 5, 2023

Primary Completion Date

April 30, 2026

Study Completion Date

September 30, 2026

Conditions
Pregnancy RelatedInfertility, Female
Interventions
DIAGNOSTIC_TEST

Transvaginal ultrasound

Intermittent transvaginal ultrasound throughout the cycle to monitor follicular growth

DIAGNOSTIC_TEST

Serial serum LH, E2, P4

Serial measurements of serum Luteinizing Hormone (LH), Estradiol (E2) and Progesterone (P4 )levels throughout the cycle to determine ovulation. LH-surge is identified when a rise of 180% above the previous level occurred and ovulation is confirmed with a decrease in E2 concentration, and a rise of progesterone level to ≥ 1.0 ng/ml (Irani et al., 2017).

DRUG

Progesterone 100 Mg Vaginal Insert

On day of ET procedure, to administer 200 mg of vaginal progesterone and increase to 300 mg/day from the day after the ET onwards until the pregnancy test. In case of an implantation, vaginal P4 will be continued until 7 weeks of pregnancy

DIAGNOSTIC_TEST

Serum P4 day of ET - Control Group

Serum P4 will be drawn before starting LPS in form of vaginal progesterone on the day of ET procedure

DIAGNOSTIC_TEST

Serum P4 day of ET - Study Group

Serum P4 will be drawn when study group participants are admitted to the clinic for the ET procedure.

PROCEDURE

Embryo transfer

The procedure in which embryo is placed in the uterus.

DIAGNOSTIC_TEST

Serum hCG 10 days after ET

Pregnancy will be confirmed / excluded by measurement of serum hCG 10 days after ET procedure and a level of \> 15 IU will be regarded as positive result. The definitions of biochemical, ectopic, clinical and ongoing pregnancy follow the ICMART criteria (Zegers-Hochschild, 2006)

DIAGNOSTIC_TEST

Serum P4 10 days after ET

Serum P4 will be drawn on day 5 or day 6 after the ET procedure and together with the hCG 10 days after ET procedure

Trial Locations (3)

60202

RECRUITING

ART Fertility Clinics LLC, Abu Dhabi

Unknown

RECRUITING

ART Fertility Clinics Al Ain, Al Ain City

NOT_YET_RECRUITING

ART Fertility Clinics Dubai, Dubai

All Listed Sponsors
lead

ART Fertility Clinics LLC

OTHER