NCT05969795

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

Comparison of Live Birth Rate (> 24 Weeks) in Natural Cycle (NC) Single Euploid Frozen Embryo Transfers (FET) With Versus Without Luteal Phase Support (LPS)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 342 (estimated)
• Sponsor: ART Fertility Clinics LLC · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

To evaluate whether single euploid embryo transfer in NC without routinely administered LPS is non-inferior to NC with routinely administered LPS.

Detailed description

In case the study will show that the live birth rate in single euploid NC frozen embryo transfer cycles without LPS is not inferior to NC cycles with LPS, treatment can be simplified, and participants comfort can be increased.

Conditions

• Pregnancy Related
• Infertility, Female

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-09-05
• Primary completion: 2026-04-30
• Completion: 2026-09-30
• First posted: 2023-08-01
• Last updated: 2025-01-09

Locations

3 sites across 1 country: United Arab Emirates