RecruitingPhase 1NCT05969795

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)

Sponsor

ART Fertility Clinics LLC

Enrollment

342 participants

Start Date

Sep 5, 2023

Study Type

INTERVENTIONAL

Conditions

Infertility, Female Pregnancy Related

Summary

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

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Embryo transfer, a drug called Progesterone 100 Mg Vaginal Insert, and others for people with infertility, female and pregnancy related. The study is currently recruiting participants at 3 locations. People eligible for this study include women aged 18 Years to 40 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTTransvaginal ultrasound

Intermittent transvaginal ultrasound throughout the cycle to monitor follicular growth

DIAGNOSTIC_TESTSerial 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).

DRUGProgesterone 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_TESTSerum 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_TESTSerum P4 day of ET - Study Group

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

PROCEDUREEmbryo transfer

The procedure in which embryo is placed in the uterus.

DIAGNOSTIC_TESTSerum 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_TESTSerum 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