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

Summary

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

Conditions

• Pregnancy Related
• Infertility, 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

Sponsors & Collaborators

• ART Fertility Clinics LLC

  lead OTHER

Principal Investigators

• Barbara Lawrenz, PhD · ART Fertility Clinics LLC

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-09-05

Primary Completion

2026-04-30

Completion

2026-09-30

Countries

• United Arab Emirates

Study Locations