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

ART Fertility Clinics LLC

Status and phase: Enrolling; Phase 1

Conditions: Pregnancy Related; Infertility, Female

Treatments: Diagnostic Test: Serum P4 day of ET - Study Group; Diagnostic Test: Serum P4 10 days after ET; Drug: Progesterone 100 Mg Vaginal Insert; Diagnostic Test: Serum hCG 10 days after ET; Procedure: Embryo transfer; Diagnostic Test: Transvaginal ultrasound; Diagnostic Test: Serial serum LH, E2, P4; Diagnostic Test: Serum P4 day of ET - Control Group

Study type: Interventional

Funder types: Other

Identifiers

NCT05969795

2306-ABU-009-BL

Details and patient eligibility

About

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

Full 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.

Enrollment: 342 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age: 18 to 40 years
• Regular ovulatory cycles
• Availability of at least one euploid embryo after Trophectoderm biopsy for PGT-A on day 5 or day 6
• Detection of ovulation by P4 rise > 1.0 ng/ml after LH surge
• P4 value of at least 5 ng/ml on day 4 after ovulation

Exclusion criteria

• History of repeated pre-menstrual spotting
• Factors affecting the implantation through anatomical changes of the uterus / ovaries or the tubes (adenomyosis, Asherman syndrome, endometriosis, uterine fibroids / polyps, isthmocele with intracavitary fluid presence, hydrosalpinx....)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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342 participants in 2 patient groups

Study Group

Other group

Description:

Intermittent ultrasound scans to monitor follicular growth and serial measurements of serum LH, E2 and P4 levels throughout the cycle to determine ovulation. Embryo transfer (ET) will be scheduled on the fifth day after ovulation. Blood for P4 measurement will be drawn upon admission to the clinic for the ET procedure. P4 will be measured on day 5 or day 6 after the ET procedure and together with the hCG 10 days after ET procedure.

Treatment:

Diagnostic Test: Serial serum LH, E2, P4

Diagnostic Test: Transvaginal ultrasound

Diagnostic Test: Serum hCG 10 days after ET

Procedure: Embryo transfer

Diagnostic Test: Serum P4 10 days after ET

Diagnostic Test: Serum P4 day of ET - Study Group

Control Group

Other group

Description:

Intermittent ultrasound scans to monitor follicular growth and serial measurements of serum LH, E2 and P4 levels throughout the cycle to determine ovulation. Embryo transfer (ET) will be scheduled on the fifth day after ovulation. Administer on FET day 200 mg of P4 and increase to 300 mg/day from the day after the ET onwards until the pregnancy test. Blood for P4 measurement will be drawn before starting LPS in form of vaginal progesterone. P4 will be measured on day 5 or day 6 after the ET procedure and together with the hCG 10 days after ET procedure. In case of an implantation, vaginal P4 will be continued until 7 weeks of pregnancy.

Treatment:

Diagnostic Test: Serum P4 day of ET - Control Group

Diagnostic Test: Serial serum LH, E2, P4

Diagnostic Test: Transvaginal ultrasound

Diagnostic Test: Serum hCG 10 days after ET

Procedure: Embryo transfer

Diagnostic Test: Serum P4 10 days after ET

Drug: Progesterone 100 Mg Vaginal Insert