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Comparison of Pregnancy Rates in Modified Natural Frozen Embryo Transfer (FET) Cycle After Luteal Support with GnRH Agonist Versus Progesterone

NCT06870266 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-03-11

No results posted yet for this study

Summary

Background:

The capability to transfer frozen embryos reduces embryo loss following in vitro fertilization (IVF) and results in higher pregnancy rates compared to a single IVF cycle.

Endogenous progesterone from the corpus luteum, following frozen embryo transfer in natural or modified natural cycles, is expected to provide sufficient luteal support, as observed in spontaneous pregnancies. Nevertheless, research has demonstrated higher pregnancy success rates with additional luteal support. The current standard for luteal phase support involves vaginal progesterone administration.

Several case reports have indicated that administering a gonadotropin-releasing hormone (GnRH) agonist during the luteal phase does not compromise pregnancy continuation achieved through IVF and may, in fact, enhance implantation success.

Studies have shown that the luteal phase can be maintained with a GnRH agonist alone, without the need for progesterone supplementation.

A recent prospective randomized controlled trial compared standard progesterone support with GnRH agonist support in fresh embryo transfers. The group receiving GnRH agonist support demonstrated a significantly higher pregnancy rate.

Given the studies proving the positive impact of GnRH agonist, there is a need for a prospective randomized controlled trial to evaluate the use of GnRH agonist support in frozen embryo transfers.

Aims and Significance:

This study aims to compare pregnancy rates between women receiving GnRH agonist treatment and those receiving standard progesterone-based luteal support during frozen embryo transfers in natural cycles as part of IVF treatments.

Conducting a prospective comparative study will enable us to assess the effectiveness of GnRH agonist treatment relative to standard luteal phase support. Based on the results, the investigators may consider treatment with intranasal GnRH agonist, which improves quality of life and may also enhance pregnancy and live birth rates.

Methods:

The study will be conducted on patients scheduled to undergo modified natural cycles. Participants will be randomly allocated into two groups:

1. Study Group: Luteal phase support will begin on the day of ovulation with Nafarelin nasal spray (200 mcg twice daily) for two weeks, until pregnancy blood test (hCG).
2. Control Group: Luteal phase support will be provided through vaginal progesterone. Endometrin 100 mg twice daily. If the hCG test is positive, the supportive treatment will continue until the 8th week of pregnancy, as per the attending physician's instructions.

Clinical follow-up will include monitoring for clinical pregnancy outcomes, miscarriage rates, and live births.

Conditions

  • Ivf
  • Frozen Embryo Transfer (FET)

Interventions

DRUG

Nafarelin nasal spray

NAFARLIN 200 MCG X2 DAY

DRUG

Utrogestan®

UTROGESTAN 200 MG X2 DAY

Sponsors & Collaborators

  • Shaare Zedek Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-31
Primary Completion
2027-03-31
Completion
2027-06-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06870266 on ClinicalTrials.gov