GnRH Agonist for Luteal Phase Support.

Not Applicable

• Conditions: Use of GnRH Agonist Alone for Luteal Phase Support in Fresh IVF Cycles
• Interventions: Drug: GnRH agonist; Drug: Progesterone

• Registration Number: NCT05484193
• Lead Sponsor: Shaare Zedek Medical Center

Brief Summary

Objective To assess the the efficacy of luteal support with GnRH agonist in patients undergoing IVF in antagonist-based hcg triggered cycles compared with standard luteal support with progesterone.

Design prospective randomized controled study Subjects Patients who underwent antagonist-based cycles performed in the "Shaare Zedek Medical Center" IVF clinic between 2020 and 2022 Intervention Intranasal GnRH-agonist or vaginal Progesterone for luteal support.

Main outcome measures Pregnancy and clinical pregnancy rates, ohss.

The study cohort included 150 patients who underwent 164 cycles. A total of 127 cycles were included. Of them, 64 were treated with GnRH-a and 63 with progesterone.

Hypothesis: This RCT suggests that GnRH-a for luteal phase support is associated with a higher positive β-hCG pregnancy rate and clinical pregnancy rate, compared with standard progesterone support in an antagonist-based protocol triggered with hCG, while maintaining a similar safety profile.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-08
• Primary Completion: 2022-04-15
• Status Verified: 2022-07
• Study First Submitted: 2022-07-31
• Study First Submitted QC: 2022-08-01
• Last Update Submitted: 2022-08-01
• Study First Posted: 2022-08-02
• Last Update Posted: 2022-08-02
• Study Completion: 2023-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

Criteria for inclusion were patients aged between 18-45 years, BMI between 19-35, infertility diagnosis of male factor, tubal factor, anovulation, unexplained and age-related. Patients with or without infertility diagnosis, who underwent IVF for PGT were also included.

Exclusion Criteria

Exclusion criteria were triggering with agents other than hCG, previous 3 or more failed cycles in which a good quality embryo or embryos were transferred, endometriosis, hydrosalpinx, hypogonadotropic hypogonadism, and Mullerian malformations. Drop-out criteria included no fresh embryo transfer, intolerance to GnRH-a, and nasal congestion during the luteal phase.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GnRH-agonist group	GnRH agonist	In the GnRH-a group, LPS was initiated on the evening after the OPU, using Nafareline (Synarel nasal spray 200mg used once), followed by twice daily (total 400mg/day) until the day of serum β-hCG pregnancy test, and then stopped, regardless of the test results
Progesterone group	Progesterone	In the progesterone group, LPS was initiated on the morning after OPU, using micronized progesterone ( PV Utrogestan 300mg, 3 times daily), until serum β-hCG pregnancy tests results were available. If a β-hCG pregnancy was confirmed, LPS was continued until the end of the 8th gestational week

Primary Outcome Measures

Name	Time	Method
pregnancy	2 weeks	- positive Bhcg

Secondary Outcome Measures

Name	Time	Method
clinical pregnancy	5 weeks	gestational sac with heartbeat
ovarian hyperstimulation syndrome	5 weeks	early and late

Trial Locations

Locations (1)

Shaare Zedek medical Center; 🇮🇱 Jerusalem, Israel