GnRH Agonist for Luteal Phase Support.

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Pregnancy Rates After Luteal Phase Support With GnRH Agonist Versus Progesterone - a Prospective Randomized Study

Conditions
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Use of GnRH Agonist Alone for Luteal Phase Support in Fresh IVF Cycles

Intervention / Treatment
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* Drug: GnRH agonist
* Drug: Progesterone


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GnRH-agonist group<br>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 | Drug: GnRH agonist<br>* GnRH agonist alone for luteal phase support in fresh IVF embryo transfer cycles<br>* Other names: Synarel;|
| Active Comparator: Progesterone group<br>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 | Drug: Progesterone<br>* vaginal progesterone for luteal phase support<br>* Other names: Utrogestan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy | - positive Bhcg | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy | gestational sac with heartbeat | 5 weeks | 
| ovarian hyperstimulation syndrome | early and late | 5 weeks |