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GnRH Agonist for Luteal Phase Support.

Sponsor
Shaare Zedek Medical Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05484193
Collaborator
(none)
150
Enrollment
1
Location
2
Arms
30.8
Anticipated Duration (Months)
4.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of Pregnancy Rates After Luteal Phase Support With GnRH Agonist Versus Progesterone - a Prospective Randomized Study
Actual Study Start Date :
Jun 8, 2020
Actual Primary Completion Date :
Apr 15, 2022
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: GnRH-agonist group

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
GnRH agonist alone for luteal phase support in fresh IVF embryo transfer cycles
Other Names:
  • Synarel

    		•
    Active Comparator: Progesterone group

    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
    vaginal progesterone for luteal phase support
    Other Names:
  • Utrogestan

    		•

    Outcome Measures

    Primary Outcome Measures

    1. pregnancy [2 weeks]

      - positive Bhcg

    Secondary Outcome Measures

    1. clinical pregnancy [5 weeks]

      gestational sac with heartbeat

    2. ovarian hyperstimulation syndrome [5 weeks]

      early and late

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes

    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.

    -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shaare Zedek medical Center Jerusalem Israel

    Sponsors and Collaborators

    • Shaare Zedek Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shaare Zedek Medical Center
    ClinicalTrials.gov Identifier:
    NCT05484193
    Other Study ID Numbers:
    • Synarel fresh LPS
    First Posted:
    Aug 2, 2022
    Last Update Posted:
    Aug 2, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Progesterone

    Study Results

    No Results Posted as of Aug 2, 2022