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Trial · Interventional

Status unknownNot applicableRegistry data

GnRH Agonist for Luteal Phase Support.

NCTNCT05484193 (opens ClinicalTrials.gov in a new tab)Other idSynarel fresh LPS
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Not applicable
Enrollment
150 participants (actual)
Sponsor
Shaare Zedek Medical Center · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Israel

Start
8 Jun 2020
Primary completion
15 Apr 2022
Completion
1 Jan 2023 (estimated)
First posted
2 Aug 2022
Last update posted
2 Aug 2022
Conditions
Use of GnRH Agonist Alone for Luteal Phase Support in Fresh IVF Cycles

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20202021202220232024
  1. N/A

    GnRH Agonist for Luteal Phase Support.

    NCT05484193

    8 Jun 2020 to est. 1 Jan 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • GnRH agonistDrug
  • ProgesteroneDrug

Arms2

  • 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

  • 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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. pregnancy

    Time frame · 2 weeks

    Registry description

    \- positive Bhcg

Secondary outcomes(2)

  1. clinical pregnancy

    Time frame · 5 weeks

    Registry description

    gestational sac with heartbeat

  2. ovarian hyperstimulation syndrome

    Time frame · 5 weeks

    Registry description

    early and late

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedBuhbut E, Nabulsi R, Avigdor G, Ben-Ami I. Comparison of pregnancy rates in antagonist cycles after luteal support with GnRH-agonist versus progesterone: prospective randomized study. Arch Gynecol Obstet. 2023 Jul;308(1):255-263. doi: 10.1007/s00404-023-07017-5. Epub 2023 Apr 25. PMID 37186265

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 45 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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. \-

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