GnRH Agonist for Luteal Phase Support.

NCT05484193 | Unknown

• 1 other identifier: Synarel fresh LPS
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• pregnancy

  \- positive Bhcg

  2 weeks

Secondary Outcomes (2)

• clinical pregnancy

  5 weeks

• ovarian hyperstimulation syndrome

  5 weeks

Study Arms (2)

GnRH-agonist group

EXPERIMENTAL

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

Progesterone group

ACTIVE COMPARATOR

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

Interventions

GnRH agonist DRUG

GnRH agonist alone for luteal phase support in fresh IVF embryo transfer cycles

Also known as: Synarel

GnRH-agonist group

Progesterone DRUG

vaginal progesterone for luteal phase support

Also known as: Utrogestan

Progesterone group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Study Sites (1)

Shaare Zedek medical Center

Jerusalem, Israel

Location

Related Publications (1)

• Buhbut 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 DERIVED

MeSH Terms

Interventions

Gonadotropin-Releasing Hormone; Nafarelin; Progesterone; Utrogestan

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Progesterone Congeners; Gonadal Steroid Hormones

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2022
• First Posted: August 2, 2022
• Study Start: June 8, 2020
• Primary Completion: April 15, 2022
• Study Completion: January 1, 2023
• Last Updated: August 2, 2022

Record last verified: 2022-07

Locations

IL (1)