NCT07569315

Brief Summary

The aim of this randomized controlled study is to compare the efficacy of three successive doses of a GnRH agonist ( administered 36 , 24 and 12 hours before oocyte retrieval ) with a single dose of a GnRH agonist ( administered 36 hours before oocyte retrieval ) in triggering ovulation in hyper-responders

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P75+ for phase_2

Timeline
22mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 6, 2026

Completed
26 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

1.5 years

First QC Date

April 29, 2026

Last Update Submit

April 29, 2026

Conditions

Keywords

InfertilityGnRH agonist triggerIVF-ETHyper-respondersPCOS

Outcome Measures

Primary Outcomes (1)

  • Metaphase-II oocytes rate

    Number of MII oocyte/ number of cumulus oocyte complex

    Ten to fifteen days after starting ovarian stimulation

Secondary Outcomes (2)

  • Clinical pregnancy rate

    Five weeks after embryo transfer

  • Ongoing pregnancy Rate

    Eighteen weeks after embryo transfer

Study Arms (2)

Successive doses GnRH agonist

EXPERIMENTAL

Three successive doses of GnRH agonist are administered 36 , 24 and 12 hours before oocyte retrieval

Drug: Successive doses GnRH agonist

Single dose GnRH agonist

ACTIVE COMPARATOR

A single dose of GnRH agonist is administered 36 hours before oocyte retrieval

Drug: Single dose GnRH agonist

Interventions

GnRH agonist ( Triptorelin ) ( 0.2 mg / S.C ) is administered 36 hours before ovum pickup. Two additional doses of triptorelin ( 0.1 mg / S.C ) are administered subcutaneously 12 and 24 hours after the first dose of GnRH agonist.

Successive doses GnRH agonist

GnRH agonist ( Triptorelin ) ( 0.2 mg / S.C ) is administered 36 hours before ovum pickup.

Single dose GnRH agonist

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • GnRH antagonist IVF cycle
  • Hyper-responders to induction of ovulation

You may not qualify if:

  • Hypogonadotrophic hypogonadism
  • Endometriosis
  • History of recurrent abortion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bedaya Hospital

Giza, Egypt

Location

Related Publications (1)

  • Hashemi SH, Hafezi M, Arabipoor A, Zareei M, Vesali S, Eftekhari-Yazdi P. Can We Harvest More Mature Oocytes by Repeating Gonadotropin-Releasing Hormone Agonist Doses in Polycystic Ovarian Syndrome Patients at Risk of OHSS in Antagonist Cycles? A Randomised Clinical Trial. Int J Fertil Steril. 2024 Jul 13;18(Suppl 1):48-54. doi: 10.22074/ijfs.2023.2008905.1513.

    PMID: 39033370BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

Gonadotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Central Study Contacts

Usama M. Fouda, Prof.

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2026

First Posted

May 6, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

April 1, 2028

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations