NCT07569289

Brief Summary

The aim of this randomized controlled study is to compare the efficacy of double trigger protocol \[ the co-administration of GnRH agonist with HCG ( 38 - 39 and 35 - 36 h prior to ovum pick-up, respectively \] with HCG in triggering ovulation in patients with expected poor response to ovarian stimulation

Trial Health

63
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Trial Health Score

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

Enrollment
164

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

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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

Infertility

Keywords

InfertilityPoor respondersIVF-ETHCGGnRH agonistDouble trigger

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)

Double trigger

EXPERIMENTAL

GnRH agonist is administered 38 - 39 hours prior to ovum pick-up and HCG is administered 35 - 36 hours prior to ovum pick-up, respectively.

Drug: Double trigger

HCG trigger

ACTIVE COMPARATOR

HCG is administered 35 - 36 h prior to ovum pick-up

Drug: HCG trigger

Interventions

Double triggerDRUG

Triptorelin (0.2 mg/S.C ) and HCG (10000 IU/I.M) are administered 38 to 39 h and 35 to 36 h prior to ovum pick-up., respectively.

Double trigger
HCG triggerDRUG

HCG (10000 IU/I.M) is administered 35 to 36 h prior to ovum pick-up.

HCG trigger

Eligibility Criteria

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

You may qualify if:

  • POSEIDON group 3 and 4
  • GnRH antagonist IVF cycle

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, Giza Governorate, 3753303, Egypt

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Central Study Contacts

Usama M Fouda, Prof.

CONTACT

+201095401375umfrfouda@yahoo.com

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

EG(1)