NCT07569302

Brief Summary

The aim of this randomized controlled study is to compare the efficacy of a modified dual trigger protocol \[a single bolos of HCG combined with two successive doses of a GnRH agonist \] with HCG \[a single bolos administered 36 hours before oocyte retrieval \] in triggering ovulation in normo-responders undergoing ovarian stimulation using the antagonist protocol.

Trial Health

63
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Trial Health Score

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

Enrollment
196

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 (IVF Patients)

Keywords

InfertilityIVF-ETNormo-respondersGnRH agonistHCG

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)

Modified dual trigger group

EXPERIMENTAL

HCG is administered 36 hours before ovum pickup and two successive doses of GnRH are administered 36 and 24 hours before ovum pickup.

Drug: Modified dual trigger

HCG group

ACTIVE COMPARATOR

A single dose of HCG is administered 36 hours before oocyte retrieval

Drug: HCG

Interventions

HCGDRUG

HCG (10000 IU/IM ) is administered 36 hours before ovum pickup.

HCG group
Modified dual triggerDRUG

HCG (10000 IU /IM) and triptorelin (0.2 mg/S.C) are administered 36 hours before ovum pickup . Moreover, 0.1mg of triptorelin is administered 24 h prior to ovum pick-up.

Modified dual trigger group

Eligibility Criteria

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

You may qualify if:

  • GnRH antagonist IVF cycle
  • Normo-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, 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)