NCT06146413

Brief Summary

The aim of this study is to compare the efficacy double trigger \[ co-administration of GnRH agonist with HCG 40 and 34 h prior to ovum pick-up, respectively\] with HCG trigger in inducing oocyte maturation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

November 19, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 24, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

December 30, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

1.2 years

First QC Date

November 19, 2023

Last Update Submit

November 23, 2023

Conditions

Infertility

Keywords

InfertilityIVF-ETHCG triggerDouble 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

    5 weeks after embryo transfer

  • Ongoing Pregnancy Rate

    18 weeks after embryo transfer

Study Arms (2)

Double trigger

EXPERIMENTAL

GnRH agonist ( Triptorelin ) ( 0.2 mg / S.C ) and hCG ( 10000 IU) are administered 40 and 34 h before oocyte retrieval

Drug: Double trigger

HCG trigger

ACTIVE COMPARATOR

HCG ( 100000 IU/ I.M ) is administered 36 h before oocyte retrieval

Drug: HCG trigger

Interventions

Double triggerDRUG

GnRH agonist ( Triptorelin ) ( 0.2 mg / S.C ) and hCG ( 10000 IU) are administered 40 and 34 h before ovum pick-up

Also known as: Augmented trigger
Double trigger
HCG triggerDRUG

hCG ( 10000 IU) is administered 36 h before ovum pick-up

Also known as: Conventional trigger
HCG trigger

Eligibility Criteria

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

You may qualify if:

  • Normoresponders
  • GnRH antagonist cycles

You may not qualify if:

  • BMI more than 35
  • Endometriosis
  • AMH less than 1.1 ng
  • AMH more than 4
  • PCOS
  • Poor responders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bedaya Hospital

Giza, Egypt

Location

Related Publications (1)

  • Haas J, Zilberberg E, Dar S, Kedem A, Machtinger R, Orvieto R. Co-administration of GnRH-agonist and hCG for final oocyte maturation (double trigger) in patients with low number of oocytes retrieved per number of preovulatory follicles--a preliminary report. J Ovarian Res. 2014 Aug 2;7:77. doi: 10.1186/1757-2215-7-77.

    PMID: 25296696BACKGROUND

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Ismail Aboul Foutouh, Prof.

    Cairo University

    STUDY CHAIR

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
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

November 19, 2023

First Posted

November 24, 2023

Study Start

December 30, 2023

Primary Completion

March 30, 2025

Study Completion

December 30, 2025

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations

EG(1)