Triggering Oocyte Maturation in Normoresponders Using Double Trigger or HCG Trigger (Doubtrig)

November 23, 2023 updated by: Usama M.Fouda, Bedaya Hospital

Triggering Oocyte Maturation in Normoresponders Using Double Trigger or HCG Trigger . A Randomized Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Several studies revealed that the double trigger regimen was effective in the treatment of patients with a history of immature oocytes retrieved or with suboptimal oocytes yield.

The investigators designed this randomized controlled trial to compare the efficacy double trigger with HCG trigger in inducing oocyte maturation.in normoreponders undergoing IVF-ET

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Normoresponders
  • GnRH antagonist cycles

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Double trigger
GnRH agonist ( Triptorelin ) ( 0.2 mg / S.C ) and hCG ( 10000 IU) are administered 40 and 34 h before oocyte retrieval
Drug: Double trigger
GnRH agonist ( Triptorelin ) ( 0.2 mg / S.C ) and hCG ( 10000 IU) are administered 40 and 34 h before ovum pick-up
Other Names:
  • Augmented trigger
Active Comparator: HCG trigger
HCG ( 100000 IU/ I.M ) is administered 36 h before oocyte retrieval
Drug: HCG trigger
hCG ( 10000 IU) is administered 36 h before ovum pick-up
Other Names:
  • Conventional trigger

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metaphase-II oocytes rate
Time Frame: Ten to fifteen days after starting ovarian stimulation
Number of MII oocyte/ number of cumulus oocyte complex
Ten to fifteen days after starting ovarian stimulation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy rate
Time Frame: 5 weeks after embryo transfer
Presence of intrauterine gestational sac detected by transvaginal ultrasound
5 weeks after embryo transfer
Ongoing Pregnancy Rate
Time Frame: 18 weeks after embryo transfer
Pregnancies continued beyond 20 weeks gestation
18 weeks after embryo transfer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bedaya Hospital

Investigators

  • Study Chair: Ismail Aboul Foutouh, Prof., Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 30, 2023

Primary Completion (Estimated)

March 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

November 19, 2023

First Submitted That Met QC Criteria

November 19, 2023

First Posted (Actual)

November 24, 2023

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 23, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Double trigger in IVF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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