Trial Comparing hCG Triggering Versus hCG Associated With GnRH Agonist

February 3, 2015 updated by: Dr. Decleer Wim, AZ Jan Palfijn Gent

Randomised Controlled Trial Comparing hCG Triggering Versus hCG Associated With GnRH Agonist

The purpose of this study is to see whether patients triggered with only human Chorion Gonadotropin (hCG) have higher number of Metaphase II oocytes (MII) and implantation rate than patients triggered with hCG combined with Gonadotropin Releasing Hormone (GnRH) agonist.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • Belgium
    • Oost-vlaanderen
      • Gent, Oost-vlaanderen, Belgium, 9000
        • A Z Jan Palfijn

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

No older than 38 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Intra-cytoplasmic sperm injection (ICSI) patients below 38 years
  • 1,2 or 3 rd IVF-cycle

Exclusion Criteria:

  • polycystic ovary syndrome (PCOS) patients
  • patients with endocrinological diseases or problems

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: hCG
5000 IU Pregnyl SC
Drug: pregnyl
5000 IU SC
ACTIVE_COMPARATOR: hCG and GnRH agonist
5000 IU Pregnyl SC + 0.2 mg Decapeptyl daily SC
Drug: pregnyl
5000 IU SC
Drug: Decapeptyl Daily
Decapeptyl 0.2 mg SC once 1day
Other Names:
  • Gonapeptyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MII Oocytes
Time Frame: 3 weeks
the number of mature oocytes retrieved
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy Rate
Time Frame: 12 weeks
the number of pregnancies obtained, wich still is the most important issue for the patients
12 weeks
Patients With Cryopreserved Embryos
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

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

Sponsor

AZ Jan Palfijn Gent

Collaborators

Onze Lieve Vrouw Hospital

Investigators

  • Principal Investigator: Wim Decleer, gynacologist, IVF Centrum Jan Palfijn Gent

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

November 1, 2011

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

May 4, 2012

First Submitted That Met QC Criteria

May 24, 2012

First Posted (ESTIMATE)

May 30, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

February 19, 2015

Last Update Submitted That Met QC Criteria

February 3, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dr. Decleer Wim

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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