Endometrial Advancement After Rec or u-HCG Triggering

December 1, 2015 updated by: Papanikolaou Evangelos, Universitair Ziekenhuis Brussel
The purpose of this study is to investigate any potential advantages of replacing human chorionic gonadotropin (uhCG) with recombinant human chorionic gonadotropin (recHCG) for final oocyte maturation with regard to Ovarian hyperstimulation syndrome (OHSS)pathophysiology, endometrium receptivity and embryo quality and clinical pregnancy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Biopsies of endometrium were taken in different groups Pregnancy rates were compared among defferent groups

Study Type

Interventional

Enrollment (Actual)

130

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
    • Jette
      • Brussels, Jette, Belgium, 1090
        • Centre for Reproductive Medicine, UZ Brussel

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

20 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Less than 36 years old
  • Male or tubal infertility
  • FSH<12 on day 3

Exclusion Criteria:

  • Endometriosis stage 3 & 4

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
Active Comparator: o Group A=uHCG ovul trig
HCG for triggering
Drug: 10000 IU urinary HCG
bolus 10000 units for ovulation triggering
Other Names:
  • Pregnyl
Experimental: o Group B=recHCG ovul trig
recombinant HCG for triggering
Drug: 250 mcg recombinant HCG
bolus 250 mcg for ovulation triggering in IVF patients
Other Names:
  • Ovitrelle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
endometrium histology on the day of OPU
Time Frame: day of oocytre pick up
day of oocytre pick up

Secondary Outcome Measures

Outcome Measure
Time Frame
pregnancy rate
Time Frame: 14 days after oocyte pick up
14 days after oocyte pick up

Collaborators and Investigators

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

Sponsor

Universitair Ziekenhuis Brussel

Collaborators

Merck Serono International SA

Investigators

  • Study Director: Paul Devroey, Professor, Professor or OB-GYN

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.

Helpful Links

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

August 1, 2005

Primary Completion (Actual)

December 1, 2006

Study Completion

December 1, 2008

Study Registration Dates

First Submitted

August 5, 2009

First Submitted That Met QC Criteria

August 5, 2009

First Posted (Estimate)

August 6, 2009

Study Record Updates

Last Update Posted (Estimate)

December 3, 2015

Last Update Submitted That Met QC Criteria

December 1, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • recHCG001

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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