Low Dose hCG in the Late Follicular Phase

October 8, 2010 updated by: Universitair Ziekenhuis Brussel

Among ICSI Patients Undergoing Antagonist Protocols With Recombinant FSH, Does Replacement of Recombinant FSH by 200 IU of hCG in the Late Follicular Phase Compared With Continuing Recombinant FSH, Result in a Similar Number of Oocytes?

In this study,the investigators compared two protocols for controlled ovarian hyperstimulation in infertility patients requiring IVF. In the control group, the patient undergoes a standard antagonist protocol. In the study group, the administration of gonadotropins is stopped in the late follicular phase and replaced by low dose human chorionic gonadotropins. The primary endpoint of the study is the number of oocytes retrieved in both groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

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
    • Brussels
      • Laarbeeklaan 101, Brussels, Belgium, 1090
        • 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

18 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • < 36 years on day of randomisation
  • FSH < 12 in the early follicular phase
  • Normal ultrasound scan
  • BMI between 18 and 29 (both inclusive)
  • Randomisation at outpatient clinic

Exclusion Criteria:

  • Endometriosis ≥ grade 3
  • PCO syndrome
  • Poor responder
  • Endocrine or metabolic abnormalities

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: A
Patients undergo a standard antagonist protocol for in-vitro fertilisation, and are stimulated with recombinant gonadotropins.
Drug: recombinant gonadotropins
200 IU per day during controlled ovarian stimulation
Other Names:
  • Puregon, NV Organon, Oss, The Netherlands
Experimental: B
Patients are undergo an antagonist protocol for in-vitro fertilisation and are stimulated with recombinant gonadotropins. When the patient has an estradiol value of 600 ng/L or more and when the patient has at least 6 follicles of 12 mm, the administration of gonadotropins is stopped and replaced by low dose human chorionic gonadotropins.
Drug: human chorionic gonadotropin
hCG 200IU in the late follicular phase
Other Names:
  • Pregnyl, NV Organon, Oss, The Netherlands

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of oocytes in both treatment groups
Time Frame: up to 9 months
up to 9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of stimulation in both treatment groups, amount of gonadotropins consumed in each treatment group
Time Frame: up to 9 months
up to 9 months

Collaborators and Investigators

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

Sponsor

Universitair Ziekenhuis Brussel

Investigators

  • Principal Investigator: Christophe Blockeel, MD, UZ Brussel, Centre for Reproductive Medicine, Brussels

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

September 1, 2007

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

September 9, 2008

First Submitted That Met QC Criteria

September 9, 2008

First Posted (Estimate)

September 10, 2008

Study Record Updates

Last Update Posted (Estimate)

October 11, 2010

Last Update Submitted That Met QC Criteria

October 8, 2010

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC REF 2006-157

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.

Clinical Trials on Infertility

Clinical Trials on recombinant gonadotropins

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe