Effect of a Higher Than Maximum 450IU Gonadotropin Dose in an In-vitro Fertilization Cycle

March 12, 2014 updated by: Clinique Ovo

Effect of a Higher Than Maximum 450IU Gonadotropin Dose on Patient Outcomes in an In-Vitro Fertilization Setting: a Randomized Controlled Non-infertility Trial

This goal of this study is to evaluate the outcomes from in vitro fertilization cycles where a 450 IU daily dose of gonadotropins is administered compared to those where a 600 IU daily dose is administered for women who are at risk of a poor ovarian response in order to determine if one dose or the other results in improved cycle outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

366

Phase

  • Phase 3

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

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4P 2S4
        • Ovo Fertilité

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 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • RESIDENT OF CANADA
  • Premenopausal
  • Age 40 years or less at the time of enrollment
  • At risk of a poor ovarian response defined as: either <5 oocytes or <8 follicles in a previous cycle, FSH > 10 IU/L, AMH < 1 pg/ml , antral follicle count less or equal to 8 or previous IVF cancellation
  • Primary infertility or secondary
  • Not previously undertaken a cycle that was included in this study

Exclusion Criteria:

  • Simultaneous participation in another clinical trial
  • Body mass index (BMI) > 38 kg/m2
  • Early follicular phase (day 2-4) serum FSH level > 20 mIU/ml
  • Any contraindication to being pregnant and carrying a pregnancy to term
  • Contraindication for the use of Estrace® , Suprefact®, Menopur®, Bravelle®, hCG, and luteal phase support medication
  • Any ovarian or abdominal abnormality that may interfere with adequate transvaginal ultrasound evaluation
  • Administration of any investigational drugs within three months prior to study enrollment
  • Patient not able to communicate adequately with the investigators and to comply with the requirements of the entire study
  • Positive results of screening of either partner for HIV antibodies, Hepatitis B (other than for surface antibodies present after vaccination) or Hepatitis C
  • Unwillingness to give written informed consent

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 450 IU daily dose of gonadotrophin
Drug: menotropins for injection
comparison of different dosages
Other Names:
  • Menopur
Drug: urofollitropin for injection
comparison of different dosages
Other Names:
  • Bravelle
Experimental: 600 IU daily dose of gonadotrophin
Drug: menotropins for injection
comparison of different dosages
Other Names:
  • Menopur
Drug: urofollitropin for injection
comparison of different dosages
Other Names:
  • Bravelle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of metaphase II oocytes retrieved during the course of one treatment cycle
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Implantation rate
Time Frame: 2 years
2 years
Number of follicles recruited per patient during stimulation
Time Frame: 2 years
2 years
Fertilization rate per patient (number of normally fertilized (with 2 pronuclei) oocytes/number of mature oocytes collected)
Time Frame: 2 years
2 years
Embryo cleavage rate per patient (number of divided normally fertilized oocytes/number of normally fertilized oocytes)
Time Frame: 2 years
2 years
Number of embryos available per patient
Time Frame: 2 years
2 years
Number of supernumerary embryos available for cryopreservation per patient
Time Frame: 2 years
2 years
Biochemical pregnancy rate
Time Frame: 2 years
2 years
Clinical pregnancy rate
Time Frame: 2 years
2 years
Rate of multiple gestation
Time Frame: 2 years
2 years
Ongoing pregnancy rate
Time Frame: 2 years
2 years
Live birth rate
Time Frame: 2 years
2 years
rate of occurrence of ovarian hyperstimulation syndrome (OHSS)
Time Frame: 2 years
2 years

Collaborators and Investigators

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

Sponsor

Clinique Ovo

Collaborators

Ferring Pharmaceuticals

Investigators

  • Principal Investigator: Louise Lapensee, MD, Ovo Fertilité
  • Study Director: Jacques Kadoch, MD, OVO Fertilité and OVO R & D

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

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

September 1, 2009

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

September 2, 2009

First Submitted That Met QC Criteria

September 2, 2009

First Posted (Estimate)

September 3, 2009

Study Record Updates

Last Update Posted (Estimate)

March 13, 2014

Last Update Submitted That Met QC Criteria

March 12, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F-GYN-08-02

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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