Corifollitropin Alfa Versus Recombinant Follicle Stimulating Hormone (FSH) in Ovarian Stimulation of Women Undergoing in Vitro Fertilisation

March 15, 2021 updated by: Siristatidis Charalampos, MD, PhD, National and Kapodistrian University of Athens
The use of corifollitropin alfa is superior in terms of pregnancy outcome parameters as compared to recombinant follicle stimulating hormone (FSH) during ovarian stimulation protocols in women undergoing in vitro fertilisation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 2
  • Phase 1

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

  • Greece
    • Chaidari
      • Athens, Chaidari, Greece, 12462
        • 3rd Department of Obstetrics and Gynecology, Assisted Reproduction Unit
      • Athens, Chaidari, Greece, 12642
        • Attikon University Hospital

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

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women aged 18-36 years old with a body weight of more than 60 kg up to 90 kg
  • BMI of 18-32 kg/m2
  • Menstrual cycle length of 23-35 days
  • An indication for controlled ovarian stimulation for IVF or ICSI

Exclusion Criteria:

  • history of an endocrine abnormality
  • abnormal outcome of blood biochemistry or hematology
  • abnormal cervical smear
  • chronic disease
  • uterine pathology that interfering with the COS treatment (e.g. fibroids ≥ 5 cm)

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: corifollitropin alfa
Drug: corifollitropin alfa
100 microg for a group of women weighing 60 kg
Active Comparator: recombinant follicle stimulating hormone (FSH)
150-300 IU of FSH for ovarian stimulation in women undergoing IVF
Drug: recombinant follicle stimulating hormone (FSH)
150-300 IU of the drug daily from day 2 of the menstrual cycle until more than 2 follicles are >18mm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
no of oocytes (>2 between groups)
Time Frame: at egg recovery, through study completion, an average of 2 years
at egg recovery, through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
miscarriage rate
Time Frame: through study completion, an average of 2 years
through study completion, an average of 2 years
live birth rate
Time Frame: through study completion, an average of 2 years
through study completion, an average of 2 years
Clinical pregnancy rate cancellation rate miscarriage rate ectopic pregnancy rate
Time Frame: 3 weeks after embryo transfer
The presence of fetal heart at transvaginal ultrasound at 6+2 gestational weeks
3 weeks after embryo transfer
Ongoing pregnancy rate
Time Frame: 12 weeks after embryo transfer
The presence of fetal heart at ultrasound after 12 gestational weeks
12 weeks after embryo transfer

Collaborators and Investigators

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

Sponsor

National and Kapodistrian University of Athens

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

January 1, 2011

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

March 8, 2011

First Submitted That Met QC Criteria

March 21, 2011

First Posted (Estimate)

March 22, 2011

Study Record Updates

Last Update Posted (Actual)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 15, 2021

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1234560

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We will be happy to share the data

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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