Corifollitropin Alfa Compared to Daily rFSH in Poor Responders Undergoing ICSI

May 13, 2014 updated by: E.M. Kolibianakis, Aristotle University Of Thessaloniki

Corifollitropin Alfa Compared to Daily Rec FSH in Poor Responders Undergoing ICSI Using a GnRH Antagonist Protocol

Corifollitropin alfa has been shown to result in significantly more oocytes compared to daily recombinant follicle stimulating hormone (recFSH) (Devroey et al., 2009), probably due to the higher circulating FSH activity during the first days of stimulation. For this reason, the use of corifollitropin alfa might be beneficial in poor responders in whom the number of oocytes retrieved is crucial for success.

The purpose of this study is to evaluate the effectiveness of corifollitropin alfa treatment compared to daily recFSH in terms of the number of oocytes retrieved in a defined population of poor responder patients undergoing intracytoplasmic sperm injection (ICSI) using gonadotrophin releasing hormone (GnRH) antagonists.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

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

  • Greece
      • Thessaloniki, Greece
        • Unit for Human Reproduction, 1st Dept of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki

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 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Proven poor responders of couples with an indication for COS
  2. ≥ 18 and < 45 years of age
  3. BMI ≥ 18 and ≤ 32 kg/m2
  4. Regular spontaneous menstrual cycle (24-35 days)
  5. Availability of ejaculatory sperm (use of donated and/or cryo-preserved sperm is allowed)

Exclusion Criteria:

  1. PGD or PGS
  2. TESE

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
Experimental: Corifollitropin alfa group

On day 2 of the cycle, a single subcutaneous (SC) dose of 150 μg Corifollitropin alfa (Elonva) will be administered.

GnRH antagonist (Orgalutran) 0.25 mg/day flexible initiation by a follicle of 14mm.

A daily dose of recFSH (450 IU/day) will be used from day 8 of stimulation until the day of hCG, if necessary.

Triggering of final oocyte maturation will be performed using 250 μg of rechCG.
Drug: Corifollitropin alfa
Other Names:
  • Elonva
Active Comparator: rec FSH group

On day 2 of the cycle, daily SC dose of min 450 IU recFSH (Puregon) will be administered.

GnRH antagonist (Orgalutran) 0.25 mg/day , flexible initiation by a follicle of 14mm.

Triggering of final oocyte maturation will be performed using 250 μg of rechCG.
Drug: rFSH
Other Names:
  • Puregon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total number of retrieved oocytes
Time Frame: 36 h after human chorionic gonadotrophin (hCG) administration
36 h after human chorionic gonadotrophin (hCG) administration

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical pregnancy rate (evidence of intrauterine sac with fetal heart activity at 6-8 weeks of gestation)
Time Frame: At 6-8 weeks of gestation
At 6-8 weeks of gestation
Number of embryos transferred
Time Frame: 2 days following oocyte retrieval
2 days following oocyte retrieval

Collaborators and Investigators

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

Sponsor

Aristotle University Of Thessaloniki

Investigators

  • Principal Investigator: Efstratios M Kolibianakis, MD, MSc, PhD, Unit for Human Reproduction, 1st Dept. of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki

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)

March 1, 2014

Study Registration Dates

First Submitted

December 18, 2013

First Submitted That Met QC Criteria

January 24, 2014

First Posted (Estimate)

January 28, 2014

Study Record Updates

Last Update Posted (Estimate)

May 14, 2014

Last Update Submitted That Met QC Criteria

May 13, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHR-11

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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