Corifollitropin Alfa Followed by Menotropin for Poor Ovarian Responders Trial (COMPORT)

June 21, 2016 updated by: Nikolaos P. Polyzos, Universitair Ziekenhuis Brussel

Corifollitropin Alfa Followed by Hp-HMG Versus Recombinant FSH in Young Poor Ovarian Responders. A Multicentre Randomized Controlled Clinical Trial

In combination with the existing literature, previous work indicates that 1) women with poor ovarian response fulfilling the "Bologna criteria" have very low pregnancy rates, irrespective of age 2) current treatment protocols demonstrate ongoing pregnancy rates that do not exceed 8.5% and 3) corifollitropin alfa followed by hpHMG might increase ongoing pregnancy rates in young patients (<40years old) fulfilling the criteria. These findings provide a strong rationale for a definitive large RCT. The COMPORT study will provide conclusive evidence regarding the superiority or not of this novel protocol with corifollitropin alfa followed by hpHMG for the treatment of young poor ovarian responders fulfilling the Bologna criteria.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Recently, the European Society of Human Reproduction and Embryology developed a new definition in order to select patients suitable for inclusion in future clinical trials as poor ovarian responders, the so-called "Bologna criteria". However, a limited number of studies has been published to date including patients with poor ovarian response according to the "Bologna criteria", whereas no randomized trial is published or ongoing for this population.

Preliminary reports in "Bologna poor responders" highlight the limited prospects for these women. Natural cycle IVF has been shown to result in disappointingly low live birth rates, regardless of patients' age and ovarian stimulation with widely accepted treatment modalities, e.g. short agonist protocol, did not appear demonstrate substantial benefits.

Nonetheless, despite the disappointing results from the vast majority of the preliminary studies in this population, a recent pilot study by our group has shown that a specific protocol may indeed be a promising option for women of younger age fulfilling the "Bologna criteria". Corifollitropin alfa followed by highly purified hMG in an antagonist protocol demonstrated an ongoing pregnancy rate of 28% in women <40years, strongly suggesting the conduction of a future randomized trial testing this novel treatment protocol

Study Type

Interventional

Enrollment (Actual)

150

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

  • Belgium
      • Brussels, Belgium, 1090
        • Universitair Ziekenhuis Brussel
  • Vietnam
      • Ho Chi Minh City, Vietnam
        • University of Medicine and Pharmacy of Ho Chi Minh City

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 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age less than 40 years
  • Fulfillment of the "Bologna criteria" for poor ovarian response.

Based on inclusion criteria two patients' categories are eligible:

  1. Women < 40 years old AND ≤3 oocytes in one of the previous cycles AND (Antral follicle count <7 or antimullerian hormone serum values <1.1 ng/ml)
  2. Women <40 years old and ≤3 oocytes in two the previous cycles with maximum ovarian stimulation

In addition women less than 40 years old will be considered eligible if they had undergone previous ovarian surgery or chemotherapy (risk factors for poor ovarian response) and have an AMH<1.1ng/ml or an AFC<7, as suggested by the Bologna criteria

Exclusion Criteria:

  • Uterine abnormalities
  • Recent history of any current untreated endocrine abnormality
  • Unilateral or bilateral hydrosalpinx (visible on transvaginal ultrasound, unless clipped)
  • Contraindications for the use of gonadotropins
  • Recent history of severe disease requiring regular treatment

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: recombinant FSH
Drug: Ganirelix
Ganirelix 0.25mg/daily from day 7 of the cycle(stimulation day 6) until day of ovulation triggering
Drug: recombinant FSH
recombinant FSH 300IU/daily from day 2 of the cycle (stimulation day 8)until day of ovulation triggering
Experimental: Corifollitropin alfa followed by hpHMG
Drug: Corifollitropin alfa
Corifollitropin alfa 150μg on day 2 of the menstrual cycle (stimulation day 1)
Drug: Ganirelix
Ganirelix 0.25mg/daily from day 7 of the cycle(stimulation day 6) until day of ovulation triggering
Drug: hp HMG
hp HMG 300IU/daily from day 9 of the cycle (stimulation day 8)until day of ovulation triggering

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ongoing pregnancy
Time Frame: 9-10 weeks of gestation
The presence of intrauterine gestational sac with an embryonic pole demonstrating cardiac activity at 9-10 weeks of gestation.
9-10 weeks of gestation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical pregnancy
Time Frame: 2 weeks after embryo transfer
Positive pregnancy test 2 weeks after embryo transfer
2 weeks after embryo transfer
Number of oocytes retrieved
Time Frame: 9 -20 days from initiation of ovarian stimulation
The outcome will be evaluated on the day of oocyte retrieval
9 -20 days from initiation of ovarian stimulation
Clinical pregnancy
Time Frame: 7 weeks of gestation
The presence of intrauterine gestational sac at 7 weeks of gestation
7 weeks of gestation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of cycles reaching the stage of embryo transfer
Time Frame: 9 -20 days from initiation of ovarian stimulation
The outcome will be evaluated 3 days after oocyte retrieval
9 -20 days from initiation of ovarian stimulation
Cycle cancellation due to poor ovarian response
Time Frame: Day 8-10 of ovarian stimulation
Number of cycles cancelled due to monofollicular or no follicular development
Day 8-10 of ovarian stimulation
Number and quality of embryos
Time Frame: Day of embryo transfer
3 days after oocyte retrieval
Day of embryo transfer
Number of cycles with frozen supernumerary embryos
Time Frame: 9 -20 days from initiation of ovarian stimulation
The outcome will be evaluated 5 days after oocyte retrieval or 2-3 days after embryo transfer in case of an embryo transfer
9 -20 days from initiation of ovarian stimulation
Endocrine parameters (LH,FSH, E2, Progesterone) during ovarian stimulation
Time Frame: Days 1,6,8,10 of stimulation and day of ovulation triggering
Days 1,6,8,10 of stimulation and day of ovulation triggering
Cycle cancellation due to serious adverse effects of medication
Time Frame: 20-25 days after initiation of stimulation
20-25 days after the initiation of ovarian stimulation all patients (cycles) will be monitored for the occurence of any adverse effect and cycle cancellation(during ovarian stimulation) due to a serious adverse effect from medication
20-25 days after initiation of stimulation

Collaborators and Investigators

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

Sponsor

Universitair Ziekenhuis Brussel

Collaborators

University of Medicine and Pharmacy at Ho Chi Minh City

Investigators

  • Principal Investigator: Nikolaos P Polyzos, MD PhD, Universitair Ziekenhuis Brussel

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

March 1, 2013

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

March 16, 2013

First Submitted That Met QC Criteria

March 19, 2013

First Posted (Estimate)

March 22, 2013

Study Record Updates

Last Update Posted (Estimate)

June 23, 2016

Last Update Submitted That Met QC Criteria

June 21, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 143201316398
  • 2013-000583-29 (EudraCT Number)

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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