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

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ClinicalTrials.gov Identifier: NCT01816321
Recruitment Status : Completed
First Posted : March 22, 2013
Last Update Posted : June 23, 2016
Sponsor:
Collaborator:
University of Medicine and Pharmacy at Ho Chi Minh City
Information provided by (Responsible Party):
Nikolaos P. Polyzos, Universitair Ziekenhuis Brussel

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Infertility Poor Ovarian Response Drug: Corifollitropin alfa Drug: recombinant FSH Drug: Ganirelix Drug: hp HMG Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Corifollitropin Alfa Followed by Hp-HMG Versus Recombinant FSH in Young Poor Ovarian Responders. A Multicentre Randomized Controlled Clinical Trial
Study Start Date : March 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Arms and Interventions
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Arm Intervention/treatment
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
Active Comparator: recombinant FSH Drug: recombinant FSH
recombinant FSH 300IU/daily from day 2 of the cycle (stimulation day 8)until day of ovulation triggering

Drug: Ganirelix
Ganirelix 0.25mg/daily from day 7 of the cycle(stimulation day 6) until day of ovulation triggering


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Clinical pregnancy [ Time Frame: 7 weeks of gestation ]
    The presence of intrauterine gestational sac at 7 weeks of gestation

  2. Biochemical pregnancy [ Time Frame: 2 weeks after embryo transfer ]
    Positive pregnancy test 2 weeks after embryo transfer

  3. 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


Other Outcome Measures:
  1. 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

  2. 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

  3. Number and quality of embryos [ Time Frame: Day of embryo transfer ]
    3 days after oocyte retrieval

  4. 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

  5. Endocrine parameters (LH,FSH, E2, Progesterone) during ovarian stimulation [ Time Frame: Days 1,6,8,10 of stimulation and day of ovulation triggering ]
  6. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01816321


Locations
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Belgium
Universitair Ziekenhuis Brussel
Brussels, Belgium, 1090
Vietnam
University of Medicine and Pharmacy of Ho Chi Minh City
Ho Chi Minh City, Vietnam
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
University of Medicine and Pharmacy at Ho Chi Minh City
Investigators
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Principal Investigator: Nikolaos P Polyzos, MD PhD Universitair Ziekenhuis Brussel
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Nikolaos P. Polyzos, Principal Investigator, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT01816321    
Other Study ID Numbers: 143201316398
2013-000583-29 ( EudraCT Number )
First Posted: March 22, 2013    Key Record Dates
Last Update Posted: June 23, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Infertility
Ganirelix
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs