Corifollitropin Alfa Followed by Menotropin for Poor Ovarian Responders Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2016-05-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Infertility Poor Ovarian Response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Corifollitropin alfa followed by hpHMG

Group Type EXPERIMENTAL

Corifollitropin alfa

Intervention Type DRUG

Corifollitropin alfa 150μg on day 2 of the menstrual cycle (stimulation day 1)

Ganirelix

Intervention Type DRUG

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

hp HMG

Intervention Type DRUG

hp HMG 300IU/daily from day 9 of the cycle (stimulation day 8)until day of ovulation triggering

recombinant FSH

Group Type ACTIVE_COMPARATOR

recombinant FSH

Intervention Type DRUG

recombinant FSH 300IU/daily from day 2 of the cycle (stimulation day 8)until day of ovulation triggering

Ganirelix

Intervention Type DRUG

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

Interventions

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Corifollitropin alfa

Corifollitropin alfa 150μg on day 2 of the menstrual cycle (stimulation day 1)

Intervention Type DRUG

recombinant FSH

recombinant FSH 300IU/daily from day 2 of the cycle (stimulation day 8)until day of ovulation triggering

Intervention Type DRUG

Ganirelix

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

Intervention Type DRUG

hp HMG

hp HMG 300IU/daily from day 9 of the cycle (stimulation day 8)until day of ovulation triggering

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No