Corifollitropin Alfa Versus Daily rFSH in the Controlled Ovarian Stimulation of Poor Responders

Study Overview
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Brief Summary
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A randomised, crossover, multicentre, national, clinical trial comparing the efficacy of corifollitropin alfa versus daily recombinant FSH and HMG in the controlled ovarian stimulation of women with a poor ovarian response undergoing IVF treatments. The main objective of this study is comparing the number of oocytes obtained after the follicle puncture when using each of these two stimulation protocols. Only poor responders according to the Bologna criteria will be recruited for this trial. All participants will undergo two stimulation cycles to obtain and accumulate oocytes by vitrification. One of the cycles will be done with the corifollitropin alfa protocol and the other with daily rFSH and HMG, the order of application of these protocols will be randomised (crossover clinical trial) in each patient.

Official Title
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Comparative Study Between the Use of Corifollitropin Alfa and Daily Recombinant FSH in the Controlled Ovarian Stimulation of Poor Responders

Conditions
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Infertility

Intervention / Treatment
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* Drug: Corifollitropin alfa


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Advanced maternal age (≥40 years) A previous poor ovarian response (≤3 oocytes with a conventional stimulation protocol) An abnormal ovarian reserve test (i.e. antral follicle count <5-7 follicles or anti-mullerian hormone level <0.5-1.1 ng/ml)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1<br>First stimulation cycle with corifollitropin alfa (experimental) Second stimulation cycle with rFSH and HMG (active comparator) | Drug: Corifollitropin alfa<br>* One dose of 150 μg of corifollitropin alfa will be administered at day 1 of stimulation. Stimulation will be continued with 250-300 IU/day of rFSH from day 8 forward.<br>* Other names: Elonva;|
| Other: Group 2<br>First stimulation cycle with rFSH and HMG (active comparator) Second stimulation cycle with corifollitropin alfa (experimental) | Drug: Corifollitropin alfa<br>* One dose of 150 μg of corifollitropin alfa will be administered at day 1 of stimulation. Stimulation will be continued with 250-300 IU/day of rFSH from day 8 forward.<br>* Other names: Elonva;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of mature oocytes (metaphase II) | Number of mature oocytes (metaphase II) obtained after the follicle puncture | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of oocytes | Total number of oocytes obtained after the follicle puncture | 1 year | 
| Symptoms associated with the ovarian stimulation protocol | Patients will evaluate their symptoms using a questionnaire. They will score the intensity (from 1 to 10) of each of the following symptoms: pelvic pain, headache, mood swings, nausea, tiredness, breast pain. | 1 year | 
| Patient perception of the stimulation treatment | Patients will evaluate how they have perceived the stimulation treatment using a questionnaire. They will score their comfort (from 1 to 10) with the following aspects of the treatment: treatment administration, number of injections and treatment length. | 1 year | 
| Length of the stimulation treatment | Days of stimulation treatment | 1 year | 
| Number of subcutaneous injections | Number of subcutaneous injections of gonadotropins (corifollitropin alfa, rFSH and HMG) | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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poor ovarian response, controlled ovarian stimulation, randomised clinical trial, corifollitropin alfa, recombinant follicle-stimulating hormone (rFSH), human menopausal gonadotropin (HMG)