Continuous Double Ovarian Stimulation.

Study Overview
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Brief Summary
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To evaluate the efficacy of the weekly use of corifollitropin alfa in double ovarian stimulation process and to compare it to the conventional protocol with daily medication administration.

Detailed Description
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The purpose of this pilot study is to evaluate the efficacy of the weekly use of corifollitropin alfa in terms of ovarian stimulation results and its biological outcomes (total number of oocytes retrieved) in case of ovarian stimulation cycles in double stimulation modality (DUOSTIM) and in comparison with the conventional DUOSTIM protocol: daily administration of gonadotropins.

Official Title
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Continuous Ovarian Stimulation in DUOSTIM Cycles.

Conditions
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Fertility Issues

Intervention / Treatment
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* Drug: Corifollitropin Alfa
* Drug: Follitropin Alfa
* Drug: Follitropin Alfa Biosimilar
* Drug: Urinary Human follicle stimulating hormone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with indication for DUOSTIM protocol Maximum age of 43 years (up to one day before their 44th birthday) at the beginning of the stimulation process. Ability to participate and comply with the study protocol. To have given written consent Exclusion Criteria: Finding of ovarian pathology at the time of initiation of stimulation: e.g. ovarian cysts. Concurrent participation in another study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 43 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Patients to carry out an experimental double ovarian stimulation and to receive 4 weekly injections of Corifollitropin alfa. Prospective group. | Drug: Corifollitropin Alfa<br>* 150 micrograms per dose<br>* Other names: 4 Weekly Corifollitropin Alfa injections;|
| Active Comparator: Control group<br>Patients to carry out a conventional double ovarian stimulation and to receive daily injections of gonadotropins. Retrospective group (data retrieved from strictly selected treatments carried out in our institution within the 24 months prior to the inclusion of the first patient in the study group and according to the standard guideline of the clinic). | Drug: Follitropin Alfa<br>* Variable dose.<br>* Other names: Daily injections of gonadotropins;Drug: Follitropin Alfa Biosimilar<br>* Variable dose.<br>* Other names: Daily injections of gonadotropins;Drug: Urinary Human follicle stimulating hormone<br>* Variable dose.<br>* Other names: Daily injections of gonadotropins;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of retrieved oocytes - study group | To investigate the total number of oocytes retrieved through ovarian stimulation in double ovarian stimulation (DUOSTIM) cycles utilizing weekly subcutaneous injections of Corifollitropin alfa during DUOSTIM stimulation | Through study completion, an average of four months | 
| number of retrieved oocytes - comparison | To compare the total number of oocytes obtained in the study group with the outcomes of historical data collected from conventional DUOSTIM cycles that employed the conventional protocol (consisting of daily subcutaneous injections of gonadotropins). | Through study completion, an average of four months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of MII oocytes - comparison | To assess whether there exist any differences between the two groups with respect to the rate of metaphase II (MII) oocytes. | Through study completion, an average of four months | 
| duration of DUOSTIM cycle - comparison | To assess whether there are differences between the two groups concerning the duration of stimulation. | Through study completion, an average of four months | 
| fertilization rate - comparison | To assess whether there are differences between both groups regarding the fertilization rate. | Through study completion, an average of four months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OVARIAN STIMULATION