Optimisation of Follicular Recruitment in IVM Cycles

Study Overview
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Brief Summary
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The study will focus on important aspects related to follicle recruitment using exogenous gonadotropins in patients with polycystic ovaries: Early follicle recruitment in patients with polycystic ovaries using corifollitropin alfa: does administration of this drug result in earlier and higher FSH (follicle stimulating hormone) concentrations above the threshold for follicle recruitment in an IVM (in vitro maturation) cycle preceded by oral contraceptive suppression, in comparison to normal daily administration of rFSH (recombinant follicle stimulating hormone, Puregon)?; The maturation rate of the obtained oocyte-cumulus complexes in standard IVM media registered for clinical use: does stimulation with corifollitropin alfa versus recombinant FSH have an impact on the maturation rate and developmental capacity of the oocytes ?

Official Title
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A Comparison Between Corifollitropin Alfa and Recombinant FSH for Follicular Recruitment in Women With Polycystic Ovaries Who Undergo IVM Treatment

Conditions
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Infertility, Female, Polycystic Ovary Syndrome

Intervention / Treatment
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* Procedure: blood sampling
* Procedure: transvaginal ultrasound scanning
* Procedure: oocyte retrieval for IVM
* Drug: Corifollitropin Alfa
* Drug: Follitropin beta
* Drug: oral contraceptive pill pretreatment (Marvelon)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subfertile patients between 18-36 years old eligible for ART treatment BMI 18-30 Polycystic ovaries (PCO) according to the Rotterdam criteria (at least 12 antral follicles per ovary as observed on a baseline ultrasound scan), with or without hyperandrogenism, with or without oligoamenorrhoea. In other words, patients are eligible if they have PCO morphology. A diagnosis of PCOS (polycystic ovary syndrome) based on Rotterdam criteria is not compulsory. Exclusion Criteria: Antral follicle count (AFC) <24 Anti-müllerian hormone (AMH) <3,25 in non-OCP (oral contraceptive pill) users and <4,00 in current OCP users (using Elecsys platform (Roche Diagnostics)) Couples requesting PGD (preimplantation genetic diagnosis) Non-obstructive azoospermia in the male partner

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 36 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elonva<br>A single injection of 100 microgram corifollitropin alfa. Oocyte retrieval on day five after corifollitropin alfa injection. | Procedure: blood sampling<br>* comparison between corifollitropin alfa and follitropin beta in IVM cycles<br>Procedure: transvaginal ultrasound scanning<br>* comparison between corifollitropin alfa and follitropin beta in IVM cycles<br>Procedure: oocyte retrieval for IVM<br>* comparison between corifollitropin alfa and follitropin beta in IVM cycles<br>Drug: Corifollitropin Alfa<br>* Single injection of 100 micrograms of corifollitropin alfa<br>Drug: oral contraceptive pill pretreatment (Marvelon)<br>* Daily administration of the oral contraceptive pill (Marvelon) for 21 days. Administration of the combined oral contraceptive pill will start after a blood test that demonstrates basal E2 levels and a negative serum hCG level.<br>|
| Active Comparator: Puregon<br>Three daily injections of 150 IU follitropin beta. Oocyte retrieval on day five after the first follitropin beta injection. | Procedure: blood sampling<br>* comparison between corifollitropin alfa and follitropin beta in IVM cycles<br>Procedure: transvaginal ultrasound scanning<br>* comparison between corifollitropin alfa and follitropin beta in IVM cycles<br>Procedure: oocyte retrieval for IVM<br>* comparison between corifollitropin alfa and follitropin beta in IVM cycles<br>Drug: Follitropin beta<br>* Daily injection (three days) of follitropin beta<br>Drug: oral contraceptive pill pretreatment (Marvelon)<br>* Daily administration of the oral contraceptive pill (Marvelon) for 21 days. Administration of the combined oral contraceptive pill will start after a blood test that demonstrates basal E2 levels and a negative serum hCG level.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of COC | Number of oocyte cumulus complexes obtained on the day of oocyte retrieval. | 5 days after the first gonadotropin injection (on the day of oocyte retrieval) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | Clinical pregnancy rate after the first embryo transfer following the IVM cycle | At about 6 - 7 weeks gestation |