In Vitro Maturation (IVM) for Polycystic Ovary Syndrome (PCOS)

Study Overview
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Brief Summary
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This pilot study will be a prospective investigation to study the efficacy and safety of In-Vitro Maturation (IVM) for women with Polycystic Ovarian Syndrome (PCOS). There will be 10 subjects total in this Study. There will be no blinding to treatment. In-Vitro Maturation will provide a viable, safe option for women with PCOS attempting pregnancy through the use of Assisted Reproductive Technology (ART).

Official Title
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In Vitro Maturation for Polycystic Ovary Syndrome (PCOS)- A Pilot Study

Conditions
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Polycystic Ovarian Syndrome

Intervention / Treatment
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* Other: IVM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria 10 women between the ages of 18-34 inclusive at time of signing Informed Consent Form. A diagnosis of PCOS by their primary MD An Antral Follicular Count (AFC) of > 12 on one ovary on at least one occasion A day 3 FSH level of <8 IU/mL In good general health off of current medications which may confound response to study medications. Desire to seek pregnancy actively during the study period by IVF-ICSI. A normal uterine cavity must have been confirmed by either hydrosonogram or hysteroscopy within two years of entering the study. Male partner able to provide adequate semen sample by ejaculation (no TESE) Exclusion Criteria Current pregnancy Patients with uncorrected thyroid disease (defined as TSH < 0.2 mIU/ML or >5.5 mIU/mL). A normal level within the last year is adequate for entry. Patients with poorly controlled diabetes (HgB A1C over 8.0 ng/dL). Patients enrolled simultaneously into other investigative studies that require medications, proscribe the study medications, limit intercourse, or otherwise prevent compliance with the protocol. Patients with significant anemia (Hemoglobin < 10 mg/dL). Patients enrolled simultaneously into other investigative studies that would interfere with this research study. have any contraindications to using birth control pills (oral contraceptives) as determined by the attending physician (e.g. history of thromboembolism or estrogen-dependent malignancy, such as breast cancer, etc.) -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 34 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: In Vitro Maturation (IVM)<br> | Other: IVM<br>* all patients in this pilot study will undergo IVM. IVM involves immature eggs being retrieved and matured in the laboratory.After maturation they are fertilized like is done in a typical IVF cycle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Biochemical Pregnancy (defined as a rising Beta-HCG level). |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of immature oocytes retrieved |  | 6 months | 
| rates of maturation and fertilization |  | 6 months | 
| Incidence of Ovarian Hyperstimulation Syndrome (OHSS) |  | 6 months | 
| live births |  | 1 1/2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCOS, IVM, Polycystic ovarian syndrome, In Vitro Maturation, IVF