In Vitro Maturation (IVM) of Human Oocytes

Study Overview
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Brief Summary
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The objectives of this study are to evaluate the clinical efficacy of Natural in vitro Fertilization and in vitro maturation.

Detailed Description
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Collection of one mature egg from a follicle in the ovary without gonadotropin medications (natural cycle IVF) results in low pregnancy rates. One way to improve natural cycle IVF is to combine this procedure with the removal of immature eggs from the ovary and mature these eggs in the laboratory ( in vitro maturation-IVM). The in vitro mature eggs are fertilized and the resultant embryos are cultured using conventional IVF techniques.

Official Title
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In Vitro Maturation (IVM) of Human Oocytes

Conditions
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Infertility

Intervention / Treatment
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* Procedure: in vitro maturation
* Procedure: Polar Body Biopsy with preimplantation genetic screening


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Each subject must be female. Each subject must have an indication for COH and IVF with or without ICSI. Each subject must be willing and able to provide written informed consent for the trial Each subject must be 25 to ≤42 years of age at the time of signing informed consent. Each subject must have a normal cervical smear result (no atypical or abnormal cells, or in case of atypical squamous or glandular cells, no signs of malignancy; corresponding to Papanicolaou [PAP] I or II) obtained within 12 months prior to signing informed consent must be available Exclusion Criteria: Subject with premature ovarian failure Subject with endocrine abnormalities such as hyperprolactinaemia or thyroid dysfunction Subject with malformation or absence of uterus Subject has tested positive for Human Immunodeficiency Virus (HIV) or Hepatitis B (by local laboratory; results obtained within 1 year prior to signing ICF are considered valid). Subject with contraindication or allergy/hypersensitivity to hCG, estrogen and progesterone

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 42 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<br>in vitro maturation of immature oocytes | Procedure: in vitro maturation<br>* Maturation of immature oocytes in the laboratory following oocyte retrieval<br>Procedure: Polar Body Biopsy with preimplantation genetic screening<br>* Polar body biopsy is performed on the day that the oocyte is retrieved. Microarray analysis will will be performed and compared with FISH and microarray analysis of day 3 or day 5 biopsy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of oocytes retrieved and embryos generated |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| live birth rate |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infertility, in vitro maturation (IVM), in vitro fertilization (IVF), natural cycle