In Vitro Maturation (IVM) of Human Oocytes

Not Applicable

Terminated

• Conditions: Infertility
• Interventions: Procedure: in vitro maturation; Procedure: Polar Body Biopsy with preimplantation genetic screening

• Registration Number: NCT01550861
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

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

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-02-15
• Study First Submitted: 2012-02-16
• Study First Submitted QC: 2012-03-07
• Study First Posted: 2012-03-12
• Primary Completion: 2022-10-15
• Study Completion: 2023-09-18
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 2

Inclusion Criteria

1. Each subject must be female.
2. Each subject must have an indication for COH and IVF with or without ICSI.
3. Each subject must be willing and able to provide written informed consent for the trial
4. Each subject must be 25 to ≤42 years of age at the time of signing informed consent.
5. 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

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Exclusion Criteria

1. Subject with premature ovarian failure
2. Subject with endocrine abnormalities such as hyperprolactinaemia or thyroid dysfunction
3. Subject with malformation or absence of uterus
4. 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).
5. Subject with contraindication or allergy/hypersensitivity to hCG, estrogen and progesterone

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
In vitro Maturation	Polar Body Biopsy with preimplantation genetic screening	in vitro maturation of immature oocytes
In vitro Maturation	in vitro maturation	in vitro maturation of immature oocytes

Primary Outcome Measures

Name	Time	Method
number of oocytes retrieved and embryos generated	1 year

Secondary Outcome Measures

Name	Time	Method
live birth rate	1 year

Trial Locations

Locations (1)

Center for Reproductive Medicine- Weill Cornell Medical College; 🇺🇸 New York, New York, United States