In Vitro Maturation (IVM) of Human Oocytes

NCT ID: NCT01550861

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-15

Study Completion Date

2023-09-18

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.

Conditions

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Infertility

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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In vitro Maturation

in vitro maturation of immature oocytes

Group Type EXPERIMENTAL

in vitro maturation

Intervention Type PROCEDURE

Maturation of immature oocytes in the laboratory following oocyte retrieval

Polar Body Biopsy with preimplantation genetic screening

Intervention Type PROCEDURE

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.

Interventions

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in vitro maturation

Maturation of immature oocytes in the laboratory following oocyte retrieval

Intervention Type PROCEDURE

Polar Body Biopsy with preimplantation genetic screening

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

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
Minimum Eligible Age

25 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zev Rosenwaks, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Cornell

Locations

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Center for Reproductive Medicine- Weill Cornell Medical College

New York, New York, United States

Site Status

Countries

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United States

Related Links

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http://ivf.org

Center for Reproductive Medicine- Weill Cornell Medical College

Other Identifiers

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1201012117

Identifier Type: -

Identifier Source: org_study_id

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