In Vitro Maturation (IVM) of Human Oocytes (IVM)

November 15, 2023 updated by: Weill Medical College of Cornell University
The objectives of this study are to evaluate the clinical efficacy of Natural in vitro Fertilization and in vitro maturation.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mitasha Joseph, RN, MPA
  • Phone Number: 646-962-3382

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Center for Reproductive Medicine- Weill Cornell Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 42 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: In vitro Maturation
in vitro maturation of immature oocytes
Procedure: in vitro maturation
Maturation of immature oocytes in the laboratory following oocyte retrieval
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of oocytes retrieved and embryos generated
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
live birth rate
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Investigators

  • Principal Investigator: Zev Rosenwaks, MD, Weill Cornell

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2012

Primary Completion (Actual)

October 15, 2022

Study Completion (Actual)

September 18, 2023

Study Registration Dates

First Submitted

February 16, 2012

First Submitted That Met QC Criteria

March 7, 2012

First Posted (Estimated)

March 12, 2012

Study Record Updates

Last Update Posted (Estimated)

November 17, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1201012117

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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