In Vitro Maturation (IVM) of Human Oocytes

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01550861
First received: February 16, 2012
Last updated: November 20, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention
Infertility
Procedure: in vitro maturation
Procedure: Polar Body Biopsy with preimplantation genetic screening

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: IN VITRO MATURATION (IVM) OF HUMAN OOCYTES

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • number of oocytes retrieved and embryos generated [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • live birth rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: February 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   25 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01550861

Locations
United States, New York
Center for Reproductive Medicine- Weill Cornell Medical College
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Zev Rosenwaks, MD Weill Cornell
  More Information

Additional Information:
No publications provided

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01550861     History of Changes
Other Study ID Numbers: 1201012117
Study First Received: February 16, 2012
Last Updated: November 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
infertility
in vitro maturation (IVM)
in vitro fertilization (IVF)
natural cycle

Additional relevant MeSH terms:
Infertility
Genital Diseases, Female
Genital Diseases, Male

ClinicalTrials.gov processed this record on October 23, 2014