In Vitro Maturation (IVM) of Human Oocytes

NCT01550861 | Terminated

• 1 other identifier: 1201012117
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Infertility

Keywords

infertility; in vitro maturation (IVM); in vitro fertilization (IVF); natural cycle

Outcome Measures

Primary Outcomes (1)

• number of oocytes retrieved and embryos generated

  1 year

Secondary Outcomes (1)

• live birth rate

  1 year

Study Arms (1)

In vitro Maturation

EXPERIMENTAL

in vitro maturation of immature oocytes

Procedure: in vitro maturation; Procedure: Polar Body Biopsy with preimplantation genetic screening

Interventions

in vitro maturation PROCEDURE

Maturation of immature oocytes in the laboratory following oocyte retrieval

In vitro Maturation

Polar Body Biopsy with preimplantation genetic screening 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.

In vitro Maturation

Eligibility Criteria

• Age: 25 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Center for Reproductive Medicine- Weill Cornell Medical College

New York, New York, 10021, United States

Location

Related Links

• Center for Reproductive Medicine- Weill Cornell Medical College

MeSH Terms

Conditions

Infertility

Interventions

In Vitro Oocyte Maturation Techniques

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques

Study Officials

• Zev Rosenwaks, MD

  Weill Cornell

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2012
• First Posted: March 12, 2012
• Study Start: February 15, 2012
• Primary Completion: October 15, 2022
• Study Completion: September 18, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

US (1)