In Vitro Maturation (IVM) of Human Oocytes

Sponsor

Weill Medical College of Cornell University (Other)

Overall Status

Recruiting

CT.gov ID

NCT01550861

Collaborator

(none)

Enrollment

Location

Arm

153.5

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Infertility	Procedure: in vitro maturation Procedure: Polar Body Biopsy with preimplantation genetic screening	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

In Vitro Maturation (IVM) of Human Oocytes

Actual Study Start Date :

Feb 15, 2012

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

number of oocytes retrieved and embryos generated [1 year]

Secondary Outcome Measures

live birth rate [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 42 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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