In Vitro Maturation (IVM) of Human Oocytes

Infertility Clinical Trial

— IVM  

Official title:

In Vitro Maturation (IVM) of Human Oocytes

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01550861
• Other study ID #: 1201012117
• Status: Terminated
• Phase: N/A
• Start date: February 15, 2012
• Est. completion date: September 18, 2023

Study information

• Verified date: November 2023
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: September 18, 2023
• Est. primary completion date: October 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Procedure:
• in vitro maturation
Maturation of immature oocytes in the laboratory following oocyte retrieval
• 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.

Locations

Country	Name	City	State
United States	Center for Reproductive Medicine- Weill Cornell Medical College	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of oocytes retrieved and embryos generated		1 year
Secondary	live birth rate		1 year

External Links

•   Center for Reproductive Medicine- Weill Cornell Medical College