This trial is active, not recruiting.

Condition infertility
Treatments in vitro maturation, polar body biopsy with preimplantation genetic screening
Sponsor Weill Medical College of Cornell University
Start date February 2012
End date December 2016
Trial size 40 participants
Trial identifier NCT01550861, 1201012117


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
in vitro maturation of immature oocytes
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.

Primary Outcomes

number of oocytes retrieved and embryos generated
time frame: 1 year

Secondary Outcomes

live birth rate
time frame: 1 year

Eligibility Criteria

Female participants from 25 years up to 42 years old.

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

Additional Information

Principal investigator Zev Rosenwaks, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Weill Medical College of Cornell University.