In Vitro Maturation (IVM) of Human Oocytes
This trial is active, not recruiting.
|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.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
number of oocytes retrieved and embryos generated
time frame: 1 year
live birth rate
time frame: 1 year
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
|Official title||IN VITRO MATURATION (IVM) OF HUMAN OOCYTES|
|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.|
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