Infertility
Conditions
Keywords
infertility, in vitro maturation (IVM), in vitro fertilization (IVF), natural cycle
Brief summary
The objectives of this study are to evaluate the clinical efficacy of Natural in vitro Fertilization and in vitro maturation.
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.
Interventions
PROCEDUREin vitro maturation
Maturation of immature oocytes in the laboratory following oocyte retrieval
PROCEDUREPolar 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.
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 42 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of oocytes retrieved and embryos generated | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| live birth rate | 1 year |
Countries
United States
Outcome results
None listed