Status:
WITHDRAWN
In Vitro Maturation (IVM) of Human Oocytes
Lead Sponsor:
Northwell Health
Conditions:
Polycystic Ovarian Syndrome (PCOS)
Patients Sensitive to Exogenous Gonadotropins
Eligibility:
FEMALE
25-42 years
Phase:
NA
Brief Summary
We hypothesize that the combination of natural cycle IVF or low dose gonadotropin injection combined with In Vitro Maturation (IVM) (Natural IVF/IVM) is a viable option for a selected population of in...
Detailed Description
Natural IVF/IVM may be an attractive treatment alternative to conventional controlled ovarian hyperstimulation (COH)/IVF treatment for infertile women in particular for a select group. Natural IVF/IV...
Eligibility Criteria
Inclusion
- Each subject must be female.
- Each subject must have an indication for COH and IVF or ICSI.
- Each subject must be willing and able to provide written informed consent for the trial.
- Each subject must be ≤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
- Subject with premature ovarian failure.
- Subject with endocrine abnormalities such as hyperprolactinaemia or thyroid dysfunction.
- Subject with malformation or absence of uterus.
- Subject 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.
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01843569
Start Date
January 1 2015
End Date
December 1 2020
Last Update
November 16 2020
Active Locations (1)
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1
The Center for Human Reproduction
Manhasset, New York, United States, 11030