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WITHDRAWN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