WithdrawnNot Applicable

In Vitro Maturation (IVM) of Human Oocytes

Stopped: Institutional approval of study has expired.

United States0Started 2015-01

Plain-language 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 infertility patients who cannot tolerate exogenous gonadotropins or are at risk of ovarian hyperstimulation syndrome.

Who can participate

Age range25 Years – 42 Years

SexFEMALE

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Pregnancy

Timeframe: 1 month

Implantation

Timeframe: 1 month

live birth rates

Timeframe: 9 months

Trial details

NCT IDNCT01843569

SponsorNorthwell Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12

View on ClinicalTrials.gov More Polycystic Ovarian Syndrome (PCOS) trials