In-Vitro Maturation of Oocytes From Polycystic Ovarian Patients Undergoing IVF (IVM)

This study has been completed.
Sponsor:
Information provided by:
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT00561808
First received: November 19, 2007
Last updated: March 8, 2010
Last verified: March 2010
  Purpose

Retrieval of immature oocytes from women with polycystic ovaries, their in-vitro maturation, fertilization and embryo transfer can prevent hormonal treatment that can lead to ovarian hyperstimulation. In addition, it can decrease discomfort and side-effects of routine daily administration of hormones and it can be cost-effective. Thirty healthy women with Polycystic Ovarian Syndrome aged 20-35, with BMI 18-30 kg/msq will be included in the study. Their immature oocytes will be retrieved from small follicles without any hormonal treatment. The oocytes will be fertilized post in-vitro maturation. The developed embryros will be transferred to the patients as in a routine IVF cycle.


Condition Intervention
Polycystic Ovarian Syndrome
Other: In-vitro maturation oocytes

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: In-Vitro Maturation of Oocytes From Polycystic Ovarian Patients Undergoing IVF

Resource links provided by NLM:


Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • Maturation rate of oocytes, their fertilization rate, cleavage rate and embryo quality. [ Time Frame: one year ]

Secondary Outcome Measures:
  • Implantation rate and successful delivery. [ Time Frame: one year ]

Enrollment: 30
Study Start Date: January 2008
Study Completion Date: January 2009
Arms Assigned Interventions
Experimental: Observational Other: In-vitro maturation oocytes
Immature oocytes (development stage GV or M1) will be matured in-vitro in IVM culture medium for approximately 28-32 hours. The oocytes will be routinely observed and when they reach maturation (M2) they will be fertilized. The developed embryo will be transferred to the patient 24 hours post-fertilization.

  Eligibility

Ages Eligible for Study:   20 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy women diagnosed with Polycystic Ovarian Syndrome with BMI 18-30 kg/sqm, aged 20-35

Exclusion Criteria:

  • Every one else
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00561808

Locations
Israel
IVF Unit, Hillel Yaffe Medical Center
Hadera, Israel, 38100
Sponsors and Collaborators
Hillel Yaffe Medical Center
Investigators
Study Director: Adrian Ellenbogen, MD IVF Unit, Hillel Yaffe Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00561808     History of Changes
Other Study ID Numbers: 30/2007
Study First Received: November 19, 2007
Last Updated: March 8, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hillel Yaffe Medical Center:
PCO/PCOD
IVM
Immature Oocytes

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014