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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014