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

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ClinicalTrials.gov Identifier: NCT00561808
Recruitment Status : Completed
First Posted : November 21, 2007
Last Update Posted : March 9, 2010
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Polycystic Ovarian Syndrome Other: In-vitro maturation oocytes

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: In-Vitro Maturation of Oocytes From Polycystic Ovarian Patients Undergoing IVF
Study Start Date : January 2008
Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.

Outcome Measures

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

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

Eligibility Criteria

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00561808

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

ClinicalTrials.gov Identifier: NCT00561808     History of Changes
Other Study ID Numbers: 30/2007
First Posted: November 21, 2007    Key Record Dates
Last Update Posted: March 9, 2010
Last Verified: March 2010

Keywords provided by Hillel Yaffe Medical Center:
Immature Oocytes

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