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

History of Changes

Tracking Information

First Received Date ^ICMJE

November 19, 2007

Last Updated Date

March 8, 2010

Start Date ^ICMJE

January 2008

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00561808 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Implantation rate and successful delivery. [ Time Frame: one year ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Polycystic Ovarian Syndrome

Intervention ^ICMJE

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.

Study Arm (s)

Experimental: Observational

Intervention: Other: In-vitro maturation oocytes

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2009

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

Every one else

Gender

Female

Ages

20 Years to 35 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Israel

Administrative Information

NCT Number ^ICMJE

NCT00561808

Other Study ID Numbers ^ICMJE

30/2007

Has Data Monitoring Committee

Yes

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Hillel Yaffe Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Adrian Ellenbogen, MD

IVF Unit, Hillel Yaffe Medical Center

Information Provided By

Hillel Yaffe Medical Center

Verification Date

March 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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