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NCT00561808 Clinical Trial

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

Polycystic Ovarian Syndrome Clinical Trial

— IVM  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00561808
Other study ID # 30/2007
Secondary ID
Status Completed
Phase N/A
First received November 19, 2007
Last updated March 8, 2010
Start date January 2008
Est. completion date January 2009

Study information
Verified date March 2010
Source Hillel Yaffe Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date January 2009
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 35 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Every one else

Study Design

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

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Israel IVF Unit, Hillel Yaffe Medical Center Hadera

Sponsors (1)
Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Maturation rate of oocytes, their fertilization rate, cleavage rate and embryo quality. one year
Secondary Implantation rate and successful delivery. one year
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