Back to resultsIn-Vitro Maturation of Oocytes From Polycystic Ovarian Patients Undergoing IVF (IVM)
Primary Purpose
Polycystic Ovarian Syndrome
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
In-vitro maturation oocytes
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovarian Syndrome focused on measuring PCO/PCOD, IVM, Immature Oocytes
Eligibility Criteria
Inclusion Criteria:
- Healthy women diagnosed with Polycystic Ovarian Syndrome with BMI 18-30 kg/sqm, aged 20-35
Exclusion Criteria:
- Every one else
Sites / Locations
- IVF Unit, Hillel Yaffe Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Observational
Arm Description
Outcomes
Primary Outcome Measures
Maturation rate of oocytes, their fertilization rate, cleavage rate and embryo quality.
Secondary Outcome Measures
Implantation rate and successful delivery.
Full Information
NCT ID
NCT00561808
First Posted
November 19, 2007
Last Updated
March 8, 2010
Sponsor
Hillel Yaffe Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00561808
Brief Title
In-Vitro Maturation of Oocytes From Polycystic Ovarian Patients Undergoing IVF
Acronym
IVM
Official Title
In-Vitro Maturation of Oocytes From Polycystic Ovarian Patients Undergoing IVF
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hillel Yaffe Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovarian Syndrome
Keywords
PCO/PCOD, IVM, Immature Oocytes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Observational
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
In-vitro maturation oocytes
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maturation rate of oocytes, their fertilization rate, cleavage rate and embryo quality.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Implantation rate and successful delivery.
Time Frame
one year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy women diagnosed with Polycystic Ovarian Syndrome with BMI 18-30 kg/sqm, aged 20-35
Exclusion Criteria:
Every one else
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian Ellenbogen, MD
Organizational Affiliation
IVF Unit, Hillel Yaffe Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
IVF Unit, Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
In-Vitro Maturation of Oocytes From Polycystic Ovarian Patients Undergoing IVF
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