In-Vitro Maturation of Oocytes From Polycystic Ovarian Patients Undergoing IVF (IVM)
This study has been completed.
Sponsor:
Hillel Yaffe Medical Center
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
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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 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 May 22, 2013