NCT00561808

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

March 9, 2010

Status Verified

March 1, 2010

First QC Date

November 19, 2007

Last Update Submit

March 8, 2010

Conditions

Polycystic Ovarian Syndrome

Keywords

PCO/PCODIVMImmature Oocytes

Outcome Measures

Primary Outcomes (1)

  • Maturation rate of oocytes, their fertilization rate, cleavage rate and embryo quality.

    one year

Secondary Outcomes (1)

  • Implantation rate and successful delivery.

    one year

Study Arms (1)

Observational

EXPERIMENTAL
Other: In-vitro maturation oocytes

Interventions

In-vitro maturation oocytesOTHER

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.

Observational

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Every one else

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IVF Unit, Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

In Vitro Oocyte Maturation Techniques

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Reproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative Techniques

Study Officials

  • Adrian Ellenbogen, MD

    IVF Unit, Hillel Yaffe Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 19, 2007

First Posted

November 21, 2007

Study Start

January 1, 2008

Study Completion

January 1, 2009

Last Updated

March 9, 2010

Record last verified: 2010-03

Locations

IL(1)