Can Dormant Perimenopausal Ovarian Follicles Become FSH Responsive?
Can Dormant Ovarian Follicles From Perimenopausal Women Become Gonadotropin Responsive by Incubation With PTEN Inhibitor and PI3K Activating Peptide?
1 other identifier
interventional
10
1 country
1
Brief Summary
The purpose of this study to obtain ovarian cortical fragments from perimenopausal patients, who undergo pelvic organ surgery and test whether treatment with PTEN inhibitor and PI3K activating peptide would induce these fragments to produce FSH responsive follicles in the nude mouse model.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2010
1 active site
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
September 12, 2010
CompletedFirst Posted
Study publicly available on registry
September 14, 2010
CompletedStudy Start
First participant enrolled
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedSeptember 14, 2010
September 1, 2010
1 year
September 12, 2010
September 13, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ability of primordial follicles to respond to FSH after incubation
Human ovarian fragments will be incubated with PTEN inhibitor and PI3K activating peptide and will then be transplanted to nude mice. Subsequently mice will recieve FSH, and follicular response will be monitored.
Two weeks
Study Arms (1)
Patients
NO INTERVENTIONPerimenopausal women, who will undergo oelvic organ surgery, and will allow harvest of about half an oary for the study purpose
Interventions
Eligibility Criteria
You may qualify if:
- Women older than 45 years, undergoing pelvic organ surgery
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Obstetrics and Gynecology, Baruch Padeh Medical Center, Poria
Tiberias, 15208, Israel
Related Publications (3)
Hansen KR, Knowlton NS, Thyer AC, Charleston JS, Soules MR, Klein NA. A new model of reproductive aging: the decline in ovarian non-growing follicle number from birth to menopause. Hum Reprod. 2008 Mar;23(3):699-708. doi: 10.1093/humrep/dem408. Epub 2008 Jan 11.
PMID: 18192670RESULTLi J, Kawamura K, Cheng Y, Liu S, Klein C, Liu S, Duan EK, Hsueh AJ. Activation of dormant ovarian follicles to generate mature eggs. Proc Natl Acad Sci U S A. 2010 Jun 1;107(22):10280-4. doi: 10.1073/pnas.1001198107. Epub 2010 May 17.
PMID: 20479243RESULTYoon TK, Kim TJ, Park SE, Hong SW, Ko JJ, Chung HM, Cha KY. Live births after vitrification of oocytes in a stimulated in vitro fertilization-embryo transfer program. Fertil Steril. 2003 Jun;79(6):1323-6. doi: 10.1016/s0015-0282(03)00258-9.
PMID: 12798878RESULT
Study Officials
- STUDY CHAIR
Izhar Ben-Shlomo, MD
Dept. Ob/Gyn, Baruch Padeh Medical Center, Poria, Israel
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
September 12, 2010
First Posted
September 14, 2010
Study Start
November 1, 2010
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
September 14, 2010
Record last verified: 2010-09