Mechanical Stimulation of the Ovary for Infertility Treatment in Patients With Very Low Ovarian Reserve
Primary Purpose
Ovarian Stimulation
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Resection of ovarian tissue and mechanical stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Stimulation focused on measuring Mechanical Laboratory Ovarian Stimulation Poor responders
Eligibility Criteria
Inclusion Criteria:
- Healthy women, aged 21-40. with premature ovarian failure.
- Healthy women, with poor ovarian reserve, aged 38-45, undergoing IVF Low ovarian response: recruitment of up to three eggs in previous treatments.
- After the failure of at least 4 cycles.
- Two functioning ovaries, follicular and hormonal response of both ovaries in prior therapies.
- Women candidates for egg donation, and seeking further treatment before switching to egg donation.
Exclusion Criteria:
- Women with kidney disease.
- Women with infertility factors other than ovarian failure, such as endometriosis, PCOS, male factor.
- Women with one non-functioning ovary, or that was removed.
- Women with an intrauterine or pelvic pathology.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mechanical stimulation
Arm Description
Mechanical stimulation of ovarian tissue
Outcomes
Primary Outcome Measures
Menstrual cycle surveillance
Duration of the menstrual period (days)
AMH
Ovarian reserve measurements. AMH levels ng/ml
Estradiol
Estradiol levels at day of HCG in Pmol/L
Antral follicular count
measurement of. any antral follicles at day 3-5 with ultrasound
IVF outcomes
Number of oocytes at OPU
FSH levels
FSH levels at. day 2-3 of menstruation IU/L
IVF outcomes fertilization rates
fertilization rate. - number of fertilized oocytes relatively to total number of oocytes
IVF outcomes
pregnancy rates
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03298750
Brief Title
Mechanical Stimulation of the Ovary for Infertility Treatment in Patients With Very Low Ovarian Reserve
Official Title
Mechanical Stimulation of the Ovary for Infertility Treatment in Patients With Very Low Ovarian Reserve
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 20, 2017 (Anticipated)
Primary Completion Date
September 1, 2019 (Anticipated)
Study Completion Date
September 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheba Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Examine the possibility that mechanical stimulation and ovarian fragmentation in women with premature ovarian failure or low ovarian reserve intended for egg donation may cause early follicular recruitment and increase chances of achieving pregnancy through IVF.
Detailed Description
The women will undergo a surgical laparoscopy during which one of the two technique will ensue.
One of the ovaries will be scratched ( 2 mm depth) with a knife. Simultaneously, a piece of the ovary will be preserved for further histologic analysis and research in the laboratory.
A piece of one ovary will be resected (up to one third of the ovary's volume, without harming the other ovary.
The resected ovarian tissue will be transferred immediately to the laboratory where the cortex will be divided from the medulla and sliced to small pieces of 1-2 square millimeters.
These pieces will be transferred back to the operation room in order for them to be transplanted under the serosa layer of the remaining ovary.
Any bleeding would be stopped using a stiches or hemostatic mesh (diathermy will not be used).
Simultaneously, a piece of the ovary will be preserved for further histologic analysis and research in the laboratory.
Post operational follow up ( up to two years) including: menstrual cycle surveillance, hormonal profile, AMH level, US of the pelvis and Antral Follicles Count (AFC).
A month after the surgery, an ovarian stimulation will commence following IVF while close monitoring the ovarian response and comparing the pre and post operation response.
Moreover, the treated ovary will be compared to the untreated one: using the US the ovarian volume and antral follicles size and count will be evaluated.
The preserved pieces of ovary will be histologically evaluated for ovarian reserve analysis.
Additionally, these pieces will be used for experiments for the evaluation of various methods for primordial follicles stimulation including mechanical stimulation like the laser or using substances like Akt Stimulators.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Stimulation
Keywords
Mechanical Laboratory Ovarian Stimulation Poor responders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mechanical stimulation
Arm Type
Experimental
Arm Description
Mechanical stimulation of ovarian tissue
Intervention Type
Procedure
Intervention Name(s)
Resection of ovarian tissue and mechanical stimulation
Intervention Description
he women will undergo a surgical laparoscopy during which one of the two technique will ensue.
One of the ovaries will be scratched ( 2 mm depth) with a knife. Simultaneously, a piece of the ovary will be preserved for further histologic analysis and research in the laboratory.
A piece of one ovary will be resected (up to one third of the ovary's volume, without harming the other ovary.
The resected ovarian tissue will be transferred immediately to the laboratory where the cortex will be divided from the medulla and sliced to small pieces of 1-2 square millimeters.
These pieces will be transferred back to the operation room in order for them to be transplanted under the serosa layer of the remaining ovary.
Any bleeding would be stopped using a stiches or hemostatic mesh (diathermy will not be used).
Simultaneously, a piece of the ovary will be preserved for further histologic analysis and research in the laboratory.
Primary Outcome Measure Information:
Title
Menstrual cycle surveillance
Description
Duration of the menstrual period (days)
Time Frame
2 years
Title
AMH
Description
Ovarian reserve measurements. AMH levels ng/ml
Time Frame
2 years
Title
Estradiol
Description
Estradiol levels at day of HCG in Pmol/L
Time Frame
2 years
Title
Antral follicular count
Description
measurement of. any antral follicles at day 3-5 with ultrasound
Time Frame
2 years
Title
IVF outcomes
Description
Number of oocytes at OPU
Time Frame
2 years
Title
FSH levels
Description
FSH levels at. day 2-3 of menstruation IU/L
Time Frame
2 years
Title
IVF outcomes fertilization rates
Description
fertilization rate. - number of fertilized oocytes relatively to total number of oocytes
Time Frame
2 years
Title
IVF outcomes
Description
pregnancy rates
Time Frame
2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy women, aged 21-40. with premature ovarian failure.
Healthy women, with poor ovarian reserve, aged 38-45, undergoing IVF Low ovarian response: recruitment of up to three eggs in previous treatments.
After the failure of at least 4 cycles.
Two functioning ovaries, follicular and hormonal response of both ovaries in prior therapies.
Women candidates for egg donation, and seeking further treatment before switching to egg donation.
Exclusion Criteria:
Women with kidney disease.
Women with infertility factors other than ovarian failure, such as endometriosis, PCOS, male factor.
Women with one non-functioning ovary, or that was removed.
Women with an intrauterine or pelvic pathology.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alon Kedem, MD
Phone
972543456953
Email
kedem2001@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Noam Domniz, MD
Phone
972528899242
Email
domniz@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alon Kedem, MD
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Mechanical Stimulation of the Ovary for Infertility Treatment in Patients With Very Low Ovarian Reserve
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