search
Back to results

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
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Stimulation focused on measuring Mechanical Laboratory Ovarian Stimulation Poor responders

Eligibility Criteria

21 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

    First Posted
    June 26, 2016
    Last Updated
    October 9, 2017
    Sponsor
    Sheba Medical Center
    search

    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

    Learn more about this trial

    Mechanical Stimulation of the Ovary for Infertility Treatment in Patients With Very Low Ovarian Reserve

    We'll reach out to this number within 24 hrs