NCT03298750

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Status
unknown

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

June 26, 2016

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

October 2, 2017

Completed
18 days until next milestone

Study Start

First participant enrolled

October 20, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

October 10, 2017

Status Verified

October 1, 2017

Enrollment Period

1.9 years

First QC Date

June 26, 2016

Last Update Submit

October 9, 2017

Conditions

Ovarian Stimulation

Keywords

Mechanical Laboratory Ovarian Stimulation Poor responders

Outcome Measures

Primary Outcomes (8)

  • Menstrual cycle surveillance

    Duration of the menstrual period (days)

    2 years

  • AMH

    Ovarian reserve measurements. AMH levels ng/ml

    2 years

  • Estradiol

    Estradiol levels at day of HCG in Pmol/L

    2 years

  • Antral follicular count

    measurement of. any antral follicles at day 3-5 with ultrasound

    2 years

  • IVF outcomes

    Number of oocytes at OPU

    2 years

  • FSH levels

    FSH levels at. day 2-3 of menstruation IU/L

    2 years

  • IVF outcomes fertilization rates

    fertilization rate. - number of fertilized oocytes relatively to total number of oocytes

    2 years

  • IVF outcomes

    pregnancy rates

    2 years

Study Arms (1)

Mechanical stimulation

EXPERIMENTAL

Mechanical stimulation of ovarian tissue

Procedure: Resection of ovarian tissue and mechanical stimulation

Interventions

Resection of ovarian tissue and mechanical stimulationPROCEDURE

he women will undergo a surgical laparoscopy during which one of the two technique will ensue. 1. 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. 2. 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.

Mechanical stimulation

Eligibility Criteria

Age21 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Alon Kedem, MD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alon Kedem, MD

CONTACT

972543456953kedem2001@gmail.com

Noam Domniz, MD

CONTACT

972528899242domniz@gmail.com

Study Design

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

Study Record Dates

First Submitted

June 26, 2016

First Posted

October 2, 2017

Study Start

October 20, 2017

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

October 10, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share