Clinical trial NCT03298750: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Ovarian Stimulation
Keywords: Mechanical Laboratory Ovarian Stimulation Poor responders
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2017-10-02
Enrollment: 10
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

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.

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.

Primary outcomes:
measure: Menstrual cycle surveillance
timeFrame: 2 years
measure: AMH
timeFrame: 2 years
measure: Estradiol
timeFrame: 2 years
measure: Antral follicular count
timeFrame: 2 years
measure: IVF outcomes
timeFrame: 2 years
measure: FSH levels
timeFrame: 2 years
measure: IVF outcomes fertilization rates
timeFrame: 2 years
measure: IVF outcomes
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sheba Medical Center
name: Alon Kedem, MD
role: PRINCIPAL_INVESTIGATOR
References: