NCT03298750

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Sheba Medical Center · Other Government
• Sex: Female
• Age: 21 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Ovarian Stimulation

Interventions

Type	Name	Description
PROCEDURE	Resection of ovarian tissue and mechanical stimulation	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.

Timeline

• Start date: 2017-10-20
• Primary completion: 2019-09-01
• Completion: 2019-09-01
• First posted: 2017-10-02
• Last updated: 2017-10-10