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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.
The women will undergo a surgical laparoscopy during which one of the two technique will ensue.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mechanical stimulation | Experimental | Mechanical stimulation of ovarian tissue |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resection of ovarian tissue and mechanical stimulation | Procedure | he women will undergo a surgical laparoscopy during which one of the two technique will ensue.
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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alon Kedem, MD | Contact | 972543456953 | kedem2001@gmail.com | |
| Noam Domniz, MD | Contact | 972528899242 | domniz@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Alon Kedem, MD | Sheba Medical Center | Principal Investigator |
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