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

Ovarian Stimulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03298750
• Other study ID #: SHEBA-15-2289-AK-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: June 26, 2016
• Last updated: October 9, 2017
• Start date: October 20, 2017
• Est. completion date: September 1, 2019

Study information

• Verified date: October 2017
• Source: Sheba Medical Center
• Contact: Alon Kedem, MD
• Phone: 972543456953
• Email: kedem2001[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Ovarian Stimulation

Intervention

Procedure:
• Resection of ovarian tissue and mechanical stimulation
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Menstrual cycle surveillance	Duration of the menstrual period (days)	2 years
Primary	AMH	Ovarian reserve measurements. AMH levels ng/ml	2 years
Primary	Estradiol	Estradiol levels at day of HCG in Pmol/L	2 years
Primary	Antral follicular count	measurement of. any antral follicles at day 3-5 with ultrasound	2 years
Primary	IVF outcomes	Number of oocytes at OPU	2 years
Primary	FSH levels	FSH levels at. day 2-3 of menstruation IU/L	2 years
Primary	IVF outcomes fertilization rates	fertilization rate. - number of fertilized oocytes relatively to total number of oocytes	2 years
Primary	IVF outcomes	pregnancy rates	2 years