Mechanical Stimulation of the Ovary for Infertility Treatment in Patients

Status Not yet recruiting

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03298750
Study type	Interventional
Source	Sheba Medical Center
Contact	Alon Kedem, MD
Phone	972543456953
Email	kedem2001@gmail.com
Status	Not yet recruiting
Phase	N/A
Start date	October 20, 2017
Completion date	September 1, 2019

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See also
Status	Clinical Trial	Phase
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Not yet recruiting	`NCT04539067` - Effect of Controlled Ovarian Stimulation in Quality of Oocyte and Embryo	Phase 2
Recruiting	`NCT02715336` - Efficacy and Safety of Medication Used to Stimulate Ovulation	Phase 4
Completed	`NCT03939403` - Conventional Ovarian Stimulation vs. Single Injection Stimulation of Corifollitropin Alfa in Oocyte Donor	Phase 4
Recruiting	`NCT06142708` - The Effect of Dual Trigger (GnRH Agonist + hCG) for Final Maturation in Oocyte Donors With History of a Previous Cycle With Suboptimal Response to GnRH Agonist Only Trigger	N/A
Recruiting	`NCT05166668` - Letrozole /GnRH Antagonist Protocol in Women Over 40 Years Undergoing ICSI Cycle	N/A
Completed	`NCT04549649` - The Effect of Dual Trigger for Final Oocyte Maturation on IVF/ICSI Outcomes in Patients With Suboptimal Ovarian Response	N/A
Terminated	`NCT01816789` - Age Versus Ovarian Reserve Markers Based Therapy in IVF (IVF)/Intracytoplasmic Sperm Injection (ICSI) Cycles	Phase 4
Completed	`NCT00823004` - Antagonist/Letrozole in Poor Responders	Phase 1/Phase 2
Not yet recruiting	`NCT06175832` - PPOS (Progestin Primed Ovarian Stimulation) and Corifollitropin Alfa (CFA) Cross-over Study	Phase 4
Completed	`NCT00830492` - Clomiphene Citrate (CC)/Gonadotropin/Gonadotropin Releasing Hormone (GnRH) Antagonist Versus Gonadotropin/GnRH Agonist	Phase 4
Completed	`NCT01145144` - Dehydroepiandrosterone Supplementation for Poor Responder Patients During in Vitro Fertilization Treatment	N/A
Completed	`NCT00829075` - Impact of Three Different Gonadotrophin Regimes on Egg Donation Program	Phase 4
Completed	`NCT01037699` - Luteinizing Hormone (LH) Supplementation in Gonadotropin-releasing Hormone (GnRH) Antagonist Cycles	Phase 3
Completed	`NCT01112358` - Lutropin Alfa in Women at Risk of Poor Response	Phase 2
Recruiting	`NCT03400722` - Double Ovarian Stimulation as Accumulation Strategy for Older Infertile Patients With Suboptimal Ovarian Response	Phase 4
Completed	`NCT00669786` - Human Menopausal Gonadotropin (HMG) vs Recombinant Follicle Stimulating Hormone (rFSH) in Gonadotropin Releasing Hormone (GnRH) Antagonist Cycles	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms