Ovarian StimulationNCT03298750
Mechanical Stimulation of the Ovary for Infertility Treatment in Patients With Very Low Ovarian Reserve
A study testing Resection of ovarian tissue and mechanical stimulation in people with Ovarian Stimulation, run by Sheba Medical Center.
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. Read more about this study
- Who is it for?
- Ages 21 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Stimulation
- What is being tested?
- Resection of ovarian tissue and mechanical stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2017to 1 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the detailed description
The 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.
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
- Being tested
- Resection of ovarian tissue and mechanical stimulation
- Keywords
- Mechanical Laboratory Ovarian Stimulation Poor responders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resection of ovarian tissue and mechanical stimulationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Mechanical stimulation | Experimental | Mechanical stimulation of ovarian tissue Receives: Procedure: Resection of ovarian tissue and mechanical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menstrual cycle surveillance
Duration of the menstrual period (days)
Measured: 2 years
AMH
Ovarian reserve measurements. AMH levels ng/ml
Measured: 2 years
Estradiol
Estradiol levels at day of HCG in Pmol/L
Measured: 2 years
Antral follicular count
measurement of. any antral follicles at day 3-5 with ultrasound
Measured: 2 years
IVF outcomes
Number of oocytes at OPU
Measured: 2 years
FSH levels
FSH levels at. day 2-3 of menstruation IU/L
Measured: 2 years
IVF outcomes fertilization rates
fertilization rate. - number of fertilized oocytes relatively to total number of oocytes
Measured: 2 years
IVF outcomes
pregnancy rates
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2017
- Study start20 Oct 2017 (estimated)
- Primary completion1 Sep 2019 (estimated)
- Study completion1 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian StimulationStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Alon Kedem, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03298750
- Sponsor's protocol ID
- SHEBA-15-2289-AK-CTIL
- Status last verified
- Oct 2017
- First submitted
- 26 Jun 2016
- Last updated
- 10 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Stimulation of the Ovary for Infertility Treatment in Patients With Very Low Ovarian Reserve
- ClinicalTrials.gov ID
- NCT03298750
- Acronym / sponsor ID
- SHEBA-15-2289-AK-CTIL
- Conditions
- Ovarian Stimulation
- Keywords
- Mechanical Laboratory Ovarian Stimulation Poor responders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 20 Oct 2017 (estimated)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 2 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mechanical stimulation | Experimental | Procedure: Resection of ovarian tissue and mechanical stimulationMechanical stimulation of ovarian tissue |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resection of ovarian tissue and mechanical stimulationhe 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. | Procedure or surgery | Mechanical stimulation |
Primary outcome
Menstrual cycle surveillance
Time frame: 2 years
Duration of the menstrual period (days)
AMH
Time frame: 2 years
Ovarian reserve measurements. AMH levels ng/ml
Estradiol
Time frame: 2 years
Estradiol levels at day of HCG in Pmol/L
Antral follicular count
Time frame: 2 years
measurement of. any antral follicles at day 3-5 with ultrasound
IVF outcomes
Time frame: 2 years
Number of oocytes at OPU
FSH levels
Time frame: 2 years
FSH levels at. day 2-3 of menstruation IU/L
IVF outcomes fertilization rates
Time frame: 2 years
fertilization rate. - number of fertilized oocytes relatively to total number of oocytes
IVF outcomes
Time frame: 2 years
pregnancy rates
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alon Kedem, MD principal investigator
Sheba Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Resection of ovarian tissue and mechanical stimulation in people with Ovarian Stimulation, run by Sheba Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alon Kedem, MD (972543456953, kedem2001@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menstrual cycle surveillance (time frame: 2 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2017.