Poor Ovarian ResponseNCT04024722
Improving in Vitro Fertilization in Women With Poor Ovarian Response
A study testing In Vitro Fertilization in people with Poor Ovarian Response and Ovarian Insufficiency, run by Barzilai Medical Center at 1 site in Israel.
Trial summary
Improving the results of in vitro fertilization in women with poor ovarian response and early ovarian insufficiency Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Poor Ovarian Response, Ovarian Insufficiency
- What is being tested?
- In Vitro Fertilization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- 14 Jan 2020to 31 Jul 2022
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteers with poor ovarian response to standard fertility treatments according to the criteria of the European Fertility Association (ESHRE).
- Diagnosis of early ovarian insufficiency or symptoms that predict early ovarian insufficiency (imminent) seeking to become pregnant.
Who cannot join
- Volunteers with
- Severe endometriosis diagnosed with laparoscopy.
- Previous major surgery involving ovaries.
- Ovarian cancer.
- Female reproductive malformations.
- Contraindications for laparoscopic surgery.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Barzilay University Medical Center
Ashkelon
Shevach Friedler, Proffesor, 972 8 6748882, shevachf@bmc.gov.il
Yaniv Ovadia, Doctor, 972 8 6745220, yanivo@bmc.gov.il
About this study
Official title: Improving the Results of in Vitro Fertilization in Women With Poor Ovarian Response and Early Ovarian Insufficiency
Improving the results of in vitro fertilization in women with poor ovarian response and early ovarian insufficiency
Read the detailed description
BACKGROUND: Mechanical disruption of the Hippo signaling pathway in the ovaries can increase the likelihood of pregnancy and childbirth in women with early ovarian insufficiency. The method may also "work" in women with poor ovarian reserve and poor response to routine fertility treatments.
OBJECTIVE: To examine whether mechanical stimulation of ovaries by cutting the ovarian cortex treatment can increase eggs number aspirated during In Vitro Fertilization (IVF).
METHODS: Patients eligible for the study with poor ovarian response will receive treatment including laparoscopic surgery, resection, and transplantation of ovarian tissue in the same operation to improve the chances of IVF success and pregnancy. Participants will be assessed for surgical incisions and fertility assessment up to two weeks after treatment, including general physical examination, US pelvic examination, and blood tests for a hormonal profile to determine the initiation of ovarian stimulation and IVF. Patients will be monitored from 2 weeks to 1 year after treatment (once a week in the first two months and one month for one year after surgery), which will include a general physical examination, a pelvic ultrasound (US) and blood tests for the hormonal profile at the IVF clinic.
- Conditions
- Poor Ovarian Response, Ovarian Insufficiency
- Being tested
- In Vitro Fertilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In Vitro FertilizationProcedure or surgery
Patients suitable for research with poor ovarian response will receive treatment including laparoscopic surgery, resection, and transplantation of ovarian tissue in the same operation to improve the chances of success of in vitro fertilization and pregnancy. Participants will be assessed for surgical incisions and fertility assessment up to two weeks after treatment, including general physical examination, US pelvic examination, and blood tests for a hormonal profile to determine the initiation of ovarian stimulation and IVF. Patients will be monitored from 2 weeks to 1 year after treatment (once a week in the first two months and one month for one year after surgery), which will include a general physical examination, a US test, and blood tests for the hormonal profile at the IVF clinic.
| Study group | Role | What they receive |
|---|---|---|
| Single ovary treatment | Experimental | Not described Receives: Procedure: In Vitro Fertilization |
| Dual ovary treatment | Experimental | Not described Receives: Procedure: In Vitro Fertilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of oocytes
Number of oocytes
Measured: up to 1 year
Fertilization rate
Fertilization rate
Measured: up to 1 year
Embryos number
Embryos number
Measured: up to 1 year
Pregnancies rate
Pregnancies rate
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start14 Jan 2020
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Poor Ovarian ResponseStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barzilai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shevach Friedler, Prof, Barzilai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04024722
- Sponsor's protocol ID
- 0019-18-BRZ
- Status last verified
- Jul 2021
- First submitted
- 3 Jul 2019
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grin L, Berkovitz-Shperling R, Goldstein G, Michailov Y, Gemer O, Anteby E, Kawamura K, Saar-Ryss B, Friedler S. Drug-free in vitro activation of ovarian follicles and fresh tissue autotransplantation in patients with poor ovarian response and premature ovarian insufficiency. F S Sci. 2025 Aug;6(3):303-311. doi: 10.1016/j.xfss.2025.04.002. Epub 2025 Apr 30.
PubMed 40315958
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Results of in Vitro Fertilization in Women With Poor Ovarian Response and Early Ovarian Insufficiency
- ClinicalTrials.gov ID
- NCT04024722
- Acronym / sponsor ID
- 0019-18-BRZ
- Conditions
- Poor Ovarian Response, Ovarian Insufficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Barzilai Medical CenterUniversity, hospital or other
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 18 Jul 2019 (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.
Improving the results of in vitro fertilization in women with poor ovarian response and early ovarian insufficiency
Detailed description
BACKGROUND: Mechanical disruption of the Hippo signaling pathway in the ovaries can increase the likelihood of pregnancy and childbirth in women with early ovarian insufficiency. The method may also "work" in women with poor ovarian reserve and poor response to routine fertility treatments.
OBJECTIVE: To examine whether mechanical stimulation of ovaries by cutting the ovarian cortex treatment can increase eggs number aspirated during In Vitro Fertilization (IVF).
METHODS: Patients eligible for the study with poor ovarian response will receive treatment including laparoscopic surgery, resection, and transplantation of ovarian tissue in the same operation to improve the chances of IVF success and pregnancy. Participants will be assessed for surgical incisions and fertility assessment up to two weeks after treatment, including general physical examination, US pelvic examination, and blood tests for a hormonal profile to determine the initiation of ovarian stimulation and IVF. Patients will be monitored from 2 weeks to 1 year after treatment (once a week in the first two months and one month for one year after surgery), which will include a general physical examination, a pelvic ultrasound (US) and blood tests for the hormonal profile at the IVF clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single ovary treatment | Experimental | Procedure: In Vitro Fertilization |
| Dual ovary treatment | Experimental | Procedure: In Vitro Fertilization |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Volunteers with poor ovarian response to standard fertility treatments according to the criteria of the European Fertility Association (ESHRE).
- Diagnosis of early ovarian insufficiency or symptoms that predict early ovarian insufficiency (imminent) seeking to become pregnant.
Key exclusion criteria (6 listed)
- Volunteers with
- Severe endometriosis diagnosed with laparoscopy.
- Previous major surgery involving ovaries.
- Ovarian cancer.
- Female reproductive malformations.
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 |
|---|---|---|
| In Vitro FertilizationPatients suitable for research with poor ovarian response will receive treatment including laparoscopic surgery, resection, and transplantation of ovarian tissue in the same operation to improve the chances of success of in vitro fertilization and pregnancy. Participants will be assessed for surgical incisions and fertility assessment up to two weeks after treatment, including general physical examination, US pelvic examination, and blood tests for a hormonal profile to determine the initiation of ovarian stimulation and IVF. Patients will be monitored from 2 weeks to 1 year after treatment (once a week in the first two months and one month for one year after surgery), which will include a general physical examination, a US test, and blood tests for the hormonal profile at the IVF clinic. | Procedure or surgery | Dual ovary treatment, Single ovary treatment |
Primary outcome
Number of oocytes
Time frame: up to 1 year
Number of oocytes
Fertilization rate
Time frame: up to 1 year
Fertilization rate
Embryos number
Time frame: up to 1 year
Embryos number
Pregnancies rate
Time frame: up to 1 year
Pregnancies rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Derived from this study: PubMed 40315958Grin L, Berkovitz-Shperling R, Goldstein G, Michailov Y, Gemer O, Anteby E, Kawamura K, Saar-Ryss B, Friedler S. Drug-free in vitro activation of ovarian follicles and fresh tissue autotransplantation in patients with poor ovarian response and premature ovarian insufficiency. F S Sci. 2025 Aug;6(3):303-311. doi: 10.1016/j.xfss.2025.04.002. Epub 2025 Apr 30.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In Vitro Fertilization in people with Poor Ovarian Response and Ovarian Insufficiency, run by Barzilai Medical Center at 1 site in Israel.
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 2 inclusion and 6 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 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of oocytes (time frame: up to 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04024722, which also lists 1 linked publication.
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 28 Jul 2021.