Improving in Vitro Fertilization in Women With Poor Ovarian Response

NCT ID: NCT04024722

Last Updated: 2021-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-14

Study Completion Date

2022-07-31

Brief Summary

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Improving the results of in vitro fertilization in women with poor ovarian response and early ovarian insufficiency

Detailed Description

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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

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Poor Ovarian Response Ovarian Insufficiency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single ovary treatment

Group Type EXPERIMENTAL

In Vitro Fertilization

Intervention Type PROCEDURE

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.

Dual ovary treatment

Group Type EXPERIMENTAL

In Vitro Fertilization

Intervention Type PROCEDURE

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.

Interventions

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In Vitro Fertilization

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

Volunteers with

* Severe endometriosis diagnosed with laparoscopy.
* Previous major surgery involving ovaries.
* Ovarian cancer.
* Female reproductive malformations.
* Contraindications for laparoscopic surgery.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Barzilai Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Shevach Friedler, Prof

Director of IVF unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Barzilay University Medical Center

Ashkelon, , Israel

Site Status RECRUITING

Countries

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Israel

Facility Contacts

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Shevach Friedler, Proffesor

Role: primary

972 8 6748882

Yaniv Ovadia, Doctor

Role: backup

972 8 6745220

References

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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.

Reference Type DERIVED
PMID: 40315958 (View on PubMed)

Other Identifiers

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0019-18-BRZ

Identifier Type: -

Identifier Source: org_study_id

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