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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04024722
Other study ID # 0019-18-BRZ
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 14, 2020
Est. completion date July 31, 2022

Study information

Verified date July 2021
Source Barzilai Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date July 31, 2022
Est. primary completion date July 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
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.

Locations

Country Name City State
Israel Barzilay University Medical Center Ashkelon

Sponsors (1)

Lead Sponsor Collaborator
Barzilai Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of oocytes Number of oocytes up to 1 year
Primary Fertilization rate Fertilization rate up to 1 year
Primary Embryos number Embryos number up to 1 year
Primary Pregnancies rate Pregnancies rate up to 1 year
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