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Clinical Trials/NCT04024722
NCT04024722
Unknown
Not Applicable

Improving the Results of in Vitro Fertilization in Women With Poor Ovarian Response and Early Ovarian Insufficiency

Barzilai Medical Center1 site in 1 country40 target enrollmentJanuary 14, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Poor Ovarian Response
Sponsor
Barzilai Medical Center
Enrollment
40
Locations
1
Primary Endpoint
Number of oocytes
Last Updated
4 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 14, 2020
End Date
July 31, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Shevach Friedler, Prof

Director of IVF unit

Barzilai Medical Center

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Number of oocytes

Time Frame: up to 1 year

Number of oocytes

Embryos number

Time Frame: up to 1 year

Embryos number

Fertilization rate

Time Frame: up to 1 year

Fertilization rate

Pregnancies rate

Time Frame: up to 1 year

Pregnancies rate

Study Sites (1)

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