Improving the Results of in Vitro Fertilization in Women With Poor Ovarian Response and Early Ovarian Insufficiency
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Barzilai Medical Center
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Number of oocytes
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Shevach Friedler, Prof
Director of IVF unit
Barzilai Medical Center