Improving in Vitro Fertilization in Women With Poor Ovarian Response

Not Applicable

• Conditions: Poor Ovarian Response; Ovarian Insufficiency
• Interventions: Procedure: In Vitro Fertilization

• Registration Number: NCT04024722
• Lead Sponsor: Barzilai Medical Center

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 Timeline

• Study First Submitted: 2019-07-03
• Study First Submitted QC: 2019-07-17
• Study First Posted: 2019-07-18
• Study Start: 2020-01-14
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-27
• Last Update Posted: 2021-07-28
• Primary Completion: 2021-07-31
• Study Completion: 2022-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dual ovary treatment	In Vitro Fertilization	-
Single ovary treatment	In Vitro Fertilization	-

Primary Outcome Measures

Name	Time	Method
Number of oocytes	up to 1 year	Number of oocytes
Embryos number	up to 1 year	Embryos number
Fertilization rate	up to 1 year	Fertilization rate
Pregnancies rate	up to 1 year	Pregnancies rate

Trial Locations

Locations (1)

Barzilay University Medical Center; 🇮🇱 Ashkelon, Israel