Improving in Vitro Fertilization in Women With Poor Ovarian Response

Poor Ovarian Response Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04024722
• Other study ID #: 0019-18-BRZ
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Ovarian Insufficiency
• Poor Ovarian Response

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