Improving in Vitro Fertilization in Women With Poor Ovarian Response

NCT04024722 | Unknown

• 1 other identifier: 0019-18-BRZ
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Poor Ovarian Response; Ovarian Insufficiency

Outcome Measures

Primary Outcomes (4)

• Number of oocytes

  Number of oocytes

  up to 1 year

• Fertilization rate

  Fertilization rate

  up to 1 year

• Embryos number

  Embryos number

  up to 1 year

• Pregnancies rate

  Pregnancies rate

  up to 1 year

Study Arms (2)

Single ovary treatment

EXPERIMENTAL

Procedure: In Vitro Fertilization

Dual ovary treatment

EXPERIMENTAL

Procedure: In Vitro Fertilization

Interventions

In Vitro Fertilization PROCEDURE

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.

Dual ovary treatment; Single ovary treatment

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Volunteers with
• Severe endometriosis diagnosed with laparoscopy.
• Previous major surgery involving ovaries.
• Ovarian cancer.
• Female reproductive malformations.
• Contraindications for laparoscopic surgery.

Sponsors & Collaborators

• Barzilai Medical Center: lead

Study Sites (1)

Barzilay University Medical Center

Ashkelon, Israel

RECRUITING

Related Publications (1)

• Grin L, Berkovitz-Shperling R, Goldstein G, Michailov Y, Gemer O, Anteby E, Kawamura K, Saar-Ryss B, Friedler S. Drug-free in vitro activation of ovarian follicles and fresh tissue autotransplantation in patients with poor ovarian response and premature ovarian insufficiency. F S Sci. 2025 Aug;6(3):303-311. doi: 10.1016/j.xfss.2025.04.002. Epub 2025 Apr 30.

  PMID: 40315958 DERIVED

MeSH Terms

Interventions

Fertilization in Vitro

Intervention Hierarchy (Ancestors)

Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of IVF unit

Study Record Dates

• First Submitted: July 3, 2019
• First Posted: July 18, 2019
• Study Start: January 14, 2020
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2022
• Last Updated: July 28, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)