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Improving in Vitro Fertilization in Women With Poor Ovarian Response

B

Barzilai Medical Center

Status

Unknown

Conditions

Ovarian Insufficiency
Poor Ovarian Response

Treatments

Procedure: In Vitro Fertilization

Study type

Interventional

Funder types

Other

Identifiers

NCT04024722
0019-18-BRZ

Details and patient eligibility

About

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

Full 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.

Enrollment

40 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Single ovary treatment
Experimental group
Treatment:
Procedure: In Vitro Fertilization
Dual ovary treatment
Experimental group
Treatment:
Procedure: In Vitro Fertilization

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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