Recruiting

Autologous Ovarian Tissue

Sponsor:

University of Pittsburgh

Code:

NCT03496636

Conditions

Female Infertility

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Ovarian tissue transplant

Study Details

Brief summary:

Chemotherapy and radiation for cancer and other conditions can cause infertility. Several centers around the world are cryopreserving ovarian tissue from these patients though an experimental protocol, including the Fertility Preservation Program in Pittsburgh (protocol PRO08050491). The objective of this study is to study the efficacy and safety of autologous tissue transplantation in patients diagnosed with primary ovarian insufficiency after chemotherapy and/or radiation treatments.

Conditions

Female Infertility

Study ID

NCT03496636

Start date

Mar 1, 2021

Status verified date

Jul, 2026

Completion date

Sep 1, 2030

Anticipated

Primary completion date

Sep 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Previously cryopreserved ovarian tissue
  • Ovarian insufficiency and/or candidate for pregnancy
  • Good health
  • Oncologist's clearance

Exclusion Criteria:

  • Patients considered to be high risk for surgical complications
  • Women with contraindication for pregnancy if goal is to achieve pregnancy
  • Women positive for the BRCA mutations
  • Women with a history of leukemia, ovarian cancer or a cancer that likely involved ovaries at the time of ovarian tissue collection
  • Women with psychological, psychiatric, or other conditions which prevent giving fully informed consent
  • Current pregnancy

Study Design

Enrollment

5 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ovarian tissue transplant

Transplantation of ovarian tissue into the abdomen. Only for patients who have previously frozen ovarian tissue

Interventions

Ovarian tissue transplant

Pieces of previously frozen ovarian cortex will be put in the abdomen laparoscopically, or with mini laparotomy

Primary outcome measure

  • Change in reproductive hormone levels after ovarian tissue transplant [ Time Frame: 1,3,6,9,12 and 24 months post-transplantation ]
  • Return of regular monthly menstrual cycles [ Time Frame: Through study completion, up to 15 years ]
  • Achievement of successful pregnancy, measured by live birth [ Time Frame: Through study completion, up to 15 years ]

Central Contacts and Locations

Central contacts

Jennifer Anglin

412-641-7475fertilitypreservation@upmc.edu

Locations

Magee-Womens Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Jennifer Anglin

412-641-7475fertilitypreservation@upmc.edu

More Information

Sponsor

University of Pittsburgh

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Keywords

  • Ovary
  • Transplant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-07-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.