Autologous Ovarian Tissue Transplantation

NCT03496636 | Recruiting DMC

• 1 other identifier: STUDY19050305
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Keywords

Ovary; Transplant

Outcome Measures

Primary Outcomes (3)

• Change in reproductive hormone levels after ovarian tissue transplant

  Measure of reproductive hormone levels (FSH, AMH, LH E2 and others) to detect graft function

  1,3,6,9,12 and 24 months post-transplantation

• Return of regular monthly menstrual cycles

  Onset of regular monthly menstrual cycles after transplantation would indicate graft function. This needs to be analyzed at multiple time points to assess if regular monthly menstrual cycles have ceased, which could indicate graft failure.

  Through study completion, up to 15 years

• Achievement of successful pregnancy, measured by live birth

  Indicates recovery of ovarian function

  Through study completion, up to 15 years

Secondary Outcomes (3)

• Cancer recurrence as determined by patient's oncologist

  Through study completion, up to 15 years

• Surgical complications of ovarian tissue transplantation

  1,3,6,9,12 and 24 months post-transplantation

• Fertility quality of life (FertiQoL) survey results

  1,3,6,9,12 and 24 months post-transplantation

Study Arms (1)

Ovarian tissue transplant

EXPERIMENTAL

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

Procedure: Ovarian tissue transplant

Interventions

Ovarian tissue transplant PROCEDURE

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

Ovarian tissue transplant

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Officials

• Kyle Orwig, PhD

  University of Pittsburgh/University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Anglin

CONTACT

412-641-7475; fertilitypreservation@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: April 12, 2018
• Study Start: March 1, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: We will share IPD with the patient (and only the patient) within one year of enrollment. We share study protocol and ICF with collaborating sites upon request. De-identified IDP is shared with collaborating sites annually.
• Access Criteria: De-identified research data will be shared with collaborators via e-mail, and with the broader scientific community via publication and presentations at national/international meetings.

Locations

US (1)