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Procedure

Autologous Ovarian Tissue Transplant for Infertility

N/A
Recruiting
Led By Kyle Orwig, PhD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Previously cryopreserved ovarian tissue
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 15 years
Awards & highlights

Study Summary

This trial is studying whether it is safe to give patients their own frozen ovarian tissue after chemotherapy and/or radiation treatments for cancer.

Who is the study for?
This trial is for women who have lost their fertility due to cancer treatments like chemotherapy or radiation and had previously frozen ovarian tissue. They must be in good health, cleared by an oncologist, and either have primary ovarian insufficiency or wish to become pregnant. Women at high surgical risk, with pregnancy contraindications, BRCA mutations, certain cancers, psychological issues preventing consent, or current pregnancy cannot join.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of transplanting a woman's own previously frozen ovarian tissue back into her body. This procedure aims to restore fertility in women who became infertile after receiving cancer treatment.See study design
What are the potential side effects?
Potential side effects may include typical risks associated with surgical procedures such as infection, bleeding, pain at the transplantation site; hormonal changes; and possible failure to restore fertility.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have my ovarian tissue frozen.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to 15 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 15 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Achievement of successful pregnancy, measured by live birth
Change in reproductive hormone levels after ovarian tissue transplant
Return of regular monthly menstrual cycles
Secondary outcome measures
Cancer recurrence as determined by patient's oncologist
Fertility quality of life (FertiQoL) survey results
Surgical complications of ovarian tissue transplantation

Trial Design

1Treatment groups
Experimental Treatment
Group I: Ovarian tissue transplantExperimental Treatment1 Intervention
Transplantation of ovarian tissue into the abdomen. Only for patients who have previously frozen ovarian tissue

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,722 Previous Clinical Trials
16,342,931 Total Patients Enrolled
1 Trials studying Primary Ovarian Insufficiency
13 Patients Enrolled for Primary Ovarian Insufficiency
Kyle Orwig, PhDPrincipal Investigator - University of Pittsburgh/University of Pittsburgh Medical Center
University of Pittsburgh
7 Previous Clinical Trials
1,926 Total Patients Enrolled

Media Library

Ovarian tissue transplant (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03496636 — N/A
Primary Ovarian Insufficiency Research Study Groups: Ovarian tissue transplant
Primary Ovarian Insufficiency Clinical Trial 2023: Ovarian tissue transplant Highlights & Side Effects. Trial Name: NCT03496636 — N/A
Ovarian tissue transplant (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03496636 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are recruitment efforts still ongoing for this trial?

"Affirmative. According to clinicaltrials.gov, this medical trial commenced on March 1st 2021 and is still in progress, as it was recently updated on May 19th 2022. The study requires five patients from a single site."

Answered by AI

What are the criteria necessary for someone to participate in this trial?

"For this clinical experiment, only 5 participants aged between 18 and 45 who have primary ovarian insufficiency can be accepted. Furthermore, they must meet the following requirements: Possess previously cryopreserved ovarian tissue; Have an episode of ovarian inadequacy or wish to become pregnant; Be in good health condition & receive a clearance from their oncologist."

Answered by AI

Is participation in this medical study open to adults 18 years and older?

"This clinical trial is only open to individuals aged 18-45 years old. For those under the age of 18, there are a total 19 trials available and for patients over 65, 36 different studies remain accessible."

Answered by AI

What is the cap on enrollment for this research project?

"Affirmative. Clinicaltrials.gov confirms that this research study, which was initially launched on March 1st 2021, is still recruiting participants. The clinical trial needs to recruit 5 individuals from one medical centre."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Autologous Ovarian Tissue Transplantation
Kyle Orwig 2021. "Autologous Ovarian Tissue Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03496636.
All > Premature Ovarian Failure > Infertility
~2 spots leftby Sep 2026
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