26 Participants NeededMy employer runs this trial

Utero-ovarian Transposition for Cancer-related Infertility

(UOT WPXRT Trial)

JC
BP
Overseen ByBrittani Powell, MPH, CCRP
Age: < 18
Sex: Female
Trial Phase: Academic
Sponsor: University of South Florida
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new surgery called utero-ovarian transposition for women with pelvic cancers who wish to preserve fertility. The surgery relocates the uterus and ovaries to shield them during radiation treatment. Women needing radiation who want to maintain fertility may be suitable candidates. The study evaluates the procedure's safety and effectiveness by assessing recovery, menstrual health, and quality of life. As an unphased trial, it offers participants the opportunity to contribute to pioneering research that could improve fertility preservation options for future patients.

What prior data suggests that this technique is safe for preserving fertility in women undergoing pelvic radiation therapy?

Earlier research on uterine transposition, part of the utero-ovarian transposition (UOT) technique, has shown promising safety results. Initial findings suggest that this method effectively preserves ovarian function and menstrual cycles. Most patients returned to normal hormone levels and menstrual cycles after surgery, with some achieving successful pregnancies.

One study found that six patients underwent the procedure and maintained normal menstrual function and hormone levels afterward. Another study demonstrated that robotic assistance for uterine transposition was safe and effective in preserving fertility, particularly for patients requiring pelvic radiation.

Overall, these studies provide encouraging evidence that UOT is safe, can be performed with minimal complications, and helps maintain fertility in patients needing pelvic radiation.12345

Why are researchers excited about this trial?

Uteroovarian transposition is unique because it offers a new way to preserve fertility in women undergoing radiotherapy for pelvic cancers. Unlike traditional fertility preservation methods that often involve complex hormonal treatments or egg freezing, this technique uses a minimally invasive surgical approach to relocate the ovaries away from radiation fields, reducing the risk of ovarian damage. Researchers are excited because this could improve reproductive outcomes and quality of life for women without requiring additional reproductive interventions, making it a game-changer in fertility preservation for cancer patients.

What evidence suggests that uterine and ovarian transposition is effective for preserving fertility in cancer-related infertility?

Research has shown that moving the ovaries (utero-ovarian transposition or UOT) can help women maintain fertility despite needing pelvic radiation therapy. This trial will evaluate UOT, which studies have shown to successfully protect ovarian function, with some reporting up to 100% success. Many women have resumed regular menstrual cycles, and some have become pregnant after the procedure. Clinical results also suggest that women can have successful pregnancies after surgery. These findings support UOT as a promising option for preserving fertility in women with pelvic cancers.16789

Who Is on the Research Team?

VA

Vaagn Andikyan

Principal Investigator

USF Health Morsani College of Medicine

Are You a Good Fit for This Trial?

Inclusion Criteria

Normal ovarian function demonstrated by specific hormonal values (FSH <10 IU/L, LH within normal range, AMH >1 ng/mL, E2 within normal range)
Body Mass Index (BMI) <35
Signed informed consent
See 4 more

Exclusion Criteria

Current pregnancy
Other conditions or diagnoses deemed unsuitable by the primary investigator
Signs of poor ovarian reserve (FSH >10 IU/L, AMH <1 ng/mL, Estradiol outside normal range)
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo utero-ovarian transposition (UOT) using a minimally invasive approach

1 week
1 visit (in-person)

Radiation Therapy

Whole pelvic external radiation therapy (WPXRT) is administered to treat pelvic malignancies

6-8 weeks

Follow-up

Participants are monitored for surgical outcomes, hormonal function, menstrual function, and quality of life

52 weeks
Regular visits at 4, 8, 12, and 52 weeks post-surgery

What Are the Treatments Tested in This Trial?

Interventions

  • Uteroovarian Transposition

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Uteroovarian transposition armExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of South Florida

Lead Sponsor

Trials
433
Recruited
198,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40609092/

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