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NCT05462379Active, not recruitingPhase 1/2

Autologous Heterotopic Fresh Ovarian Graft in Woman With LACC Eligible for Pelvic Radiotherapy Treatment.

Autologous Heterotopic Fresh Ovarian Graft in Young Woman With Locally Advanced Cervical Cancer Eligible for Pelvic Radiotherapy Treatment

Source: ClinicalTrials.gov · Last updated 5 Sept 2025

Brief summary (registry, in English)

Pelvic chemoradiotherapy (CRT) is an effective treatment for Locally Advanced Cervical Cancer (LACC). However, CRT induces premature ovarian failure ceasing the production of ovarian hormones. This may lead to severe consequences to the patient's life quality, sexuality and overall healthy. An acceptable treatment to minimize the adverse effects caused by the lack of ovarian hormones is hormonal replacement but less than 40% of the patients younger than 50 years have access to this treatment. A second alternative treatment is ovarian transposing which is a surgical technique with variable success rate depending on how far the ovaries are from the radiotherapy field. A third, more promising, alternative is involves using autologous ovarian tissue as a graft in tissues far from the radiotherapy field. This treatment has the potential of maintaining the natural ovarian hormones production at a lower-cost and requiring a simpler procedure. The primary objective of this randomized phase 1-2 clinical trial is to validate the feasibility of ovarian tissue engraft into fatty tissue and its endocrine functionality.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
22 (actual)
First submitted
9 Jun 2022
Start date
8 Jun 2022
Primary completion date
1 Apr 2025
Lead sponsor
MARILIA ALBANEZI BERTOLAZZI
NCT number
NCT05462379

What you commit to

  • Study type: Interventional · Phase 1/2
  • Participants enrolled: 22
  • From 8 Jun 2022 to the primary completion date, 1 Apr 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous treatment for cervical cancer or other malignant diseases.

Other

  • Rare histology tumors.
  • Absence of one or both ovaries.

Who the study is looking for

  • Pathologic diagnosis of squamous cell carcinoma or adenocarcinoma of the cervix.
  • FIGO 2018 staging IB3 to IVA.
  • Absence of ovarian involvement.
  • Age ≤35 Years.
  • Absence of metastatic disease.
  • Written consent.

Age in the registry: 18 years to 35 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Instituto do Câncer do Estado de São Paulo
Coordinator of this site? Confirm its status
São PauloBrazilUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.