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

NCT ID: NCT05462379

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-08
• Study Completion Date: 2027-04-01

Brief Summary

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.

Conditions

Locally Advanced Cervical Carcinoma; Premature Ovarian Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard treatment

10 patients: Pelvic Chemoradiotherapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Ovarian Graft

10 patients: Before the beginning of pelvic radiotherapy, one of the ovaries will be removed by laparoscopy. Ovary slices of 1-2 mm will be prepared in sterile environment and engrafted in the fatty tissue of inner tight. One representative fragment will undergo histologic evaluation. These procedures will be done in the same surgical time.

Group Type: EXPERIMENTAL

Ovarian graft

Intervention Type: PROCEDURE

Before the beginning of pelvic radiotherapy, one of the ovaries will be removed by laparoscopy. Ovary slices of 1-2 mm will be prepared in sterile environment and engrafted in the fatty tissue of inner tight. One representative fragment will undergo histologic evaluation. These procedures will be done in the same surgical time.

Interventions

Ovarian graft

Before the beginning of pelvic radiotherapy, one of the ovaries will be removed by laparoscopy. Ovary slices of 1-2 mm will be prepared in sterile environment and engrafted in the fatty tissue of inner tight. One representative fragment will undergo histologic evaluation. These procedures will be done in the same surgical time.

Intervention Type: PROCEDURE

Other Intervention Names

Autologous Heterotopic Fresh Ovarian Graft

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Previous treatment for cervical cancer or other malignant diseases.
• Rare histology tumors.
• Absence of one or both ovaries.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

MARILIA ALBANEZI BERTOLAZZI

OTHER

Sponsor Role: lead

Responsible Party

MARILIA ALBANEZI BERTOLAZZI

Principal investigator/ Gynaecologist

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Instituto do Cancer do Estado de São Paulo

São Paulo, , Brazil

Countries

Brazil

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

NP1782

Identifier Type: -

Identifier Source: org_study_id