Status
Active, not recruiting
Phase
N/A
Study type
Interventional
Enrollment
3
Sex
Women only
Ages
Ages 18 Years to 40 Years
Primary completion
2026-06-01
Last update
2024-10-23

What this trial studies

Selecting theca and granulosa cells from removed ovaries of BRCA1/2mut patients undergoing Risk-reducing salpingo-oophorectomy (RRSO) and developing a 3D bioprinted hormone-producing bioprosthetic model. If efficacy and tolerability are confirmed in vivo, this bioprosthetic model might be used to replace hormones' production in BRCA mutated patients undergoing prophylactic surgery.

Conditions in scope

  • BRCA Mutation
  • Estrogen Deficiency
  • Surgical Menopause
  • Menopause Related Conditions
  • Menopause, Premature
  • Ovarian Cancer

Interventions

  • Theca and Granulosa Cell Isolation (Procedure) — These patients will receive standard procedure during the risk reducing surgery but their ovaries will be used to extract theca and granulosa cells which will be used for the 3D bioprinted device's realisation.

Who can join

Women only · Ages 18 Years to 40 Years

Inclusion criteria

  • Women between 18-40 years old;
  • BRCA1/2 germline mutations;
  • Completed childbearing;
  • Willing to undergo RRSO;
  • Negative final histological examination;
  • No previous breast cancer.

Exclusion criteria

  • Other malignancies;
  • Final histological examination reporting malignant disease (any);
  • Desire of fertility sparing.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

CityState / RegionFacilitySite status
Rome Day Hospital Tumori Femminili, Policlinico Universitario Fondazione Agostino Gemelli, IRCCS Unknown

Status & timeline

  • Overall status: Active, not recruiting
  • Study type: Interventional
  • Phase: N/A
  • Start date: 2024-10-10
  • Primary completion: 2026-06-01
  • Last update posted: 2024-10-23
  • First posted: 2024-07-11

Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

  • oestrogens and progesterone's levels (minumum 3 months)
    (Unit: pg/mL for both hormones)

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Important. Information from ClinicalTrials.gov as of May 8, 2026. Trial details (status, sites, contacts, eligibility, outcomes) change frequently — always check the official record at https://clinicaltrials.gov/study/NCT06497270 before contacting a site.

ClearedRx is not affiliated with this trial or its sponsor. We index public-domain ClinicalTrials.gov records to help patients find evidence-based context for menopause care decisions. ClearedRx itself is a telehealth menopause/HRT brand — we do not enroll patients in trials.