Preservation of Women's Fertility: Evaluation of Innovative Methods for Ovarian Tissue Cryopreservation

NCT06724471 | Active Not Recruiting

• 1 other identifier: 2022_Brugnon_FERTIOVO
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The recent innovations in cancer diagnosis and therapy have improved the five-year survival for patients. However, anticancer treatments may impair patient fertility; therefore fertility preservation is recommended before therapy initiation. The sole method for preserving young prepubescent girls' fertility, which can also be used for pubescent women, is ovarian tissue cryopreservation (OTC) with later auto-transplantation. Although 200 births have been reported worldwide after OTC and transplantation, significant improvements are required. Indeed, freezing and thawing protocols vary according to laboratories (media, cryoprotectants, freezing curve, etc…) and selection criteria are not justified. In addition, most of the laboratories use unsafe devices (e.g. screw cap cryovials) for OTC, exposing ovarian tissues to biological hazards during sample storage in nitrogen tanks. To eliminate these risks, novel "high security" devices have been commercialized (welded cryotubes). However, while thermal welding could alter tissue quality, the functionality of the human ovarian tissue frozen with these innovative devices has not yet been evaluated. The objectives of this study are i) to optimize the freezing and the thawing protocols for human OTC according to thermodynamic properties of the freezing medium and the type of device (welded or screwed cryotube) and ii) to determine if the type of cryotube influences the quality of human ovarian tissue. This project will enable to reach a better understanding of the impact of freezing on ovarian tissue functionality, as well as the implementation of an optimal protocol for OTC within the ART laboratory of Clermont-Ferrand hospital to optimize patient care.

Conditions

Infertility, Female

Keywords

Human ovarian tissue; Cryopreservation; Fertility Preservation; Organotypic culture; Female infertility

Outcome Measures

Primary Outcomes (1)

• Post-thawing Ovarian Follicle morphology

  Follicle morphology of fresh versus frozen (with thermosoldered or screwed cryovials)/thawed ovarian cortex will be assessed on serial sections stained with hematoxylin-eosin-saffron. Fragments will be fixed on the day of collection for group 1 and directly after thawing for groups 2 and 3. Morphology of follicles will be evaluated according to the parameters described by Keros et al. Hum Reprod. 2009.

  24 months

Secondary Outcomes (11)

• Post-thawing Ovarian Follicle density

  24 months

• Post-thawing Ovarian Follicle proliferation

  24 months

• Post-thawing Ovarian Follicle apoptosis

  24 months

• Ovarian Follicle stage after organotypic culture

  36 months

• Ovarian Follicle morphology after organotypic culture

  36 months

Study Arms (3)

Fresh ovarian cortex fragments

Pericystic ovarian cortex will be cut into 1mm3 fragments and either directly analyzed on the day of collection (D0) or after organotypic culture (D7 and D14).

Fragments of ovarian cortex frozen in thermosoldered cryovials.

Pericystic ovarian cortex will be cut into 1mm3 fragments, frozen using a slow programmable freezing device (Nano Digitcool, Cryo Bio System) in thermosoldered cryovials and stored in liquid nitrogen (-196°C). Then, fragments will be thawed before being analyzed on the day of thawing (D'0) and after 7 and 14 days (D7 and D14) of organotypic culture.

Device: Human ovarian tissue cryopreservation using thermosoldered or screwed cryovials

Fragments of ovarian cortex frozen in screwed cryovials.

Pericystic ovarian cortex will be cut into 1mm3 fragments, frozen using a slow programmable freezing device (Nano Digitcool, Cryo Bio System) in screwed cryovials and stored in liquid nitrogen (-196°C). Then fragments will be thawed before being analyzed on the day of thawing (D'0) and after 7 and 14 days (D7 and D14) of organotypic culture.

Device: Human ovarian tissue cryopreservation using thermosoldered or screwed cryovials

Interventions

Human ovarian tissue cryopreservation using thermosoldered or screwed cryovials DEVICE

Human ovarian tissue Cryopreservation: immediately after cyst resection, pericystic ovarian cortex will be cut into 1mm3 fragments and cryopreserved in screwed or thermosoldered cryovials using a slow programmable freezing device (Nano Digitcool, Cryo Bio System).

Fragments of ovarian cortex frozen in screwed cryovials.; Fragments of ovarian cortex frozen in thermosoldered cryovials.

Eligibility Criteria

• Age: 18 Years - 37 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adult woman scheduled for benign ovarian cyst resection in the University Hospital Center of Clermont-Ferrand.

You may qualify if:

• Adult woman scheduled for benign ovarian cyst resection (dermoid, functional, mucinous or serous cysts)
• Below 37 years old and above 18 years old
• Capable of giving written informed consent to participate in the research study
• Affiliated to social welfare service

You may not qualify if:

• Women above 37 years old and below 18 years old
• Polycystic ovary syndrome
• Diminished ovarian reserve
• Severe endometriosis
• Malignant and endometrial cysts

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• CryoBioSystem: collaborator
• IMoST UMR 1240 Inserm-Université Clermont Auvergne: collaborator

Study Sites (1)

University Hospital

Clermont-Ferrand, 63100, France

Location

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Officials

• Florence Brugnon, MD, PhD

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 9, 2024
• Study Start: May 5, 2022
• Primary Completion: June 1, 2025
• Study Completion: December 31, 2025
• Last Updated: June 29, 2025

Record last verified: 2025-06

Locations

FR (1)