Preservation of Women's Fertility: Evaluation of Innovative Methods for Ovarian Tissue Cryopreservation
Key facts
- Who runs it
- University Hospital, Clermont-Ferrand
- Where
- France1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 30 people enrolled
- Started
- 5 May 2022
- Ended
- 31 Dec 2025
- Type of study
- Observational, 3 groups
- Treatments tested
- Human ovarian tissue cryopreservation using thermosoldered or screwed cryovials
- Record updated
- 29 June 2025
Who can take part
- Age
- 18 years to 37 years
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- Polycystic ovary syndrome
- Malignant and endometrial cysts
- Women above 37 years old and below 18 years old
- Diminished ovarian reserve
- Severe endometriosis
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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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.
The 3 groups in the trial
- 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.
Treatment: 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.
Treatment: Human ovarian tissue cryopreservation using thermosoldered or screwed cryovials
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 29 June 2025