Cryopreservation of Ovarian Tissue: Reimplantation Rate and Effects on Ovarian Function

NCT06835088 | Recruiting

• 1 other identifier: CRIO-2021
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Premature ovarian failure (POI) is a clinical syndrome defined by the loss of ovarian activity before age 40. POI is characterized by amenorrhea or oligomenorrhea with elevated gonadotropins, low estradiol and serious consequences on fertility. The prevalence of POI in the general population is about 1%. In recent years, the incidence of iatrogenic POI in cancer women is increasing: 4% of patients of fertile age are diagnosed with neoplasms and gonadal treatments that can sterilize them, such as chemotherapy and radiotherapy. Preserving fertility is a key objective for many cancer patients. Before gonadotoxic treatments, patients in the post-pubertal age with future desire for pregnancy may opt for two main methods of preservation of fertility (FP): egg cryopreservation (OC) after ovarian stimulation and cryopreservation of ovarian tissue (OTC). An important limitation of the latter technique is the reduced number of patients who return to use the cryopreserved material, leading to a negative impact on the evaluation of the effectiveness of the procedure. The best way to maximise the effectiveness of the procedure in clinical and economic terms would be to increase the number of patients who continue the cryopreservation path by completing it with subsequent reimplantation. It would also be useful to improve the follow-up of these patients by evaluating their ovarian function over time, before and after the removal and reimplantation, through the study of bone metabolism, cardiovascular risk and psychological function in these women.

Conditions

Cryopreservation

Keywords

cryopreservation; ovarian tissue; ovarian function

Outcome Measures

Primary Outcomes (6)

• Causes and factors that influence the low rate of reimplantation of ovarian tissue

  Investigate the causes and factors that influence the low rate of reimplantation of ovarian tissue after the phase of collection and cryopreservation

  At least 5 years after surgery at first follow-up

• Early ovarian failure

  Effects of early ovarian failure in this category of women, particularly in terms of bone metabolism (through Bone densitometry with a dual-energy x-ray absorptiometry, DEXA, Z-score. BMD:\> -2.0 normal; ≤ -2.0:osteoporosi

  At least 5 years after surgery at first follow-up

• Early ovarian failure

  Effects of early ovarian failure in this category of women, particularly in terms of cardiovascular risk (through ACC/AHA Cardiovascular Risk Calculator, %: \<5%: low risk; 5-7.4%: Borderline risk; 7.5-19.9%: intermediate risk; ≥20%: high risk)

  At least 5 years after surgery at first follow-up

• Early ovarian failure

  Effects of early ovarian failure in this category of women, particularly in terms of psychological function (through Short Form36 HealthSurvey (SF-36), score: 0-100

  At least 5 years after surgery at first follow-up

• Early ovarian failure

  Effects of early ovarian failure in this category of women, particularly in terms of Middlesex Hospital Questionnaire (MHQ), score: \<23: normal; \>= 23: abnormal

  At least 5 years after surgery at first follow-up

• Early ovarian failure

  Effects of early ovarian failure in this category of women, particularly in terms of psychological function through Beck's Depression Inventory, score: 0-63

  At least 5 years after surgery at first follow-up

Eligibility Criteria

• Age: 13 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women aged between 13 and 55 years old suffering from oncological pathologies that require gonadotoxic treatments and who undergo prior to these treatments a collection of ovarian tissue for cryopreservation and possible subsequent orthotopic or heterotropic reimplantation in order to restore ovarian function and fertility

You may qualify if:

• Age: 13-55 years
• Suffering from diseases that require gonadotropic treatments
• Have been subjected to sampling and cryopreservation of ovarian tissue at the Operative Unit of Gynecology and Pathophysiology of Human Reproduction of the Sant'Orsola Polyclinic in Bologna
• Informed Consent Acquisition

You may not qualify if:

• \- Oncological pathology still active or relapse

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

Study Officials

• Renato Seracchioli, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Renato Seracchioli, MD

CONTACT

+390512143944; renato.seracchioli@aosp.bo.it

Rossella Vicenti

CONTACT

rossella.vicenti@unibo.it

Study Design

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

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: February 19, 2025
• Study Start: September 12, 2021
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 30, 2031
• Last Updated: February 19, 2025

Record last verified: 2024-11

Locations

IT (1)