Cryopreservation Of Ovarian Tissue: Assessment Of Reimplantation Rate And Effects On Ovarian Function

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 13
Maximum Age: 55
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna
RECRUITING
Bologna
Contact Information
Primary
Renato Seracchioli, MD
renato.seracchioli@aosp.bo.it
+390512143944
Backup
Rossella Vicenti
rossella.vicenti@unibo.it
Time Frame
Start Date: 2021-09-12
Estimated Completion Date: 2031-12-30
Participants
Target number of participants: 400
Related Therapeutic Areas
Sponsors
Leads: IRCCS Azienda Ospedaliero-Universitaria di Bologna

This content was sourced from clinicaltrials.gov