About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial 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
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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
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
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)
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
Sponsors and contacts
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