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

Condition(s) studied

Study 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

Primary outcome measure(s)

• Causes and factors that influence the low rate of reimplantation of ovarian tissue — At least 5 years after surgery at first follow-up
  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 — At least 5 years after surgery at first follow-up
  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 — At least 5 years after surgery at first follow-up
  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 — At least 5 years after surgery at first follow-up
  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
• Early ovarian failure — At least 5 years after surgery at first follow-up
  Effects of early ovarian failure in this category of women, particularly in terms of Middlesex Hospital Questionnaire (MHQ), score: \<23: normal; \>= 23: abnormal
• Early ovarian failure — At least 5 years after surgery at first follow-up
  Effects of early ovarian failure in this category of women, particularly in terms of psychological function through Beck's Depression Inventory, score: 0-63

Trial sites (1)

More IRCCS Azienda Ospedaliero-Universitaria di Bologna trials in Italy

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