Fertility Preservation, Oncological Disease
Conditions
Brief summary
Fertility preservation is a crucial aspect of care for oncological patients undergoing gonadotoxic treatments such as chemotherapy, radiotherapy, or surgery, which can significantly reduce ovarian reserve and cause infertility or premature menopause. Among available techniques, oocyte cryopreservation is well-established with high survival rates but requires controlled ovarian stimulation and may not be suitable for prepubertal patients or those needing urgent cancer therapy. Ovarian tissue cryopreservation offers advantages by preserving a larger number of primordial follicles, can be performed anytime in the menstrual cycle regardless of age, and also helps restore ovarian endocrine function. Combining ovarian tissue cryopreservation followed by oocyte cryopreservation may maximize fertility preservation by safeguarding more follicles and ensuring availability of mature oocytes. This study will collect data from two patient groups: Group 1: patients undergoing ovarian tissue cryopreservation followed by oocyte cryopreservation (combined treatment) Group 2: patients undergoing oocyte cryopreservation alone. Group assignment is based on planned gonadotoxic therapy and available time before treatment initiation, according to clinical practice. The study aims to compare the number of oocytes retrieved per ovarian stimulation cycle between the two groups, along with the oocyte retrieval rate (number of oocytes retrieved/number of aspirated follicles), number of mature oocytes (metaphase II), incidence of moderate ovarian hyperstimulation syndrome within 7 days post-retrieval, and correlations between serum estradiol and luteinizing hormone levels on trigger day and oocyte yield. Approximately 127 patients aged 18 to 46 will be consecutively enrolled at the UO Gynecology and Human Reproduction Pathophysiology, IRCCS AOUBO Policlinico di Sant'Orsola. This is a cross-sectional, single-center, observational study with both retrospective and prospective enrollment. The retrospective period considered is from January 1, 2022, to the study start date. The study duration is 4 years and 3 months.
Interventions
None listed
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 46 Years
Healthy volunteers
No
Inclusion criteria
* Patient with oncological disease eligible for potentially gonadotoxic therapy * BMI ≥ 17.5 kg/m² and ≤ 32 kg/m² * Age ≥ 18 years and ≤ 46 years
Exclusion criteria
* Hypersensitivity to one or more of the active substances used during ovarian stimulation treatment * Positive for HBV, HCV, HIV, or Treponema pallidum * Lack of oncological clearance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the number of oocytes retrieved per stimulation cycle in oncology patients undergoing fertility preservation before gonadotoxic therapy: ovarian tissue cryopreservation followed by oocyte cryopreservation vs. oocyte cryopreservation alone | 2 hours after oocyte retrieval | Count of oocytes retrieved |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To compare the oocyte retrieval rate (number of oocytes retrieved / number of aspirated follicles) between the two previously described patient groups. | 2 hours after oocyte retrieval | Number of oocytes retrieved / number of aspirated follicles |
| To compare the number of mature oocytes retrieved (defined as the number of metaphase II oocytes) between the two groups. | 2 hours after oocyte retrieval | Count of retrieved metaphase II oocytes |
| To compare the number of patients who develop moderate ovarian hyperstimulation syndrome (OHSS) (defined by presence of ascites, maximum ovarian diameter ≥ 8 cm, hematocrit ≥ 45%, symptoms such as abdominal pain, abdominal distension, or dyspne | Within 7 days after oocyte retrieval. | Number of patients presenting with moderate or severe ovarian hyperstimulation syndrome (OHSS) (defined by the presence of ascites, maximum ovarian diameter ≥ 8 cm, hematocrit ≥ 45%, symptoms including abdominal pain, abdominal distension, and dyspnea) |
| To assess whether increasing serum levels of estradiol (E2) (pg/mL) and luteinizing hormone (LH), measured on the day of ovulation trigger, correspond to a higher number of oocytes retrieved in the two previously described patient groups. | 2 hours after oocyte retrieval] | Estradiol (E2) measured in pg/mL / number of oocytes retrieved |
| To compare the number of patients who develop hemoperitoneum and/or pelvic infections between the two groups. | Within 7 days after oocyte retrieval | Development of hemoperitoneum and/or pelvic infections |
Countries
Italy
Contacts
CONTACTDiego Raimondo, MD
Outcome results
None listed