IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138, Italy
Location status: Recruiting
NCT Number: NCT07546123
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.
Interested in participating?
Request Info18 year–46 year
Female
Observational
Bologna, 40138, Italy
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 2 hours after oocyte retrieval
Count of oocytes retrieved
Time frame: 2 hours after oocyte retrieval
Number of oocytes retrieved / number of aspirated follicles
Time frame: 2 hours after oocyte retrieval
Count of retrieved metaphase II oocytes
Time frame: 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)
Time frame: 2 hours after oocyte retrieval]
Estradiol (E2) measured in pg/mL / number of oocytes retrieved
Time frame: Within 7 days after oocyte retrieval
Development of hemoperitoneum and/or pelvic infections
Contact information is provided by the study sponsor or research team.
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Other
Ovarian Tissue Cryopreservation Combined With Oocyte Cryopreservation Versus Oocyte Cryopreservation Alone: an Observational Study in Oncology Patients
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07546136
Fertility Preservation, Oncological Disease
Bologna, Italy
View Trial DetailsNCT05885048
Cancer, Effects of Immunotherapy
Bern, Switzerland
View Trial DetailsNCT02895165
Breast Diseases, Breast Neoplasms
Asti, Italy
View Trial DetailsNCT07225660
Fertility Preservation
Orange, Connecticut, United States
View Trial Details