Fertility Preservation, Oncological Disease
Conditions
Brief summary
Most medically assisted procreation (ART) techniques, including oocyte cryopreservation for fertility preservation, involve controlled ovarian stimulation. This procedure uses exogenous hormones, primarily follicle-stimulating hormone (FSH), to promote the development of multiple ovarian follicles in a single menstrual cycle. Once follicles reach a suitable number and size, oocyte retrieval (pick-up) is scheduled after pharmacological ovulation induction. Human chorionic gonadotropin (hCG) has been routinely used for ovulation induction, but a common complication is ovarian hyperstimulation syndrome (OHSS). Studies have shown that in antagonist protocols, using a gonadotropin-releasing hormone agonist (GnRH-a) instead of hCG reduces OHSS risk. However, GnRH-a triggers luteal phase dysfunction, likely due to depletion of pituitary LH reserves and lack of LH-like activity (present in hCG), resulting in lower clinical pregnancy rates and occasionally very low oocyte yield. To maximize oocyte retrieval and minimize OHSS risk, a combined "dual trigger" approach using both GnRH-a and hCG has been proposed, leveraging benefits of both agents. Currently, limited data exist regarding the optimal ovulation induction strategy in oncological patients undergoing fertility preservation via oocyte cryopreservation before gonadotoxic therapy, where maximizing outcomes and minimizing complications is critical. This study aims to compare the number of oocytes retrieved per cycle in oncological patients undergoing fertility preservation with ovulation induced by either GnRH-a alone or dual trigger (GnRH-a + hCG). It will also assess the oocyte retrieval rate (number of oocytes retrieved/number of follicles aspirated), number of mature oocytes, and incidence of moderate OHSS within 7 days post-retrieval in both groups. Additionally, it will explore correlations between serum estradiol (E2) and luteinizing hormone (LH) levels on the trigger day and oocyte yield. Approximately 200 patients aged ≥18 years will be consecutively enrolled over 2 years and 2 months. Retrospective period considered: from January 1, 2023, to the study initiation date. Patients will be assigned by clinicians to one of two groups based on clinical characteristics: Group 1: Ovulation induced with 0.2 mg subcutaneous triptorelin (Decapeptyl®) Group 2: Ovulation induced with 0.2 mg subcutaneous triptorelin plus 1000-5000 IU urinary hCG (Gonasi®) Treatment follows standard clinical practice.
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 * AMH \> 1.00 ng/mL * Obtaining written informed consent to participate in the study and for data processing
Exclusion criteria
* Hypersensitivity to one or more of the active substances used during the treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of oocytes retrieved | During oocyte retrieval procedure | Oocyte retrieval count |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oocyte retrieval rate | 2 hours after oocyte retrieval | Number of oocytes retrieved / number of aspirated follicles |
| Number of mature oocytes (number of metaphase II oocytes) | 2 hours after oocyte retrieval | Count of retrieved metaphase II oocytes |
| Patients who develop OHSS | Within 7 days after oocyte retrieval | Number of patients presenting with moderate-grade ovarian hyperstimulation syndrome (OHSS), defined as the presence of ascites, maximum ovarian diameter ≥ 8 cm, hematocrit ≥ 45%, abdominal pain, abdominal distension, or dyspnea |
| Correlation between E2 levels and number of oocytes retrieved | 2 hours after oocyte retrieval | Count of oocytes retrieved |
Countries
Italy
Contacts
CONTACTGiulia Borghese, MD
Outcome results
None listed