Ovulation Induction With GnRH Analogue or Dual Trigger?
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Oncological Disease, Fertility Preservation. Basic parameters: 18 years — 46 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Number of oocytes retrieved [Time frame: During oocyte retrieval procedure]
Secondary outcome measures (4)
- Oocyte retrieval rate [Time frame: 2 hours after oocyte retrieval]
- Number of mature oocytes (number of metaphase II oocytes) [Time frame: 2 hours after oocyte retrieval]
- Patients who develop OHSS [Time frame: Within 7 days after oocyte retrieval]
- Correlation between E2 levels and number of oocytes retrieved [Time frame: 2 hours after oocyte retrieval]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna
Identifiers
NCT: NCT07546136 · DUAL