Ovulation Induction With GnRH Analogue or Dual Trigger?

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.

Study Overview

• Status: Recruiting
• Conditions: Fertility Preservation; Oncological Disease

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Giulia Borghese, MD; Phone Number: +393289477743; Email: giulia.borghese@aosp.bo.it

Study Locations

• Italy
  • Bologna
    • Bologna, Bologna, Italy, 40138
      • Recruiting
      • IRCCS Azienda Ospedaliero-Universitaria di Bologna
      • Contact: Giulia Borghese, MD; Phone Number: +393289477743; Email: giulia.borghese@aosp.bo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with oncological disease attending the UO Gynecology and Human Reproduction Pathophysiology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di S. Orsola, for fertility preservation through oocyte cryopreservation.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of oocytes retrieved	Oocyte retrieval count	During oocyte retrieval procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oocyte retrieval rate	Number of oocytes retrieved / number of aspirated follicles	2 hours after oocyte retrieval
Number of mature oocytes (number of metaphase II oocytes)	Count of retrieved metaphase II oocytes	2 hours after oocyte retrieval
Patients who develop OHSS	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	Within 7 days after oocyte retrieval
Correlation between E2 levels and number of oocytes retrieved	Count of oocytes retrieved	2 hours after oocyte retrieval

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2025
• Primary Completion (Estimated): March 6, 2027
• Study Completion (Estimated): April 3, 2027

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: April 20, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: DUAL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No