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NCT Number: NCT07546136

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.

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Key information

Age range

18 year–46 year

Sex eligibility

Female

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location status: Recruiting

Location contact

Giulia Borghese, MD

CONTACT

[email protected]

+393289477743

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of oocytes retrieved

    Time frame: During oocyte retrieval procedure

    Oocyte retrieval count

Secondary outcomes

  1. Oocyte retrieval rate

    Time frame: 2 hours after oocyte retrieval

    Number of oocytes retrieved / number of aspirated follicles

  2. Number of mature oocytes (number of metaphase II oocytes)

    Time frame: 2 hours after oocyte retrieval

    Count of retrieved metaphase II oocytes

  3. Patients who develop OHSS

    Time frame: 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

  4. Correlation between E2 levels and number of oocytes retrieved

    Time frame: 2 hours after oocyte retrieval

    Count of oocytes retrieved

Study contacts

Contact information is provided by the study sponsor or research team.

Giulia Borghese, MD

CONTACT

[email protected]

+393289477743

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 22, 2026
Registry last updated
Apr 22, 2026

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.

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