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临床试验/NCT07546136
NCT07546136招募中不适用

Ovulation Induction With GnRH Analogue or Dual Trigger?

IRCCS Azienda Ospedaliero-Universitaria di Bologna1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年4月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Number of oocytes retrieved

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 46 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • Hypersensitivity to one or more of the active substances used during the treatment

结局指标

主要结局

Number of oocytes retrieved

时间窗: During oocyte retrieval procedure

Oocyte retrieval count

次要结局

  • Oocyte retrieval rate(2 hours after oocyte retrieval)
  • Number of mature oocytes (number of metaphase II oocytes)(2 hours after oocyte retrieval)
  • Patients who develop OHSS(Within 7 days after oocyte retrieval)
  • Correlation between E2 levels and number of oocytes retrieved(2 hours after oocyte retrieval)

研究者

发起方
IRCCS Azienda Ospedaliero-Universitaria di Bologna
申办方类型
Other
责任方
Sponsor

研究点 (1)

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