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Ovulation Trigger Strategies in Low Ovarian Reserve (TRIGGERBEST) (TRIGGERBEST)

Ovulation Trigger Strategies in Women With Low Ovarian Reserve Undergoing Fresh In Vitro Fertilization Cycles: A Prospective Randomized Controlled Trial (TRIGGERBEST)

This study aims to compare different ovulation triggering strategies in women with low ovarian reserve undergoing fresh in vitro fertilization (IVF) cycles.

Ovulation triggering is a key step in IVF treatment, as it determines final oocyte maturation prior to oocyte retrieval.

Participants are randomly assigned to one of three ovulation trigger approaches: human chorionic gonadotropin (hCG) alone, follitropin delta combined with hCG, or dual trigger using a gonadotropin-releasing hormone (GnRH) agonist plus hCG.

The primary objective is to evaluate wether adding follitropin delta at the time of triggering increases the number of matura oocytes obtained, without adversely affecting implantation rates. Pregnancy otucomes following fresh embryo transfer will also be assessed.

The results of this study may help optimize ovulation triggering strategies in women with low ovarian reserve undergoing IVF treatment.

研究概览

详细说明

Final oocyte maturation is a critical step in assisted reproductive techniques (ART) and is largely determined by the ovulation triggering strategy. In women with low ovarian reserve, achieving an adequate number of mature oocytes remains a major challenge, even when established trigger protocols are used.

Dual trigger strategies combining hCG and a GnRH agonist are widely used in this population, based on evidence suggesting improved oocyte maturation. However, despite this approach, oocyte yield and maturity often remain suboptimal. The addition of exogenous follicle-stimulating hormone (FSH) activity at the time of ovulation triggering has been proposed as a potential strategy to further optimize final oocyte maturation.

Follitropin delta has a distinct pharmacokinetic profile and provides individualized FSH exposure based on ovarian reserve markers. Its use in combination with hCG at the time of triggering may enhance oocyte maturation without compromising endometrial receptivity.

This prospective, randomized study compares three ovulation triggering strategies in women with low ovarian reserve undergoing fresh IVF cycles: hCG alone, follitropin delta combined with hCG, and dual triggering using a GnRH agonist plus hCG. Participants are randomly assigned to one of the three groups.

The primary outcome is the number of mature oocytes (metaphase II, MII) obtained at oocyte retrieval. Secondary outcomes include the proportion of mature oocytes, biochemical pregnancy rate per embryo transfer, and ongoing pregnancy rate following fresh embryo transfer.

The study aims to generate evidence to optimize ovulation triggering strategies in women with low ovarian reserve.

研究类型

介入性

注册 (估计的)

126

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

      • Valencia、西班牙、46010
        • 招聘中
        • Hospital Clínico Universitario de Valencia
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

Inclusion Criteria:

  • Signed informed consent.
  • Women aged between 18 and 42 years.
  • Primary infertility.
  • Women with low ovarian response classified within one of the groups defined by the POSEIDON criteria.

Exclusion Criteria:

  • More than two previous failed ovarian stimulation cycles.
  • Female age >42 years.
  • Body mass index (BMI) >35 kg/m².
  • Criteria of extremely low ovarian reserve according to the Spanish National Health System exclusion criteria (AMH <0.3 ng/mL and/or antral follicle count <5).
  • Male partner age >55 years.
  • Severe male factor infertility (total motile sperm count <1 million).
  • Previous voluntary sterilization (vasectomy or bilateral tubal ligation).
  • Previous healthy child shared by the couple.
  • Presence of medical conditions contraindicating pregnancy.
  • Risk of ovarian hyperstimulation syndrome (OHSS). If more than 15 follicles are expected on the day of trigger, the patient will be excluded from the study.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:hCG alone
Ovulation triggering using human chorionic gonadotropin (hCG) alone.
Human chorionic gonadotropin (hCG) administered for final oocyte maturation and ovulation triggering.
其他名称:
  • hCG
实验性的:Follitropin delta + hCG
Ovulation triggering using follitropin delta in combination with human chorionic gonadotropin (hCG).
Human chorionic gonadotropin (hCG) administered for final oocyte maturation and ovulation triggering.
其他名称:
  • hCG

Follitropin delta administered as part of the ovulation-triggering regimen for final oocyte maturation.

(hCG).

实验性的:Dual trigger
Ovulation triggering using a gonadotropin-releasing hormone (GnRH) agonist in combination with human chorionic gonadotropin (hCG).
Human chorionic gonadotropin (hCG) administered for final oocyte maturation and ovulation triggering.
其他名称:
  • hCG
Triptorelin, a gonadotropin-releasing hormone (GnRH) agonist, administered as part of the ovulation-triggering regimen for final oocyte maturation.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Number of mature oocytes (MII)
大体时间:During the oocyte retrieval procedure
Number of metaphase II (MII) oocytes obtained at oocyte retrieval following ovulation triggering
During the oocyte retrieval procedure

次要结果测量

结果测量
措施说明
大体时间
Proportion of mature oocytes
大体时间:During the oocyte retrieval procedure
Percentage of metaphase II (MII) oocytes relative to the total number of oocytes retrieved.
During the oocyte retrieval procedure
Biochemical pregnancy rate per embryo transfer
大体时间:10-14 days after embryo transfer
Positive beta-human chorionic gonadotropin (beta-hCG) test following fresh embryo transfer.
10-14 days after embryo transfer
Ongoing pregnancy rate
大体时间:6-7 weeks of gestation
Presence of a viable intrauterine pregnancy confirmed by ultrasound.
6-7 weeks of gestation

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Cesar Lizan Tudela、Department of Obstetrics and Gynaecology, Hospital Clínico Universitario de Valencia

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年9月17日

初级完成 (估计的)

2027年7月1日

研究完成 (估计的)

2028年1月1日

研究注册日期

首次提交

2026年3月21日

首先提交符合 QC 标准的

2026年9月9日

首次发布 (实际的)

2026年9月11日

研究记录更新

最后更新发布 (实际的)

2026年9月11日

上次提交的符合 QC 标准的更新

2026年9月9日

最后验证

2026年9月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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