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临床试验/NCT07460674
NCT07460674尚未招募不适用

Serum FSH Levels During Controlled Ovarian Stimulation

McGill University Health Centre/Research Institute of the McGill University Health Centre1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2026年2月16日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
500
试验地点
1
主要终点
-Trigger day FSH levels

研究概览

简要总结

Follicle-stimulating hormone (FSH) plays a central role in controlled ovarian stimulation (COS) during in vitro fertilization (IVF) cycles. While baseline FSH is commonly used to assess ovarian reserve, the clinical significance of dynamic FSH changes during stimulation remains unclear. Limited evidence suggests that serum FSH levels during COS may reflect ovarian response and could be associated with follicular development and treatment outcomes, yet FSH is not routinely monitored throughout stimulation protocols.

This prospective single-center cohort study aims to evaluate the dynamics of serum FSH levels during COS and to examine their association with ovarian response and IVF outcomes. Serum FSH, luteinizing hormone (LH) and estradiol (E2) will be measured at predefined time points during stimulation. Associations between FSH levels and oocyte yield, embryo development, and pregnancy outcomes will be analyzed to better understand the clinical relevance of FSH monitoring during IVF treatment.

详细描述

Background and Rationale

Follicle-stimulating hormone (FSH), secreted by the anterior pituitary gland in response to gonadotropin-releasing hormone (GnRH), plays a critical role in ovarian follicular development and estradiol production. In assisted reproductive technologies (ART), exogenous FSH is administered during controlled ovarian stimulation (COS) to promote multifollicular growth. Although baseline FSH is widely used as a marker of ovarian reserve and predictor of ovarian response, the clinical significance of dynamic FSH changes during stimulation remains insufficiently characterized.

Day 7 of stimulation represents a clinically important time point during which follicular growth and synchronization are assessed. Prior studies have suggested that serum FSH levels during COS may correlate with ovarian response and may reflect an individualized FSH threshold beyond which increasing exogenous dosing may not improve follicular recruitment. However, consensus is lacking regarding the clinical utility of serial FSH monitoring during stimulation, and it is not routinely incorporated into IVF protocols.

Understanding the relationship between FSH dynamics, follicular development, estradiol production, and treatment outcomes may support more individualized stimulation strategies and improve reproductive outcomes.

Study Design

研究设计

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

入排标准

年龄范围
18 Years 至 44 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients undergoing controlled ovarian stimulation
  • All stimulation protocols (agonist and antagonist).
  • All gonadotropin formulation (Gonal-F, Menopur, Rekovelle, Puregon).

排除标准

  • Cancer fertility preservation patients .
  • Patients over age 44.

研究组 & 干预措施

Stimulation patients

Patients undergoing controlled ovarian stimulation at the MUHC Reproductive Center.

结局指标

主要结局

-Trigger day FSH levels

时间窗: 60 months

Serum Follicle-stimulating hormone (FSH) (mIU/mL) measured at the day of the trigger shot

Trigger day E2 levels

时间窗: 60 months

Serum Estradiol (E2) (pg/mL) levels measured at trigger shot day

Number of patients reaching trigger

时间窗: 60 months

The number of patients that received the trigger shot and proceeding to oocyte retrieval / The number pf patients canceled during the ovarian stimulation

Number of oocytes retrieved

时间窗: 60 months

The number of oocytes collected in the oocyte retrieval procedure

Number of transferable embryos

时间窗: 60 months

Number of embryos were transferred in the fresh cycle plus the number of frozen embryos

次要结局

  • Biochemical pregnancy rate(60 months)
  • Clinical pregnancy rate(60 months)
  • Miscarriage rate(60 months)

研究者

发起方
McGill University Health Centre/Research Institute of the McGill University Health Centre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Dahan

Assistant Professor, Department of Obstetrics & Gynecology

McGill University Health Centre/Research Institute of the McGill University Health Centre

研究点 (1)

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