临床试验/2025-521234-28-00

2025-521234-28-00招募中3 期

Eight weeks of low dose hCG priming in women with diminished ovarian reserve undergoing IVF/ICSI – a randomized controlled trial

Rigshospitalet4 个研究点分布在 1 个国家目标入组 80 人开始时间: 2025年6月3日最近更新: 2025年6月3日

试验速览

阶段: 3 期
状态: 招募中
发起方: Rigshospitalet
入组人数: 80
试验地点: 4
主要终点: The number of oocytes retrieved after hCG vs placebo priming

研究概览入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The aim of the study is to examine the effects of low dose hCG priming for eight weeks in women with DOR undergoing IVF/ICSI. We want to retest the findings of our pilot study (Friis Wang et al. 2023), as an increase of 50% in number of oocytes retrieved is clinically relevant.

入排标准

年龄范围: 18 years 至 64 years（18-64 Years）
性别: Female
接受健康志愿者: 否

入选标准

•Female, Age 18-40 (both inclusive), Regular menstrual cycle (23-35 days), 1.-
•IVF/ICSI cycle at inclusion, AMH < 6.29 pmol/L (Elecsys® AMH assay)

排除标准

•Uterine malformations or hydrosalpinx, Submucosal uterine myomas, Uterine polyps, Allergy to standard IVF/ICSI medication, Endometriosis stage III-IV, Preimplantation genetic testing, Testicular sperm aspiration/extraction, Known severe comorbidity

结局指标

主要结局

The number of oocytes retrieved after hCG vs placebo priming

次要结局

Antral follicle count, AMH, number of follicles, number of fertilized eggs, number of cleaved day 2 embryos, number of good and top quality day 2 embryos, number of blastocysts, cycle cancellation rate, Reproductive hormone levels, granulosa cell receptor expression, prenancy and live birth rates

研究者

发起方

Rigshospitalet

申办方类型

Hospital/Clinic/Other health care facility

责任方

Principal Investigator

主要研究者

Kristine Løssl

Scientific

Rigshospitalet

研究点 (4)

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