2026-525747-33-00招募中4 期
Progesterone Luteal Support in Unexplained Infertility Management (PLUIM study)
Universitair Medisch Centrum Utrecht20 个研究点 分布在 1 个国家目标入组 640 人开始时间: 2026年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 640
- 试验地点
- 20
- 主要终点
- Pregnancy occurring within 6 months after randomisation, leading to a live birth.
研究概览
简要总结
To evaluate whether progesterone luteal phase support in women with unexplained infertillity during expectant management increases live birth rates, in comparison to no treatment (placebo arm).
研究设计
- 分配方式
- Randomized
- 主要目的
- Pluim Study
- 盲法
- Double (Carer, Subject, Investigator)
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 BMI <45 kg/m2
- •Female age ≥18 years old
- •assignment to expectant management during at least six months, in accordance with Dutch NVOG Guidelines
- •a Hunault prognostic score greater than or equal to 30%
- •primary or secondary infertility for at least a period of 1 year
- •regular menstrual cycle ranging between 21-35 days
- •total motile sperm count greater than or equal to 10 million/ml
- •no risk of tubal pathology (or in case of increased risk, tubal pathology excluded by tubal patency testing)
排除标准
- •Uncorrected uterine factors, such as endometrial polyps or submucosal fibroids
- •Insufficient knowledge or understanding of the Dutch or English language and not willing or able to receive study information via a certified translator
- •Not able or willing to provide (written) informed consent
- •Contraindications for vaginal progesterone, in particular: females with allergy to peanuts or soya
- •Formal diagnosis of endometriosis
结局指标
主要结局
Pregnancy occurring within 6 months after randomisation, leading to a live birth.
Pregnancy occurring within 6 months after randomisation, leading to a live birth.
次要结局
- Budget impact, Cost-effectiveness analyses using live birth rates and costs.
- Clinical pregnancy, ongoing pregnancy, biochemical pregnancy loss and miscarriage rates within 6 months after randomisation.
- Of all achieved (ongoing) pregnancies occurring within 6 months after randomisation the following outcomes are assessed; multiple pregnancy rate, time to pregnancy, pregnancy loss, pregnancy complications, perinatal outcomes, type of delivery and outcomes.
- Side effects and compliance to therapy assessed during treatment using a medication dairy and a questionnaire, send out 6 months after randomisation.
- Number of adverse events and serious adverse events
- Quality of life assessed at time of randomisation, and 6 and 18 months after randomisation, using the FertiQoL questionnaire.
- Progression to (MOH)IUI/IVF/ICSI within six months after randomisation.
- Use of ART and (ongoing) pregnancy achieved after the six-month study period and within 12 months follow up.
研究者
Simone
Scientific
Universitair Medisch Centrum Utrecht
研究点 (20)
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