LUMO Study: Luteal Phase Support in IUI MOH Treatment Luteal Phase Support in IUI MOH
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- UMC Utrecht
- 入组人数
- 1,008
- 试验地点
- 1
- 主要终点
- Live Birth
研究概览
简要总结
The LUMO study is a multicenter, randomized controlled trial that evaluates the effectivity of luteal phase support in MOH/IUI treatment.
详细描述
Participating sites consist of academic and non-academic hospitals and fertility clinics in The Netherlands. There are two treatment arms (MOH/IUI treatment with LPS vs MOH/IUI treatment with placebo) with a non-blinded superiority design. Participants are randomly distributed across both treatment arms for the entire study-period (six months, non-crossover).
Eligibility criteria are: 1) couples starting IUI with Mild Ovarian HyperStimulation (MOH), with the intend to receive this treatment for at least six months. 2) Indication for MOH/IUI treatment is in accordance with current (dutch) NVOG guidelines; Diagnosis of unexplained (primary or secondary) infertility with Hunault <30% (or >30%, after an expectant management period of at least 6 additional months). Total mobile sperm count (VCM) >10 million. 3) Females aged >18 years with regular menstrual cycle.
(Mild) Ovarian stimulating treatment and insemination are according to regular treatment protocol. Females assigned to the treatment group start LPS, applying 3dd200mg Utrogestan in vaginal capsules, on the day of IUI. Treatment is continued until the onset of menstruation, a negative pregnancy test, miscarriage or confirmed vital intra-uterine pregnancy at 7 weeks gestation.
Main outcome is pregnancy within 6 months of treatment, leading to Live birth. Secondary outcomes are; Clinical pregnancy rate. Miscarriage rate. Multiple pregnancy rate. Pregnancy complications. Perinatal outcomes. Side effects and compliance to therapy. Added Medication Costs. Budget impact.
The analyses will include a cost-effectiveness analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blinded superiority design
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Couples starting IUI with Mild Ovarian HyperStimulation (MOH), with the intend to receive this treatment for at least six months.
- •Diagnosis of unexplained (primary or secondary) infertility
- •Hunault <30% (or >30%, after an expectant management period of at least 6 additional months).
- •Females aged >18 years with regular menstrual cycle.
- •Total mobile sperm count (VCM) >10 million.
- •Exclusion cirteria:
- •Cycle irregularities
- •Male factor infertility
排除标准
- 未提供
研究组 & 干预措施
MOH/IUI treatment with placebo
Females will receive regular MOH/IUI treatment. The female cycle is mildly stimulated and monitored until the desired amount of ripe follicles is achieved. In the absence of other reasons to cancel the treatment, ovulation is triggered and subsequently pre-washed semen is inseminated into the uterus.
Females assigned to the placebo group start placebo, applying 3dd1 vaginal capsules, on the day of IUI. Treatment is continued until the onset of menstruation, a negative pregnancy test, miscarriage or confirmed vital intra-uterine pregnancy at 7 weeks gestation
干预措施: Placebo (Drug)
MOH/IUI treatment with LPS
(Mild) Ovarian stimulating treatment and insemination are according to regular treatment protocol. Females assigned to the treatment group start LPS, applying 3dd200mg Utrogestan in vaginal capsules, on the day of IUI. Treatment is continued until the onset of menstruation, a negative pregnancy test, miscarriage or confirmed vital intra-uterine pregnancy at 7 weeks gestation
干预措施: Progesterone Vaginal Product (Drug)
结局指标
主要结局
Live Birth
时间窗: 6 months
Pregnancy leading to Live birth within six months.
次要结局
- Budget impact(1 year)
- Clinical pregnancy rate(<6 months)
- Miscarriage rate(<6 months)
- Multiple pregnancy rate(<6 months)
- Pregnancy complications(1 year)
- Perinatal outcomes(<6 weeks)
- Side effects(<1 year)
- Compliance to therapy(6 months)
- Added medication costs(1 year)
研究者
Frank JM Broekmans
Professor in Reproductive Endocrinology & Surgery
UMC Utrecht