Observation of the Response to Ovulation Induction on the Day of Intrauterine Insemination and Correlation Between Progesterone Level and Pregnancy Rate (OVUL-IIU)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- Rate of early pregnancies based on progesterone levels measured on the day of ovulation trigger
研究概览
简要总结
Intrauterine inseminations (IUI) are a commonly used technique in assisted reproductive technology (ART) to help women conceive, whether within a couple or as single individuals. However, national success rates remain modest, with an average live birth rate of 10% per cycle, which leads many ART centers to favor in vitro fertilization (IVF) as a more effective option.
Nevertheless, IUI retains several advantages: it is less invasive, less expensive, and, when appropriately indicated, can achieve satisfactory outcomes.
Guidelines exist for ovarian stimulation protocols prior to IUI, aimed at optimizing the chances of success. So far, no clear superiority has been demonstrated between pharmacological ovulation triggering and spontaneous ovulation. However, accurate timing of insemination in relation to ovulation is recognized as a key factor for success.
Very few studies have focused on the response to ovulation triggering, and none have explored a correlation with clinical pregnancy rates.
Yet, monitoring of the luteal phase and response to ovulation triggering is a common practice in ART, particularly in the context of frozen embryo transfers (FET), suggesting that these parameters may be worth further investigation in the context of IUI.
Hence, the interest of this study is to determine whether there is a correlation between progesterone levels and clinical pregnancy rates in patients undergoing intrauterine insemination (IUI).
详细描述
This is a single-center observational cohort study with retrospective and prospective data collection.
Participation in the study is offered in the CHIC MPA department. Data will be collected over a 12-month period.
The research consists of retrieving data from the patient's and spouse's medical records and from software for presenting biological laboratory results .
Patients and their spouses will be informed of the study orally, and will receive a written information note.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Single women or couples, heterosexual or homosexual, undergoing insemination at the medically assisted procreation.center
- •Aged 18 to 43
- •Any indication for IUI in compliance with the Recommendations for Good Practices in MPA (RBP)
- •Blood test on the day of insemination with estradiol, progesterone, LH and hCG measured as part of routine care
排除标准
- •Opposition of patients to data collection
结局指标
主要结局
Rate of early pregnancies based on progesterone levels measured on the day of ovulation trigger
时间窗: 6-7 weeks Gestational Age
Rate of early pregnancies based on progesterone levels measured on the day of ovulation trigger
次要结局
- Predictive factor for pregnancy: age (years)(From enrollment until the morning of insemination (between 1 and 4 hours before insemination))
- Rate of early pregnancies (HCG > 100) and ultrasound (6-7 weeks gestational age)(6-7 weeks Gestational Age)
- Rate of spontaneous miscarriage(From enrollment until 12 weeks Gestational Age)
- Estradiol level the morning of the insemination (pg/ml)(The morning of the insemination (between 1 and 4 hours before the insemination))
- LH level the morning of the insemination (UI/L)(The morning of the insemination (between 1 and 4 hours before the insemination))
- hCG level the morning of the insemination (UI/L)(The morning of the insemination (between 1 and 4 hours before the insemination))
- Progesterone level the morning of the insemination (ng/ml)(The morning of the insemination (between 1 and 4 hours before the insemination))
- Time between first IUI and early pregnancy (HCG > 100 (UI/L)(From first IUI until HCG > 100 (UI/L))
- Predictive factor for pregnancy: BMI ( kg/m^2)(From enrollment until the morning of insemination (between 1 and 4 hours before insemination))
- Predictive factor for pregnancy:number of inseminated spermatozoa (millions)(From enrollment until the morning of insemination (between 1 and 4 hours before insemination))