Predicting Ovarian Response in Artificial Insemination With Low Stimulation
试验速览
- 阶段
- 不适用
- 发起方
- Isala
- 入组人数
- 510
- 试验地点
- 7
- 主要终点
- To assess the relationship between AMH serum levels and ovarian response
研究概览
简要总结
This large prospective multi-center cohort study aims to identify patient's characteristics that significantly influence ovarian response to mild stimulation with a fixed dose of 75 IU recombinant FSH.
详细描述
A multi-center, open-label, prospective cohorts study. Patients with a regular indication for COH/IUI (controlled ovarian stimulation/ intra uterine insemination) will be asked to participate. Patient's characteristics will be documented including age, weight, BMI, smoking status, cycle day 2 3 or 4 FSH /Estradiol levels, antral follicle count, and AMH. AMH and FSH/Estradiol will be determined centrally after completion of inclusion of all patients in the study. All patients will receive a fixed 75 IU recFSH per day conform normal stimulation protocol starting from cycle day 3, 4 or 5 after exclusion of ovarian cysts by ultrasound. Ovarian response will be documented by ultrasound only. Once the dominant follicle(s) reach a mean diameter of 16-18 mm, hCG (5000IU or 250 mcg) will be applied and insemination will be scheduled 36-42 hours later. Cancellation criteria will be defined according to the national guidelines provided by the NVOG (7).
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •couples with unexplained or mild male subfertility (1-3) and a spontaneous chance of conception below 40% (Hunault score).
- •Unexplained subfertility including minimal to mild endometriosis (AFS grade 1 or 2) is defined as the failure to conceive after at least one year of unprotected intercourse whereas the standard fertility work-up was unable to detect any factors that might influence fertility negatively.
- •semen analysis should be normal according to the WHO guidelines (8),
- •ovulation should be documented (by BBT charts, ovulation detection by ultrasound or normal luteal progesterone values),
- •tubal patency should be confirmed (HSG, laparoscopy or fertiloscopy) and when a postcoital test was performed a cervical factor should have been excluded.
- •Mild male subfertility is defined as abnormal semen parameters according to the WHO (8) but an average total motile sperm account before processing of at least 10 million.
排除标准
- •Hunault score ≥ 40%
- •Endometriosis AFS grade 3 or 4
- •Contra-indications for the use of gonadotrophins (cysts larger than 2 cm, allergy for gonadotrophins)
- •Total motile sperm count after sperm processing below 1 million
- •Women aged younger than eighteen years or older than 45 years.
- •Previous treatment with COH/IUI for treating current subfertility
- •Unable to speak or read the Dutch language
研究组 & 干预措施
Subfertile couples
Subfertile couples presenting at fertility clinics with an indication for IUI in stimulated cycles
All patients will receive a fixed 75 IU recombinant follicle stimulating hormone per day conform normal stimulation protocol starting from cycle day 3, 4 or 5. Once the dominant follicle(s) reach a mean diameter of 16-18 mm, hCG (5000IU or 250 mcg) will be applied and insemination will be scheduled 36-42 hours later. Patients will be followed for the time of one menstrual cycle.
干预措施: Follicle Stimulating Hormone (Drug)
结局指标
主要结局
To assess the relationship between AMH serum levels and ovarian response
时间窗: one menstrual cycle, one month
(defined by the number of dominant follicles \>15mm) in IUI cycles stimulated with a fixed dose of 75 IU recFSH. All follicles \> 11 mm will be documented
次要结局
- Pregnancy rate per started cycle.(three months)
- Cancellation rate per stimulated cycle(one menstrual cycle, one month)
- To assess the relationship between age, weight, BMI, smoking, AFC, FSH/E2 on CD3 and ovarian response(one menstrual cycle, one month)
- Multiple pregnancy rate per started cycle.(three months)
- Miscarriage rate per started cycle.(five months)