Effect of Personalized Dosages of Rekovelle on the Number of Mature Follicles Reached in Intra-uterine Insemination
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Ovarian response
研究概览
简要总结
This study is intended for women undergoing their first cycle of 3 intrauterine inseminations. All 3 inseminations will be personalized by using algorithms to determine the dose of study medication.
详细描述
Study medication dosage for the first insemination cycle will be based on the woman's age as well as her Anti-Mullerian Hormone (AMH) levels.
Study medication dosage for the second and third insemination will depend on ovarian response (number of follicles) during previous insemination cycle and woman's age
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women having consented to the study
- •Women followed at fertility center
- •First IUI cycle
- •Women between the ages of 18 to 42 inclusively at time of consent form signature
- •AMH < 35 pmol/L (4.9 ng/mL) in participants' file in the last 24 months
- •At least one permeable Fallopian tube confirmed by laparoscopy, hysterosalpingography (HSG), hysterosalpingosonography (HSSG) or one pregnancy in the last 3 years
- •Insemination with either partner or donor sperm
- •Male partner semen analysis considered adequate for IUI in accordance to the centre's standard practice
- •Menstrual cycles from 26 to 39 days
- •Presence of both ovaries
排除标准
- •Unable to consent
- •Body weight >100 kg
- •AMH ≥35 pmol/L (4.9 ng/mL) in participants' file in the last 24 months
- •Severe malformation (unicornuate or bicornuate uterus) or uterine anomaly including fibroids ≥ 5 cm
- •Uncontrolled thyroid or adrenal dysfunction
- •Pituitary tumour
- •Persistent ovarian cysts or enlargement not due to PCOS (Polycystic ovary syndrome) > 3 cm
- •Anovulatory women
- •Use of contraceptives in the last 3 months prior to start of stimulation
- •Diagnosis of hydrosalpinx
- •Malignancies
- •Breast pathology incompatible with gonadotropin stimulation
- •Hypersensitivity to follitropin delta or to any ingredient in the formulation
- •Addition of other infertility medication that can influence follicle stimulation and maturation such as growth hormone (GH)
研究组 & 干预措施
Rekovelle (Follitropin delta)
All participants will receive a prescription for study medication Rekovelle (follitropin delta)
干预措施: Follitropin delta (Drug)
结局指标
主要结局
Ovarian response
时间窗: 1 year
Evaluate the dose-response Relationship of Rekovelle with respect to ovarian response in participants undergoing controlled ovarian stimulation for intrauterine insemination
次要结局
- Pregnancy rate(1 year)