A Prospective Randomized Trial to Study the Effect of Luteal Progesterone Support on Pregnancy Rates in Combined Clomiphene Citrate and Gonadotropin Ovulation Induction Protocol With Intrauterine Insemination.
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 520
- 试验地点
- 1
- 主要终点
- Effect on Pregnancy rate measured by detectable embryonic cardiac activity
研究概览
简要总结
To determine the difference in clinical pregnancy rates with and without luteal progesterone support in a young reproductive aged population having undergone ovulation induction with combined clomiphene citrate and gonadotropin protocol with intrauterine insemination.
详细描述
To determine the difference in clinical pregnancy rates with and without luteal progesterone support in a young reproductive aged population having undergone ovulation induction with combined clomiphene citrate and gonadotropin protocol with intrauterine insemination.
Patients will be randomized in a treatment arm or control arm. The treatment arm receives the luteal progesterone support and the control arm does not. Each arm will have 260 patients.
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
- None
入排标准
- 年龄范围
- 18 Years 至 37 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18-37
- •BMI 19-34 kg/m2
- •Day 2-3 Follicle stimulating hormone (FSH) less than 10IU/mL
- •Estradiol (E2) less than 80 pg/mL
- •Anti-mullerian hormone (AMH) more than 1.5 ng/mL; or antral follicle count (AFC) up to 10
- •Two patent fallopian tubes confirmed by hysterosalpingogram (HSG) or chromopertubation
- •Normal uterine cavity confirmed by HSG, saline sonohysterogram (SIS) or hysteroscopy
排除标准
- •Severe male factor (total count less than 10 million sperm)
- •Systemic diseases not limited to diabetes
- •Pregnancy within 3 months
- •More than 1 prior cycle of gonadotropin treatment
- •Any ovarian cyst >15mm that has persisted for > 1 month
- •Endometrioma and/or Endometriosis-stage III or IV
- •Submucosal uterine fibroids; untreated endometrial polyps >1 cm;abnormal reproductive tract bleeding
- •Intolerance or allergy to study drug
- •Substance abuse (including alcohol and tobacco)
- •History of chemotherapy (except for gestational conditions) or radiotherapy
- •Minors and those adults not capable of consenting on their own
研究组 & 干预措施
Control
This arm receives Menopur 150 international units x 1 dose
干预措施: Menopur 150 international units (Drug)
Treatment
This arm receives Menopur 150 international units x 1 dose and Endometrin 100mg twice a day x 14 days
干预措施: Menopur 150 international units (Drug)
Treatment
This arm receives Menopur 150 international units x 1 dose and Endometrin 100mg twice a day x 14 days
干预措施: Endometrin 100 mg (Drug)
结局指标
主要结局
Effect on Pregnancy rate measured by detectable embryonic cardiac activity
时间窗: 10 months
次要结局
未报告次要终点