Luteal Phase Support With Progesterone vs Estrogen and Progesterone on Pregnancy Rates in Ovarian Stimulation and Intrauterine Insemination Cycles: a Prospective Randomized Study
试验速览
- 阶段
- 4 期
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Clinical Pregnancy
研究概览
简要总结
This is a single center, 3 arms, prospective randomized controlled open study to determine the impact of luteal phase support on pregnancy rates in ovarian stimulation and IUI cycles with recombinant FSH in patients with unexplained infertility and mild male factor.
Patients will be randomized into 3 groups:
- Luteal support with progesterone only (they will received vaginal P gel (Crinone 8% vaginal gel; Serono, Israel)
- Luteal support with estrogen + progesterone [(Crinone 8% vaginal gel; Serono, Israel) and Estrofem 4mg].
- No luteal support
详细描述
Study design:
single center, 3 arms, prospective randomized controlled open study
Objective:
to determine the impact of luteal phase support on pregnancy rates in ovarian stimulation and IUI cycles with recombinant FSH in patients with unexplained infertility and mild male factor.
Methods:
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
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Couples with diagnosis of unexplained infertility
- •In their treatment cycle with ovarian stimulation and IUI using recombinant FSH in our institution.
排除标准
- •female partners with one or more of the following:
- •previous ovarian surgery
- •one ovary
- •polycystic ovaries on ultrasound examination
- •other endocrine abnormalities (i.e., polycystic ovarian syndrome, thyroid disorders,hyperprolactinemia,6.hypogonadotropic hypogonadism)
- •past ovarian hyperstimulation or hyperstimulation during the study period
- •diminished ovarian reserve (basal FSH level >15 IU/mL)
- •age of >40 years
- •sever male factor < 5 million total motile sperm on the day of insemination.
研究组 & 干预措施
Luteal support with progesterone only
Luteal support with progesterone only (they will received vaginal P gel (Crinone 8% vaginal gel; Serono, Israel)Luteal support will begin after insemination and will be continued through the 12th week of gestation if the patient conceived.
干预措施: Luteal support with progesterone only (Drug)
Luteal support with estrogen + progesterone
Luteal support with estrogen + progesterone [(Crinone 8% vaginal gel; Serono, Israel) and Estrofem 4mg].
干预措施: Luteal support with estrogen + progesterone (Drug)
No luteal support
干预措施: Insemination without luteal support (Procedure)
结局指标
主要结局
Clinical Pregnancy
时间窗: 4 weeks after insemintation
A pregnancy test will be performed 2 weeks after insemination (Serum hCG) an intrauterine pregnancy will be confirmed using a transvaginal ultrasound 2 weeks after a positive pregnancy test
次要结局
未报告次要终点