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临床试验/NCT02377479
NCT02377479撤回不适用

Endocrinology Profile in Patients Undergoing Clomiphene, Letrozole, and Combination Clomiphene and Letrozole Cycles

University Hospitals Cleveland Medical Center1 个研究点 分布在 1 个国家开始时间: 2015年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
The endocrinology profile (LH, FSH, estradiol, inhibin B) during a letrozole, clomiphene, and combination letrozole and clomiphene cycle

研究概览

简要总结

The goal of the study is to measure serial hormonal levels in patients undergoing clomiphene, letrozole, and a combination clomiphene and letrozole cycle. This information may help us to optimize less expensive medications for ovulation induction, reduce the number of treatment cycles to achieve a successful pregnancy, and use a medication regimen that may result in fewer multiple gestation pregnancies.

详细描述

After the initial physician consultation and investigations have been completed, the treatment options will be reviewed with the patient. If the patient chooses ovulation induction with an oral medication, then she will be offered participation in the study.

If she chooses to participate, the patient will then undergo ovulation induction with either clomiphene, letrozole, or a combination of both medications. The patient will be randomized to the order that each medication regimen will be started. Prior to starting each treatment cycle, a serum beta-hCG (serum beta-hCG < 5IU/L) or urine pregnancy test will be performed to rule out pregnancy.

During one treatment cycle, the patient will take 100mg clomiphene orally from cycle days 3-7. This dose is routinely used for ovulation induction in the investigators clinic. Blood work including an estradiol (E2), FSH, inhibin B and LH will be obtained on cycle days 3, 7, and 9. As these lab tests are routinely performed in the investigators REI laboratory, there will be no additional cost to the patient. A baseline follicle count by ultrasound during each treatment cycle will be measured on cycle day 3, and then again on cycle day 12, 13, or 14, depending on the cycle length until the lead follicle is 18mm or greater. Once at least one follicle has reached this mature size, an Ovidrel trigger (250 mcg hCG subcutaneously) will be administered to initiate ovulation. The patient will have an intrauterine insemination (IUI) 36 hours after Ovidrel injection. These procedures are the current standard of care in the investigators fertility center for patients with unexplained infertility.

Ovulation during each treatment cycle will also be confirmed with a serum progesterone measurement >3 nmol/L on cycle day 20-25. This blood test is not always performed, but is a common way to assess ovulation.

If the patient ovulated, a pregnancy test will be performed approximately 2 weeks later. If pregnancy has not occurred, the next medication would be attempted after the patient has a period.

研究设计

研究类型
Interventional
分配方式
Randomized
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 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 18-40 years old
  • Body mass index (BMI) > 18 kg/m^2 and < 40kg/m^2
  • No contraindications to clomiphene or letrozole
  • Ovulatory women
  • 1 month without any fertility medication

排除标准

  • Patients unable to consent for the study
  • Patients with polycystic ovarian syndrome or anovulatory women

研究组 & 干预措施

Clomiphene alone

Active Comparator

The patient will take 100mg clomiphene orally from cycle days 3-7

干预措施: Clomiphene (Drug)

Letrozole alone

Active Comparator

The patient will take 5mg Letrozole orally from cycle days 3-7

干预措施: Letrozole (Drug)

Combination Clomiphene and Letrozole

Experimental

The patient will take a dose of 5mg Letrozole every night and 100mg clomiphene every day after lunch from cycle days 3-7.

干预措施: Clomiphene (Drug)

Combination Clomiphene and Letrozole

Experimental

The patient will take a dose of 5mg Letrozole every night and 100mg clomiphene every day after lunch from cycle days 3-7.

干预措施: Letrozole (Drug)

结局指标

主要结局

The endocrinology profile (LH, FSH, estradiol, inhibin B) during a letrozole, clomiphene, and combination letrozole and clomiphene cycle

时间窗: 1 month

The LH, FSH, estradiol, inhibin B levels will be measured on cycle days 3, 7, and 9.

次要结局

  • 1. Pregnancy rate(1 month)
  • Ovulation rate(1 month)
  • Number of mature follicles (>/= 18mm)(1 month)
  • Ongoing pregnancy rate (pregnancy with fetal heartbeat > 12 weeks gestational age)(12 weeks)
  • Miscarriage rate(10 weeks)
  • Multiple pregnancy rate (twins and higher order multiples)(6- 8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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