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临床试验/NCT04210765
NCT04210765已完成4 期

The Effect of Incremental Clomiphene Citrate(CC) Doses in Successive Induction Cycles on the Endogenous Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH) and Steroid Hormone Responses to Treatment

Bagcilar Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年8月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Changes in the endogenous blood levels of FSH, LH in successive cycles

研究概览

简要总结

This study was planned to assess the initial and endogenous FSH, LH and steroid responses to incremental CC doses in successive ovulation induction cycles to treat anovulation in patients with unexplained infertility.

详细描述

In the Bagcilar Research and Training Hospital Obstetrics and Gynecology department outpatient clinic for infertility, the basal gonadotropin and androgen levels are routinely measured. In unexplained infertility couples with normal ovarian reserves the first line drug used for ovulation induction is CC. The starting dose is 50mg/day and the treatment is started within the 2nd to the 5th days of the menstrual cycle and continued for 5 days. Starting on the 2nd-3rd day following the last dose of the drug, the follicular growth was monitored with the transvaginal ultrasound and blood levels of hormones including FSH, LH, estradiol, progesterone, androstenedione, testosterone, and dehydroepiandrosterone sulphate were measured every 2-3 days. In this follow-up, if no follicular growth was observed day21 of the cycle, the CC dose was increased to CC 100mg/day (2X1, 50mg). If follicular growth and ovulation is achieved with no concluding conception, the same dose of CC is used in the following 2-3 cycles. When a maximum number of 2 dominant follicles are obtained ovulation is triggered with recombinant human chorionic gonadotropin (rhCG) and timed coit or intrauterine insemination is conducted.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Investigator)

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 20-35 years of age
  • unexplained infertility
  • first-line treatment
  • Normal or increased ovarian reserve
  • lack of ovulatory response to CC 50mg for 5 days

排除标准

  • Male factor
  • Tubal Factor
  • Severe endometriosis
  • Previous ovarian surgery

研究组 & 干预措施

Clomiphene citrate group 1

Active Comparator

Clomiphene citrate dose 50mg/day for 5 days starting on cycle day (2-4).

干预措施: Clomiphene Citrate (Drug)

Clomiphene citrate group 2

Active Comparator

Non-responsive to ovulation induction with Clomiphene Citrate with dose:50mg/day; and treated with dose:100mg/day in the succeeding cycle for 5 days, starting on cycle day (2-4).

干预措施: Clomiphene Citrate (Drug)

结局指标

主要结局

Changes in the endogenous blood levels of FSH, LH in successive cycles

时间窗: Menstrual cycle at day 3 and day 9 and the trigger day respectively (each cycle is 28 days

FSH (mIU/ml), LH (mIU/ml) blood levels measured with Enzyme-Linked ImmunoSorbent Assay (ELISA) tests.

Changes in the endogenous blood levels of steroids (including Androstenedione, Progesterone, Testosterone, estradiol) in successive cycles

时间窗: Menstrual cycle at day 3 and day 9 and the trigger day respectively (each cycle is 28 days)

Blood levels of steroids: Androstenedione (ng/ml), Progesterone (ng/ml), Testosterone (ng/ml), estradiol (pg/ml) measured with ELISA tests.

次要结局

  • conception rate(15-20 days following intrauterine insemination.)

研究者

发起方
Bagcilar Training and Research Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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