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临床试验/NCT01286051
NCT01286051已完成不适用

Efficacy of Single Dose Ganirelix in Gonadotropin Ovulation Induction Cycles

Houston Fertility Institute1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2011年1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
已完成
发起方
入组人数
80
试验地点
1
主要终点
Pregnancy rates

研究概览

简要总结

Ovulation induction (OI) using gonadotropins is one of the most widely prescribed treatments of infertility. One common problem encountered while attempting OI using gonadotropins is premature ovulation. The purpose of this study is to examine the effect of a single injection of a medication, called ganirelix, to prevent premature ovulation. Patients will be divided into two groups. In the first group, gonadotropins will be used to stimulate the ovaries. In the second group gonadotropins will be used in addition to a single injection of ganirelix, a gonadotropin releasing hormone (GnRH) antagonist. Pregnancy rates will be compared between groups.

详细描述

A randomized prospective study will be performed on patients attempting pregnancy using ovulation induction/intra-uterine insemination (IUI). Patients will be randomly assigned to one of two protocols:

Protocol A (control group): On menstrual cycle day 3, the patient will start gonadotropins (Follistim) injections at a starting dose of 75-150 IU and monitored according to the discretion of the treating physician. When the leading follicle reaches a size of at least 18mm, intramuscular human chorionic gonadotripin (hCG) (10,000 IU) is administered, followed by two inseminations, one at 12 hours after hCG, and the other at 36 hours. All patients will have luteal support using progesterone vaginal suppositories at a dose of 200mg two times per day (BID). Pregnancy testing will be scheduled at 2 weeks after the IUI. The treatment cycle typically lasts from 8-13 days, depending on the patient's response.

Protocol B (study group): On menstrual cycle day 3, the patient will start gonadotropins (Follistim) injections at a starting dose of 75-150 IU and monitored according to the discretion of the treating physician. When the leading follicle reaches a size of 13-14mm in mean diameter, or when the estradiol level reaches a level of 400 pg/ml, ganirelix injection at the standard dose of 250mcg is given once subcutaneously. When the leading follicle reaches a size of at least 18mm, intramuscular hCG (10,000IU) is administered followed by two inseminations, one at 12 hours after hCG, and the other at 36 hours. All patients will have luteal support using progesterone suppositories at a dose of 200mg BID. Pregnancy testing will be scheduled at 2 weeks after the IUI. The treatment cycle typically lasts from 8-13 days, depending on the patient's response.

Patients will be randomized, via computer generated program, in a 1:1 fashion.

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 39 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients undergoing ovulation induction (OI) between ages 18 - 39 years.
  • One or more of the following infertility diagnoses: ovulation dysfunction, mild male factor infertility (sperm concentration of 5- 20 million/ml, and/or sperm motility 10% - 40%) , absence teratospermia (i.e. strict morphology > 4%), unexplained infertility.
  • Patent Fallopian tubes.
  • Normal uterine structure (i.e. absence of mullerian anomalies)
  • Ability to consent to the study.
  • Patients should be Houston Fertility Institute patients

排除标准

  • Exclusion criteria include:
  • Age 39 or above
  • Severe male factor (concentration < 10 million/ml or strict morphology < 4%)
  • Obstructed Fallopian tubes on one or both sides
  • Stage III or IV endometriosis
  • Elevated FSH level (>10 IU/L)
  • Low antral follicular count (< 4 antral follicles per ovary)
  • Any other contraindication for ovulation induction
  • Inability to consent to the study
  • History of any prior failed OI/IUI cycle

研究组 & 干预措施

Follistim

Active Comparator

standard treatment

干预措施: Follistim administration (Drug)

Follistim plus single ganirelix injection

Experimental

干预措施: Follistim plus Ganirelix (Drug)

结局指标

主要结局

Pregnancy rates

时间窗: One cycle of controlled ovarian stimulation (one month)

Follicle stimulating hormone (FSH) and IUI

次要结局

  • Premature leuteinizing hormone (LH) surge and ovulation(One cycle of controlled ovarian stimulation (one month))

研究者

发起方
Houston Fertility Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ghassan F. Haddad

Medical Director

Houston Fertility Institute

研究点 (1)

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