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临床试验/NCT01941875
NCT01941875已完成3 期

The Effect of Luteal Phase Support on Pregnancy Rate in Intrauterine Insemination Cycles Following Ovarian Stimulation With Gonadotropins

University of Alberta1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2014年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
300
试验地点
1
主要终点
Clinical pregnancy rate

研究概览

简要总结

This is a study of patients undergoing Controlled Ovarian Hyperstimulation (COH) with Gonadotropins and Intrauterine Insemination (IUI) at a Fertility Clinic.

Infertility is a common problem, and a popular method of therapy is to inject sperm through the cervix and into the uterus, a procedure known as IUI. In conjunction with IUI, injectable medications (gonadotropins) are used to stimulate the ovaries to produce more than one egg per cycle in a process called COH.

Vaginal progesterone is used for luteal support in in vitro fertilization therapy and has been proven to effect pregnancy rates. However, the role of progesterone in COH is still unclear. In this study, the investigators want to examine the effect of giving vaginal progesterone after COH with IUI on pregnancy rates. The investigators want to study if luteal vaginal progesterone results in a higher pregnancy rate compared to no progesterone therapy in COH with IUI. At present, fertility centres vary in the use of progesterone after insemination, most likely due to the lack of studies on this subject.

At the Fertility Clinic all patients undergoing COH with injectable medications and IUI, regardless of whether they are in the study, have a baseline transvaginal ultrasound and blood tests. Patients start the injectable medications for COH until the ovarian follicles are large enough, then a medication to release the eggs is given. The IUI is done approximately 36 hours later. The day after the IUI, study patients will be given vaginal progesterone while the control patients will receive no progesterone. All patients will be followed until a pregnancy test is done and a viable foetus is confirmed by ultrasound.

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
21 Years 至 43 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Couples with infertility
  • Confirmed bilateral tubal patency
  • More than 10 million motile sperm available for IUI

排除标准

  • Subjects declining enrollment
  • Allergies to prescribed vaginal progesterone
  • Subjects less than 21 years old or over 43 years old

研究组 & 干预措施

Luteal Vaginal Progesterone

Experimental

Experiment group: Vaginal progesterone for luteal support beginning the first day after IUI

干预措施: Progesterone Effervescent Vaginal Tablets (Drug)

结局指标

主要结局

Clinical pregnancy rate

时间窗: After 6 weeks gestational age

Presence of a fetal heart beat after 6 weeks gestational age

次要结局

  • Multiple Pregnancy(After 6 weeks gestational age)
  • Non-viable Pregnancy(After 6 weeks gestational age)
  • Biochemical Pregnancy(After 6 weeks gestational age)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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