A Randomised Controlled trial investigating the effects of Progesterone for luteal phase support in Natural Cycles for unexplained infertility - Progesterone in Natural Cycles (PiNC)

Homerton University Hospital NHS Trust0 个研究点目标入组 200 人开始时间: 2019年10月3日最近更新: 2024年9月9日

适应症

试验速览

暂无简介。

•bilateral patent tubes within last 12 months (HSG/HyCoSy/Laparoscopy)
•Ovulation as defined by regular cycles or ultrasound appearance of either a corpus luteum or dominant follicle or midluteal progesterone over 30nmol/ml
•Regular intercourse and failure to conceive for at least 12 months
•Willingness to participate, disclose personal data and provide written consent
•Semen analysis with:
•>15 mil/ml concentration
•Motility over 40%
•Progressive motility over 32%
•= 4% normal forms
•No erectile dysfunction or other problem preventing penetrative intercourse
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 200
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•Age =42 years
•Unilateral tubal patency
•Abnormal uterine cavity as seen on ultrasound
•History of Myocardial infarction, cerebrovascular disorders, arterial or venous thromboembolism, thrombophlebitis or retinal thrombosis.
•Undiagnosed vaginal bleeding
•Known or suspected progesterone sensitive malignant tumours
•Severe hepatic dysfunction or disease
•Known missed abortion or ectopic pregnancy or missed miscarriage (if these are diagnosed during the trial any Cyclogest being used will be discontinued by the clinical team)
•Hypersensitivity to the active substance or vegetable fat.
•Diabetes Mellitus

发起方

Homerton University Hospital NHS Trust