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 sites200 target enrollmentOctober 3, 2019

Overview

No summary available.

Registry

who.int

Start Date

October 3, 2019

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

Homerton University Hospital NHS Trust

•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

•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