Unexplained infertility MedDRA version: 20.1 Level: PT Classification code 10049513 Term: Luteal phase deficiency System Organ Class: 10014698 - Endocrine disorders
Conditions
Interventions
Trade Name: Cyclogest
Product Name: Cyclogest
Pharmaceutical Form: Pessary
INN or Proposed INN: Progesterone
CAS Number: 57-83-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentra
Sponsors
Homerton University Hospital NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Female: • 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 Male: • 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
Exclusion criteria
Exclusion criteria: Exclusion criteria: • Age =42 years • Unilateral tubal patency • BMI =30 • 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 • Porphyria • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Does progesterone supplementation in otherwise un-medicated, natural menstrual cycles for women with unexplained infertility improve their chances of having a live birth?;Secondary Objective: Does treatment with extra progesterone hormone in otherwise natural menstrual cycles for women with unexplained infertility increase their progesterone levels and/or improve their chances of conceiving a pregnancy?;Primary end point(s): Live Birth Rate;Timepoint(s) of evaluation of this end point: End of trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Biochemical pregnancy rates (positive urine HCG test at least 14 days after starting progesterone) Clinical pregnancy (intrauterine gestational sac confirmed on ultrasound at 6-8 weeks gestation) Mid-luteal serum progesterone levels Clinical efficacy outcomes/clinical safety outcomes: Miscarriage and ectopic pregnancy rates Stillbirth (pregnancy loss after 24 weeks of gestation) ;Timepoint(s) of evaluation of this end point: End of trial | — |
Countries
United Kingdom
Contacts
Public ContactDr Claudia Raperport
Homerton University Hospital
Outcome results
None listed