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

INTERVENTION: 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 Concentration number: 400‐ CONDITION: Therapeutic area: Diseases [C] ‐ Female diseases of the urinary and reproductive systems and pregancy complications [C13] Unexplained infertility ; MedDRA version: 20.1 Level: PT Classification code 10049513 Term: Luteal phase deficiency System Organ Class: 10014698 ‐ Endocrine disorders PRIMARY OUTCOME: 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? Primary end point(s): Live Birth Rate 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? Timepoint(s) of evaluation of this end point: End of trial SECONDARY OUTCOME: 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 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