A study investigating whether progesterone supplementation in otherwise unmedicated, natural menstrual cycles can improve live birth rates

Phase 1

Active, not recruiting

Conditions: nexplained infertility
MedDRA version: 20.1Level: PTClassification code 10049513Term: Luteal phase deficiencySystem Organ Class: 10014698 - Endocrine disorders
Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

Registration Number: EUCTR2019-003468-27-GB

Lead Sponsor: Homerton University Hospital NHS Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 200

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

•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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): Biochemical pregnancy rates (positive urine HCG test at least 14 days after starting progesterone)<br>Clinical pregnancy (intrauterine gestational sac confirmed on ultrasound at 6-8 weeks gestation)<br>Mid-luteal serum progesterone levels <br><br>Clinical efficacy outcomes/clinical safety outcomes:<br><br>Miscarriage and ectopic pregnancy rates<br>Stillbirth (pregnancy loss after 24 weeks of gestation)<br>;Timepoint(s) of evaluation of this end point: End of trial