Male infertility Urological and Genital Diseases
Conditions
Interventions
Patients will be randomised using the Sealed envelope platform on the computer to receive either 25mg Clomifene Citrate or a matching placebo, to be taken orally once a day for 9 months.
• Experimenta
Sponsors
University College London Comprehensive Clinical Trials Unit
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Men assigned as biological male at birth 2. Aged =18-<45 years inclusive at baseline and randomisation. 3. Diagnosis of primary or secondary infertility at the time of screening, having been trying to conceive for =12 months with abnormal semen parameters due to: (i) reduced sperm concentration of =16 million spermatozoa per ml on as per the WHO criteria, or (ii) secondary functional hypogonadism (defined as early rise total testosterone =12pmol/l) after excluding other causes 4. Capacity to give informed consent
Exclusion criteria
Exclusion criteria: 1. Primary testicular failure (confirmed with an FSH level of =15 IU/L) at time of screening 2. History of primary or secondary hypogonadotropic hypogonadism due to other congenital or acquired condition disturbing the hypothalamic-pituitary gonadal axis. 3. History of taking prescribed or non-prescribed hormonal treatment therapy including but not limited to clomifene, gonadotrophins, anabolic steroids and exogenous testosterone. 4. Other causes of male infertility including but not limited to; known obstructive azoospermia, untreated clinical varicocele, history of mumps orchitis, history of chemotherapy/radiotherapy treatment. 5. Abnormal karyotype, evidence of Y chromosome AZF microdeletion, cystic fibrosis gene abnormality, history of cryptorchidism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sperm concentration measured using semen analysis (millions per millilitre (millions/mL) at the 6-month visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of pregnancy outcome (spontaneous or with ART) including miscarriage, stillbirth, livebirth and neonatal death measured using data collection from patient records at the 18-month visit;Time to the first incidence of pregnancy from randomisation measured using data collection from patient records at the 18-month visit;Incidence of the need to undergo Surgical Sperm Retrieval (SSR) procedure, the type and the outcome of the SSR procedure measured using data collection from patient records at the 18-month visit;Biochemical outcomes: LH, FSH, Oestradiol, early rise total and free testosterone, oestradiol: testosterone ratio, sex hormone-binding globulin, prolactin, kidney and liver function profile measured using standard medical laboratory methods at the 3-, 6- and 9-month visits;Clinical outcome: BMI (kg/m2) measured using standard methods at the 3-, 6- and 9-month visits;Quality of Life outcomes measured using the Male Sexual Health Questionnaire (MSHQ) and the EQ-5D-5L questionnaire at the 3-, 6-, 9- and 18-month visits;Adverse Events and Reactions (AEs/ARs) at all grades and Serious Adverse Events and Reactions (SAEs/SARs) at all grades measured using data from Case Report Forms (CRFs) at any time throughout the duration of the trial;Sperm concentration measured using semen analysis at 3-, and 9-month visits;Total sperm count as per WHO criteria measured using semen analysis at 3-, 6- and 9-month visits;Percent of total sperm motility as per WHO criteria measured using semen analysis at 3-, 6- and 9-month visits;Percent of progressive sperm motility as per WHO criteria measured using semen analysis at 3-, 6- and 9-month visits;Percent of normal sperm morphology as per WHO criteria measured using semen analysis at 3-, 6- and 9-month visits;Incidence of spontaneous clinical pregnancy measured using data collection from patient records at the 18-month visit;Incidence of the need to use any Assisted Reproductive Technology (ART) treatments measured using data | — |
Countries
England, United Kingdom
Contacts
Public ContactRumana Jalil
Outcome results
None listed