None listed
Conditions
Brief summary
The purpose of this study is to evaluate whether clomiphene improves sperm quantity and quality in men with unexplained infertility and low sperm counts. Eligible men recruited from fertility clinics will be randomised to either clomiphene or placebo for 6 months. Both clomiphene and placebo will be taken as a once daily oral capsule. Both groups of men will also receive a men’s fertility multivitamin (Menevit). We hypothesise that clomiphene will increase sperm production compared to placebo.
Interventions
Prospective double-blind randomised control trial comparing clomiphene versus placebo in men with unexplained infertility and normal levels of serum gonadotrophins.
Eligible men will be randomised to one of two study groups in a 1:1 ratio (clomiphene or placebo). Both groups will receive menevit, which is a commercially available men's fertility multivitamin.
Intervention group
- Clomiphene 25 mg once daily, oral tablet, duration 6 months (180 days)
- Menevit 1 tablet daily, oral tablet, durat
Prospective double-blind randomised control trial comparing clomiphene versus placebo in men with unexplained infertility and normal levels of serum gonadotrophins. Eligible men will be randomised to one of two study groups in a 1:1 ratio (clomiphene or placebo). Both groups will receive menevit, which is a commercially available men's fertility multivitamin. Intervention group - Clomiphene 25 mg once daily, oral tablet, duration 6 months (180 days) - Menevit 1 tablet daily, oral tablet, duration 6 months (180 days) Adherence will be assessed by research team by inspecting a medication diary kept by participants.
Sponsors
Hudson Institute of Medical Research
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1) Men of heterosexual couples with at least 12 months of infertility 2) Aged 18-50 years at enrolment 3) Able to provide informed consent in English 4) Have at least two semen analysis in the preceding 6 months showing oligozoospermia (<10 million/ml or total count <26 million)
Exclusion criteria
Azoospermia BMI >= 35 kg/m2 Serum FSH >8.4 IU/L Morning serum total testosterone <8 nmol/L Serum oestradiol >160 pmol/L Any genetic or endocrine disorder known to cause infertility (e.g. Prader-Willi, hyperprolactinaemia, Yq deletion, hypogonadotrophic hypogonadism). Any medications within the prior 6 months known to disrupt the hypothalamic-pituitary gonadal axis, e.g. testosterone, aromatase inhibitors, opioids. History of testicular cancer or surgery, untreated cryptorchidism, previous chemotherapy, or pelvic irradiation, large or clinically significant varicocele, prior vasectomy. Current genitourinary tract infection or seminal white cell count >1 mill/ml Sperm antibodies >50% bound (excluding tail-tip only) Retrograde ejaculation Systemic severe chronic disease (e.g. severe kidney or liver disease) Current smoker Alcohol abuse >20 standard drinks per week
Outcome results
None listed