Clomiphene in male infertility (CIMI) trial: A double-blind randomised placebo-controlled trial of clomiphene in normogonadotrophic idiopathic male infertility
Impact of clomiphene on semen parameters in normogonadotrophic idiopathic male infertility: a double-blind randomised placebo-controlled trial
Hudson Institute of Medical Research
32 participants
Nov 25, 2024
Interventional
Conditions
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.
Eligibility
Inclusion Criteria4
- Men of heterosexual couples with at least 12 months of infertility
- Aged 18-50 years at enrolment
- Able to provide informed consent in English
- Have at least two semen analysis in the preceding 6 months showing oligozoospermia (<10 million/ml or total count <26 million)
Exclusion Criteria14
- 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
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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, duration 6 months (180 days) Adherence will be assessed by research team by inspecting a medication diary kept by participants.
Locations(2)
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ACTRN12623000329662