ACTRN12623000329662
Recruiting
Phase 3
Impact of clomiphene on semen parameters in normogonadotrophic idiopathic male infertility: a double-blind randomised placebo-controlled trial
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Male infertility
- Sponsor
- Hudson Institute of Medical Research
- Enrollment
- 32
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Not specified
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