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Clinical Trials/ACTRN12623000329662
ACTRN12623000329662
Recruiting
Phase 3

Impact of clomiphene on semen parameters in normogonadotrophic idiopathic male infertility: a double-blind randomised placebo-controlled trial

Hudson Institute of Medical Research0 sites32 target enrollmentMarch 29, 2023

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.

Registry
who.int
Start Date
March 29, 2023
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
Male

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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