Clomiphene in male infertility (CIMI) trial: A double-blind randomised placebo-controlled trial of clomiphene in normogonadotrophic idiopathic male infertility

Phase 3

Recruiting

• Conditions: Male infertility; Reproductive Health and Childbirth - Fertility including in vitro fertilisation

• Registration Number: ACTRN12623000329662
• Lead Sponsor: Hudson Institute of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-29
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 32

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total sperm count, measured on a standard semen analysis.[ 4 weeks after commencement of intervention<br>12 weeks after commencement of intervention<br>24 weeks after commencement of intervention (primary timepoint) ]