The impact of scrotal cooling on semen quality for male-factor infertility.

Not Applicable

• Conditions: asthenoteratozoospermia; oligozoospermia; teratozoospermia; asthenozoospermia; idiopathic male-infertility; Reproductive Health and Childbirth - Fertility including in vitro fertilisation

• Registration Number: ACTRN12624000550505
• Lead Sponsor: ational Health and Medical Reserach Council

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-01
• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

1)Men presenting to the fertility clinic or donors with reduced semen quality based on one or more of the following parameters:
i.Total sperm number per ejaculate of > 1 million but < 39 million.
ii.Progressive motility less than or equal to 31%.
iii.Normal forms <4%.
2)At least 6 months of regular (2 times/week) sexual intercourse without success.
3)A partner aged 35 years or less and with regular menstrual cycles and no known cause of infertility.
4)Men aged between 18 to 60 years old.
5)Men able to give 6 donations over the trial period.
6)Both male and female partner able to provide signed, written informed consent.
7)Both male and female partner prepared to have unprotected, non-contraceptive sexual intercourse every 2-3 days with the intention to initiate a pregnancy for the duration of the trial.
8)A female partner who is willing to consent to or provide the results of a hCG blood test or ultrasound for pregnancy confirmation.

Exclusion Criteria

1)Either partner has a known genetic disorder or chromosomal abnormalities.
2)Either partner with a past history of chemotherapy/radiotherapy that could affect fertility, or men with post-pubertal mumps, orchitis or orchidectomy of any cause.
3)Men who have presented or been treated for orchitis, epididymitis or urethritis in the past year.
4)Any form of smoking (tobacco, marijuana etc) within the past year (self report).
5)Either partner with a past or current history of a relevant infectious disease (chlamydia, gonorrhoea, genital herpes, hepatitis B, HIV/AIDS or syphilis).
6)Either partner with a chronic medical condition, including: Cancer, Chronic Obstructive Pulmonary Disease, Crohns disease, cystic fibrosis, diabetes, epilepsy, heart disease, multiple sclerosis, or Parkinson’s disease.
7)Either partner with a serious psychiatric condition including autism, attention deficit-hyperactivity disorder, bipolar disorder, major depressive disorder and schizophrenia that may prevent compliance with the protocol.
8)Couples that intend on using Assisted concpetion in the next 8 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the total amount of sperm produced[Microscope to count sperm/mL to obtain concentration, then multiply this by semen volume collected baseline samples, 4-week samples post-baseline, 8-week samples post-baseline, 4-week samples post-completion, 8-week samples post-completion. <br>];Sperm morphology[Krugers criteria baseline samples, 4-week samples post-baseline, 8-week samples post-baseline, 4-week samples post-completion, 8-week samples post-completion. ];sperm motility[Computer assisted semen analysis baseline samples, 4-week samples post-baseline, 8-week samples post-baseline, 4-week samples post-completion, 8-week samples post-completion. ]

Secondary Outcome Measures

Name	Time	Method
Sperm DNA damage[r terminal deoxynucleotidyl transferase biotin-dUTP nick end labeling (TUNEL) and HaloSperm test. baseline samples, 4-week samples post-baseline, 8-week samples post-baseline, 4-week samples post-completion, 8-week samples post-completion. ];Pregnancy rates[Self-report with peripheral blood sample Human chorionic gonadotropin test. Pregnancy within the year with treatment]