By InvitationPhase 4

Comparison of the Effect of Gonadotropin and Clomiphene Citrate Treatment on Sperm Parameters and the Outcome of Assisted Reproductive Procedures in Subfertile Men Based on the APHRODITE Groups

Hungary500 participantsStarted 2024-09-01

Plain-language summary

Men enrolled in the study are assigned to each APHRODITE group. Group 2,3,4 are treated with either gonadotropin preparations or clompihene-citrate (except group 4). The type of the treatment (gonadotropin vs clomiphene) is randomized. After treatment, hormonal measurements, spermiogram and DNA fragmentation tests are repeated, allowing for analysis of the outcome.

Who can participate

Age range18 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * abnormal sperm analysis result, APHRODITE 2,3,4 categories Exclusion Criteria: * obstructive azoospermia * non-obstructive azoospermia due to genetical defects (Klinefelter-syndrome, AZFa, AZFb microdeletion syndrome etc) * problems with the administration of subcutaneous injections * disagreement

What they're measuring

sperm DNA fragmentation

Timeframe: 12 weeks of treatment

ejaculate volume

Timeframe: 12 weeks of treatment

sperm concentration

Timeframe: 12 weeks

sperm motility

Timeframe: 12 weeks

total sperm count, total functional sperm count

Timeframe: 12 weeks

Sperm morphology

Timeframe: 12 weeks

Trial details

NCT IDNCT07523022

SponsorSzeged University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-01

View on ClinicalTrials.gov More Male Infertility trials