drugset / Trial / NCT07523022

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

NCT07523022

Phase 4 Enrolling by invitation 500 enrolled Szeged University
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2024-09-01
Primary completion
2026-09-01
Completion
2026-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Clomiphene Other / unclassified 50 mg Oral
Subject Follitropin beta Protein / enzyme biologic 150 iu Subcutaneous
Subject hCG Unknown 5000 iu Subcutaneous

Indications