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ENROLLING BY INVITATION
NCT07523022
PHASE4

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

Sponsor: Szeged University

View on ClinicalTrials.gov

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.

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2024-09-01

Completion Date

2026-12-01

Last Updated

2026-04-16

Healthy Volunteers

No

Interventions

DRUG

recFSH

recFSH 3x150NE sc weekly for 12 weeks

DRUG

HCG injection

hCG 2x5000NE sc weekly for 12 weeks

DRUG

Clomiphene Citrate 50 mg

clompihene-citrate 50mg p.o. daily for 12 weeks

Locations (1)

Reproductive Medicine Centre, Department of Obstetrics and Gynecology, University of Szeged

Szeged, Hungary