MedTrace Logo

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 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2026-04-16

No results posted yet for this study

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.

Conditions

  • Male Infertility

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

Sponsors & Collaborators

  • Szeged University

    lead OTHER

Principal Investigators

  • Norbert Pásztor, MD, PhD · University of Szeged, Department of Obstetrics and Gynecology, Reproductive Medicine Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Hungary

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07523022 on ClinicalTrials.gov