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

Short name GONACLO

NCTNCT07523022Other idNNGYK943

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Enrolling by invitation
Phase: Phase 4
Enrollment: 500 participants (estimated)
Sponsor: Szeged University · Other
Design: Randomized · Single masking
Countries: 1 country
Hungary
Start: 1 Sept 2024
Primary completion: 1 Sept 2026 (estimated)
Completion: 1 Dec 2026 (estimated)
First posted: 13 Apr 2026
Last update posted: 16 Apr 2026
Conditions: Male Infertility

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2024202520262027

Ph 4
GONACLO
NCT07523022
1 Sept 2024 to est. 1 Dec 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

recFSHDrug
HCG injectionDrug
Clomiphene Citrate 50 mgDrug

Arms5

Experimental
APHRODITE category 2 treated with gonadotropin
subcutaneous recFSH 3x150NE weekly for 12 weeks
Experimental
APHRODITE category 2 treated with clomiphene-citrate
per os 50mg clomiphene-citrate daily for 12 weeks
Experimental
APHRODITE category 3 treated with gonadotropin
subcutaneous recFSH 3x150NE weekly and subcutaneous hCG 2x5000NE weekly for 12 weeks
Experimental
APHRODITE category 3 treated with clomiphene-citrate
per os 50mg clomiphene-citrate daily for 12 weeks
Experimental
APHRODITE category 4 treated with gonadotropin
subcutaneous hCG 2x5000NE weekly for 12 weeks, if FSH level drops below 1.5 IU/l, subcutaneous recFSH 3x150NE weekly added

Primary outcomes6

Outcomes the sponsor listed as primary.

sperm DNA fragmentation
Time frame · 12 weeks of treatment
Registry description
sperm DNA fragmentation Index (%), high DNA stainability (%) are measured and compared to the pretreatment values. Lower numbers mean improvement in this outcome.
ejaculate volume
Time frame · 12 weeks of treatment
Registry description
ejaculate volume (ml) after treatment are assessed and compared to the pretreatment values. Higher number means improvement in this outcome.
sperm concentration
Time frame · 12 weeks
Registry description
Sperm concentrations (million/ml) before and after the treatment are compared. Higher number means improvement in this outcome.
sperm motility
Time frame · 12 weeks
Registry description
Sperm total motility (%), progressive motility (%) after the treatment are compared to the pretreatment values. Higher numbers mean improvement in this outcome.
total sperm count, total functional sperm count
Time frame · 12 weeks
Registry description
Total sperm count (million) = ejaculate volume (ml) x sperm concentration (million/ml) and total functional sperm count (million) = total sperm count x progressive motility x 100 are compared before and after the treatment. Higher numbers mean improvement in this outcome.
Sperm morphology
Time frame · 12 weeks
Registry description
Percent of normal sperm morphology (%) is counted after the treatment and compared to the pretreatment result. Higher number mean improvement in this outcome.

Secondary outcomes(4)

gonadotropin vs clomiphene - total sperm count, total functional sperm count
Time frame · 12 weeks of treatment
Registry description
in the APHRODITE 2 and 3 groups, the results of the gonadotropin and clomiphene-citrate arms are compared regarding the percent of patients with improvement in total sperm count (million) and total functional sperm count (million)
gonadotropin vs clomiphene - DNA fragmentation
Time frame · 12 weeks
Registry description
in the APHRODITE 2 and 3 groups, the results of the gonadotropin and clomiphene-citrate arms are compared regarding the percent of patients with improvement in DNA fragmentation Index (%) and high DNA stainability (%)
Gonadotropin vs clomiphene - sperm total motility, progressive motility
Time frame · 12 weeks
Registry description
in the APHRODITE 2 and 3 groups, the results of the gonadotropin and clomiphene-citrate arms are compared regarding the percent of patients with improvement in total sperm motility (%) and progressive sperm motility (%)
gonadotropin vs clomiphene - normal sperm morphology
Time frame · 12 weeks
Registry description
in the APHRODITE 2 and 3 groups, the results of the gonadotropin and clomiphene-citrate arms are compared regarding the percent of patients with improvement in normal sperm morphology (%)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Male
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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