AzTrials
AzTrials

Male InfertilityPhase 4GONACLONCT07523022

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

A Phase 4 study testing recFSH, HCG injection and Clomiphene Citrate 50 mg in people with Male Infertility, run by Szeged University at 1 site in Hungary.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Male Infertility
What is being tested?
recFSH, HCG injection and Clomiphene Citrate 50 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
1 siteHungary
Study dates
1 Sep 2024to 1 Dec 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • abnormal sperm analysis result, APHRODITE 2,3,4 categories

Who cannot join

  • obstructive azoospermia
  • non-obstructive azoospermia due to genetical defects (Klinefelter-syndrome, AZFa, AZFb microdeletion syndrome etc)
  • problems with the administration of subcutaneous injections
  • disagreement

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hungary1 site

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

    Szeged, 6724

Other trials in Hungary

About this study

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.

Read the detailed description

Our research involves male partners of couples suffering from male infertility. After a comprehensive andrological examination, based on the test results, the men are classified into so-called "APHRODITE" categories. Based on these categories, half of the patients are given so-called gonadotropin treatment (the exact treatment depends on the type of category), which involves subcutaneous injections several times a week for a total of 12 weeks. The other half of the patients are recommended oral tablets containing the active ingredient clomiphene citrate, also for 12 weeks. It is important that both types of therapy (gonadotropin and clomiphene citrate) are effective treatments in certain cases of male infertility, according to the literature, so all patients participating in the research receive effective treatment. However, it is decided who receives which treatment by randomization.

After the 12-week treatment, a control sperm analysis and a DNA fragmentation test are performed to determine the success of the treatment (changes in sperm analysis results and DNA fragmentation index).

The improvement in sperm parameters will be determined in the two treatment regimens, the rate of fertilized eggs in subsequent assisted reproduction cycles, the quality of the resulting embryos, and the rate of pregnancies and subsequent losses. The results of the two therapeutic modalities will be compared, so that it can be decided which treatment method is more effective.

The research process is essentially as follows:

  1. information, examination
  2. classification into the APHRODITE category based on the results
  3. randomization (gonadotropin or clomiphene citrate)
  4. injection treatment for patients in the gonadotropin group, with therapy according to the APHRODITE category for 12 weeks
  5. tablet treatment for patients in the clomiphene citrate group for 12 weeks
  6. control spermiogram and DNA fragmentation
  7. analysis of the results of subsequent assisted reproduction procedures
Being tested
recFSH, HCG injection, Clomiphene Citrate 50 mg
Keywords
APHRODITE classification, male infertility, gonadotropin therapy, clomiphene-citrate
Medical subject headings
Infertility, Male

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • recFSHDrug

    Also called recombinant FSH

    recFSH 3x150NE sc weekly for 12 weeks

  • HCG injectionDrug

    Also called human chorionic gonadotropin, choriogonadotropin alfa

    hCG 2x5000NE sc weekly for 12 weeks

  • Clomiphene Citrate 50 mgDrug

    Also called CC

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

Study groups in NCT07523022
Study groupRoleWhat they receive
APHRODITE category 2 treated with gonadotropinExperimentalsubcutaneous recFSH 3x150NE weekly for 12 weeks
Receives: Drug: recFSH
APHRODITE category 2 treated with clomiphene-citrateExperimentalper os 50mg clomiphene-citrate daily for 12 weeks
Receives: Drug: Clomiphene Citrate 50 mg
APHRODITE category 3 treated with gonadotropinExperimentalsubcutaneous recFSH 3x150NE weekly and subcutaneous hCG 2x5000NE weekly for 12 weeks
Receives: Drug: recFSH; Drug: HCG injection
APHRODITE category 3 treated with clomiphene-citrateExperimentalper os 50mg clomiphene-citrate daily for 12 weeks
Receives: Drug: Clomiphene Citrate 50 mg
APHRODITE category 4 treated with gonadotropinExperimentalsubcutaneous hCG 2x5000NE weekly for 12 weeks, if FSH level drops below 1.5 IU/l, subcutaneous recFSH 3x150NE weekly added
Receives: Drug: recFSH; Drug: HCG injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. sperm DNA fragmentation

    sperm DNA fragmentation Index (%), high DNA stainability (%) are measured and compared to the pretreatment values. Lower numbers mean improvement in this outcome.

    Measured: 12 weeks of treatment

  2. ejaculate volume

    ejaculate volume (ml) after treatment are assessed and compared to the pretreatment values. Higher number means improvement in this outcome.

    Measured: 12 weeks of treatment

  3. sperm concentration

    Sperm concentrations (million/ml) before and after the treatment are compared. Higher number means improvement in this outcome.

    Measured: 12 weeks

  4. sperm motility

    Sperm total motility (%), progressive motility (%) after the treatment are compared to the pretreatment values. Higher numbers mean improvement in this outcome.

    Measured: 12 weeks

  5. total sperm count, total functional sperm count

    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.

    Measured: 12 weeks

  6. Sperm morphology

    Percent of normal sperm morphology (%) is counted after the treatment and compared to the pretreatment result. Higher number mean improvement in this outcome.

    Measured: 12 weeks

Secondary outcomes (4)

  1. gonadotropin vs clomiphene - total sperm count, total functional sperm count

    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)

    Measured: 12 weeks of treatment

  2. gonadotropin vs clomiphene - DNA fragmentation

    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 (%)

    Measured: 12 weeks

  3. Gonadotropin vs clomiphene - sperm total motility, progressive motility

    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 (%)

    Measured: 12 weeks

  4. gonadotropin vs clomiphene - normal sperm morphology

    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 (%)

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2026
  2. Study start1 Sep 2024
  3. Primary completion1 Sep 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07523022
Sponsor's protocol ID
NNGYK943
Acronym
GONACLO
Status last verified
Apr 2026
First submitted
28 Mar 2026
Last updated
16 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD used in the results publication, especially general information (age, BMI, smoking habits, alcohol consumption of patients), sperm analysis results, hormonal results.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing recFSH, HCG injection and Clomiphene Citrate 50 mg in people with Male Infertility, run by Szeged University at 1 site in Hungary.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

sperm DNA fragmentation (time frame: 12 weeks of treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07523022.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.

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