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

• Status: Enrolling By Invitation
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Szeged University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• Male Infertility

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-09-01
• Primary completion: 2026-09-01
• Completion: 2026-12-01
• First posted: 2026-04-13
• Last updated: 2026-04-16

Locations

1 site across 1 country: Hungary