Male Infertility
Conditions
Keywords
APHRODITE classification, male infertility, gonadotropin therapy, clomiphene-citrate
Brief 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
Interventions
DRUGrecFSH
recFSH 3x150NE sc weekly for 12 weeks
DRUGHCG injection
hCG 2x5000NE sc weekly for 12 weeks
clompihene-citrate 50mg p.o. daily for 12 weeks
Sponsors
Szeged University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Masking description
The sperm analysis after the treatment is performed by a biologist, who is masked about the type of the treatment
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| sperm DNA fragmentation | 12 weeks of treatment | sperm DNA fragmentation Index (%), high DNA stainability (%) are measured and compared to the pretreatment values. Lower numbers mean improvement in this outcome. |
| ejaculate volume | 12 weeks of treatment | ejaculate volume (ml) after treatment are assessed and compared to the pretreatment values. Higher number means improvement in this outcome. |
| sperm concentration | 12 weeks | Sperm concentrations (million/ml) before and after the treatment are compared. Higher number means improvement in this outcome. |
| sperm motility | 12 weeks | 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 | 12 weeks | 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 | 12 weeks | Percent of normal sperm morphology (%) is counted after the treatment and compared to the pretreatment result. Higher number mean improvement in this outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| gonadotropin vs clomiphene - total sperm count, total functional sperm count | 12 weeks of treatment | 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 | 12 weeks | 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 | 12 weeks | 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 | 12 weeks | 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 (%) |
Countries
Hungary
Contacts
PRINCIPAL_INVESTIGATORNorbert Pásztor, MD, PhD
University of Szeged, Department of Obstetrics and Gynecology, Reproductive Medicine Centre
Outcome results
None listed