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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APHRODITE category 2 treated with gonadotropin | Experimental | subcutaneous recFSH 3x150NE weekly for 12 weeks |
|
| APHRODITE category 2 treated with clomiphene-citrate | Experimental | per os 50mg clomiphene-citrate daily for 12 weeks |
|
| APHRODITE category 3 treated with gonadotropin | Experimental | subcutaneous recFSH 3x150NE weekly and subcutaneous hCG 2x5000NE weekly for 12 weeks |
|
| APHRODITE category 3 treated with clomiphene-citrate | Experimental | per os 50mg clomiphene-citrate daily for 12 weeks |
|
| APHRODITE category 4 treated with gonadotropin | Experimental | subcutaneous hCG 2x5000NE weekly for 12 weeks, if FSH level drops below 1.5 IU/l, subcutaneous recFSH 3x150NE weekly added |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| recFSH | Drug | recFSH 3x150NE sc weekly for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks of treatment |
| ejaculate volume | ejaculate volume (ml) after treatment are assessed and compared to the pretreatment values. Higher number means improvement in this outcome. | 12 weeks of treatment |
| sperm concentration | Sperm concentrations (million/ml) before and after the treatment are compared. Higher number means improvement in this outcome. | 12 weeks |
| sperm motility | Sperm total motility (%), progressive motility (%) after the treatment are compared to the pretreatment values. Higher numbers mean improvement in this outcome. | 12 weeks |
| 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. | 12 weeks |
| 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 12 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Gonadotropin hormones | serum FSH (IU/l), LH (IU/l) are measured after the treatment and compared to the pretreatment values. | 12 weeks of treatment |
| Testosterone level | Total testosterone (nmol/l) is measured after the treatment and compared to the pretreatment values. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Norbert Pásztor, MD, PhD | University of Szeged, Department of Obstetrics and Gynecology, Reproductive Medicine Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reproductive Medicine Centre, Department of Obstetrics and Gynecology, University of Szeged | Szeged | 6724 | Hungary |
IPD used in the results publication, especially general information (age, BMI, smoking habits, alcohol consumption of patients), sperm analysis results, hormonal results.
Starting after publication
Researchers upon request by email (hirt78@gmail.com)
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The sperm analysis after the treatment is performed by a biologist, who is masked about the type of the treatment
|
| HCG injection | Drug | hCG 2x5000NE sc weekly for 12 weeks |
|
|
| Clomiphene Citrate 50 mg | Drug | clompihene-citrate 50mg p.o. daily for 12 weeks |
|
|
| 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 (%) |
| 12 weeks |
| 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 (%) | 12 weeks |
| 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 (%) | 12 weeks |
| 12 weeks |
| Estradiol level | Estradiol (pmol/l) are measured after the treatment and compared to the pretreatment results | 12 weeks |
| ID | Term |
|---|---|
| D007248 | Infertility, Male |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007246 | Infertility |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D006063 | Chorionic Gonadotropin |
| D002996 | Clomiphene |
| ID | Term |
|---|---|
| D006062 | Gonadotropins |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010926 | Placental Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011257 | Pregnancy Proteins |
| D011506 | Proteins |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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