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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: recFSH, HCG injection, Clomiphene Citrate 50 mg.
- Who it may be relevant to
- Registry conditions: Male Infertility. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hungary
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- 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
Primary outcome measures
- sperm DNA fragmentation [Time frame: 12 weeks of treatment]
- ejaculate volume [Time frame: 12 weeks of treatment]
- sperm concentration [Time frame: 12 weeks]
- sperm motility [Time frame: 12 weeks]
- total sperm count, total functional sperm count [Time frame: 12 weeks]
- Sperm morphology [Time frame: 12 weeks]
Secondary outcome measures (4)
- gonadotropin vs clomiphene - total sperm count, total functional sperm count [Time frame: 12 weeks of treatment]
- gonadotropin vs clomiphene - DNA fragmentation [Time frame: 12 weeks]
- Gonadotropin vs clomiphene - sperm total motility, progressive motility [Time frame: 12 weeks]
- gonadotropin vs clomiphene - normal sperm morphology [Time frame: 12 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Hungary · 1 center
- Reproductive Medicine Centre, Department of Obstetrics and Gynecology, University of Szege — Szeged
Identifiers
NCT: NCT07523022 · NNGYK943