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
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- sperm DNA fragmentation
研究概览
简要总结
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.
详细描述
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:
- information, examination
- classification into the APHRODITE category based on the results
- randomization (gonadotropin or clomiphene citrate)
- injection treatment for patients in the gonadotropin group, with therapy according to the APHRODITE category for 12 weeks
- tablet treatment for patients in the clomiphene citrate group for 12 weeks
- control spermiogram and DNA fragmentation
- analysis of the results of subsequent assisted reproduction procedures
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
盲法说明
The sperm analysis after the treatment is performed by a biologist, who is masked about the type of the treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •abnormal sperm analysis result, APHRODITE 2,3,4 categories
排除标准
- •obstructive azoospermia
- •non-obstructive azoospermia due to genetical defects (Klinefelter-syndrome, AZFa, AZFb microdeletion syndrome etc)
- •problems with the administration of subcutaneous injections
- •disagreement
研究组 & 干预措施
APHRODITE category 2 treated with gonadotropin
subcutaneous recFSH 3x150NE weekly for 12 weeks
干预措施: recFSH (Drug)
APHRODITE category 2 treated with clomiphene-citrate
per os 50mg clomiphene-citrate daily for 12 weeks
干预措施: Clomiphene Citrate 50 mg (Drug)
APHRODITE category 3 treated with gonadotropin
subcutaneous recFSH 3x150NE weekly and subcutaneous hCG 2x5000NE weekly for 12 weeks
干预措施: recFSH (Drug)
APHRODITE category 3 treated with gonadotropin
subcutaneous recFSH 3x150NE weekly and subcutaneous hCG 2x5000NE weekly for 12 weeks
干预措施: HCG injection (Drug)
APHRODITE category 4 treated with gonadotropin
subcutaneous hCG 2x5000NE weekly for 12 weeks, if FSH level drops below 1.5 IU/l, subcutaneous recFSH 3x150NE weekly added
干预措施: HCG injection (Drug)
APHRODITE category 3 treated with clomiphene-citrate
per os 50mg clomiphene-citrate daily for 12 weeks
干预措施: Clomiphene Citrate 50 mg (Drug)
APHRODITE category 4 treated with gonadotropin
subcutaneous hCG 2x5000NE weekly for 12 weeks, if FSH level drops below 1.5 IU/l, subcutaneous recFSH 3x150NE weekly added
干预措施: recFSH (Drug)
结局指标
主要结局
sperm DNA fragmentation
时间窗: 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
时间窗: 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
时间窗: 12 weeks
Sperm concentrations (million/ml) before and after the treatment are compared. Higher number means improvement in this outcome.
sperm motility
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- gonadotropin vs clomiphene - total sperm count, total functional sperm count(12 weeks of treatment)
- gonadotropin vs clomiphene - DNA fragmentation(12 weeks)
- Gonadotropin vs clomiphene - sperm total motility, progressive motility(12 weeks)
- gonadotropin vs clomiphene - normal sperm morphology(12 weeks)
研究者
Dr. Pásztor Norbert
associate professor
Szeged University