Diagnosis and Treatment of Male Infertility Related to Inflammatory Syndrome: Therapeutic Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The number of live motile spermatozoa six month after the treatment
研究概览
简要总结
BACKGROUND: One couple out of 6 consults for infertility during their sexual life. In 60% of cases a male factor is associated or is the main infertility factor. Inflammatory Syndrome (IS), characterized by the presence of a leukocytospermia is found in 12% of the cases. Leukocyte degranulation causes oxidative stress (OS) through the formation of free radicals attacking the sperm cell functions.
HYPOTHESIS: To establish the responsibility of the IS, and OS, in chronicle inflammatory male infertility, the investigators hypothesize that its treatment (as well as its possible cause) must restore or improve the fertilizing capacity of patients sperm.
METHODS: This prospective randomized study will test the response to the treatment. The investigators shall measure cellular degradation products due to the OS, thereby certifying that it does have a deleterious effect on sperm cell. Seminal biochemistry will also assess the impact of the syndrome on the genital tract glands and follow its evolution.
The patients will be included in the study as soon as the leukocytospermia will be > 0,5*106/ml or as soon as the elastase will be > 500 ng/mL.
The examinations will be performed using flow cytometry, CASA (Computer Assisted Semen Analysis). The analysis of sperm morphology will be centralized.
Primary endpoint will be a reduction in the percentage of 8OH-dG below 35 %. We anticipate that it should arrive to 20 % of the patients included in the arm treatment by corticosteroid therapy. All in all will thus be needed 50 patients in the group placebo and 50 in the group treated.
Secondary endpoint the improvement of the spermatic parameters and the reduction of the fragmentation of the DNA of sperm cells to the treated subjects.
All these biological markers will be evaluated 6 month after the treatment:
- Fragmentation of the spermatic DNA below 37 % during the follow-up in 6 months
- Leukocytospermia and elastase
- Seminal biochemistry
- Other markers of the inflammatory syndrome and oxidative stress (protein carbonyl, 8OHd-Guanosine)
- Possibly the radiological examinations (Ultrasound and MRI of the genital tract)
In addition it would allow us to propose a policy of prevention towards acquired post-infectious male infertility.
详细描述
Progress of research. Timeframe Search
- Duration of inclusions: 30 months
- Duration of patient follow-up: 7 months
- Total duration of the study: 37 months Within the framework of their coverage in AMP, the barren couples have a consultation with the doctors of the reproduction and one with the biologists. Between these two visits, a spermatic balance assessment (EXAMINATION N°0) is made including a semen culture, a spermogram or a test of migration survival (TMS) and an elastase.
On the occasion of this examination, aliquots for the measure of 8OH-dG, fragmentation of the spermatic DNA and seminal biochemistry will systematically be taken.
Within the framework of this standard balance assessment of infertility, it is possible that an echography and a MRI of the genital ways are prescribed; if it is the case, the data of these examinations will be collected in the case report form. But these examinations will not be specifically asked for the search.
If a leukocytospermia ≥ 0,5*106/ml is discovered or an increase of the elastase ≥ 500 ng / ml, the dosages of 8OH-dG, the fragmentation and the seminal biochemistry will be made.
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
- Double (Participant, Investigator)
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
- •Man over 18 years old
- •Patient presenting a leukocytospermia ≥ 0,5*106 /ml or an elastase ≥ 500ng/ml
- •No infection
- •Signed informed consent
排除标准
- •Patient having less of 106 /ml of sperm cells in the ejaculate
- •Patients with diabetes or receiving treatment for diabetes
- •Patients already taking anti-inflammatory drugs
- •Patients with ongoing anticoagulant therapy
- •Patients with history of allergy to anti-inflammatory drug
- •Patients with a history of peptic ulcers
- •Patient with history of cardiovascular disease (hypertension, cardiac arrhythmia, ...)
- •Patients with psychological disorders
- •Patient with an infectious condition except for specified indications of Prednisone
- •Patients with some evolutional viruses(including hepatitis, herpes, chickenpox, shingles)
- •Patient is in a psychotic state still not controlled by treatment
- •Patient receiving a live vaccine
- •Patients with hypersensitivity to any component of Prednisone
- •Patient not affiliated with a social security system
- •Criteria for randomization
- •- Patient meeting all inclusion criteria and none of exclusion, and having a 8OH desoxy Guanosine increased ≥ 35%.
研究组 & 干预措施
Placebo
Placebo
干预措施: Placebo (Drug)
Treatment
Cortancyl (prednisone) 0,2 mg/kg/day for 3 weeks and 0,1mg/kg/day for 1 week
干预措施: Prednisone (Drug)
结局指标
主要结局
The number of live motile spermatozoa six month after the treatment
时间窗: 6 months
Reduction of the percentage of the spermatic 8OH-dG under 35 % to 20 % of the patients between the visit of inclusion / randomization and the visit of follow-up in 6 months
次要结局
- biological markers(6 months)