Male Infertility and Complementary Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 主要终点
- Occurrence of pregnancy
研究概览
简要总结
The present Pocock clinical trial study was conducted In the city of Mashhad in Iran between 2015 and 2016. The study inclusion criteria were men with low fertility of sperm motility<25% and total motility <50% (asthenozoospermia), no history of endocrine diseases, no diabetes men, no hormonal problems in their wives, and a healthy salpingography in their wives. The study subjects were voluntarily assigned to royal gel and IUI groups. In royal gel group, 5 grams of royal gel was used after menstruation and every other night before and after intercourse. IUI group received 75 units of FSH from the second day of the cycle. Then vaginal ultrasound was performed from the sixth day of menstrual cycle to determine the right size of follicle. 10000 units of HCG was administered when follicle diameter reached 16mm, and the study subject was prepared for IUI 32-36 hours later. Each subject alternately swapped groups following fertility failure.
详细描述
After selection of subjects and obtaining their informed consents, the quality of royal gel was examined.
The quality of royal gel is determined by the amount of polyphenol it contains. Polyphenol in royal gel was assessed in the following stages: first, the sample was diluted with ethanol 50% to 1:10 ratio, and then, 100µl of this preparation was poured into a test tube, and 750µl of 1:10 diluted solution of FCR (Folin Ciocalteau Reagent) was added and left at room temperature for five minutes. Then, 750µl of sodium carbonate 6% solution was added to each tube, and after keeping these tubes in the dark for one hour, absorption was measured at 780nm wavelength. Negative control consisted of all reaction compounds, except the sample, for which, ethanol 50% was used instead. The sample concentration was determined using the gallic acid standard. By definition, the desirable quality of polyphenol in natural royal gel ranges from 0.15mg (minimum) to 0.75mg (maximum) in every 100 grams, and this was determined 0.5 mg for the sample used in the present study, indicating a good quality (15).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male-factor infertility (defined as total sperm motility<40% and sperm motility<20%)
- •Normal hormonal profile in women
- •Normal hysterosalpingography report
- •Regular sexual relationships
排除标准
- •Ovulation dysfunction
- •History of sexually transmitted diseases in women and men
- •Hormonal disorders in men and women
研究组 & 干预措施
IUI group
The study subjects included in IUI group were healthy women who had husbands with male-factor infertility problems.
干预措施: IUI (Procedure)
Royal jelly
The study subjects included healthy women who had husbands with male-factor infertility problems.
干预措施: Royal jelly (Other)
结局指标
主要结局
Occurrence of pregnancy
时间窗: Three months after intervention
Occurrence of pregnancy be detected by B-HCG test
次要结局
- confirmation of pregnancy(Three months after intervention)
研究者
Narjes Bahri
Dr Narjes Bahri
Gonabad University of Medical Sciences