An interventional study of Royal jelly and IUI in Asthenozoospermia, sponsored by Gonabad University of Medical Sciences. Completed. Per ClinicalTrials.gov, last updated 2018-03-13.
Sponsored by Gonabad University of Medical Sciences · Not applicable, Interventional, and Treatment
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.
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).
Exclusion Criteria:
The study subjects included healthy women who had husbands with male-factor infertility problems.
Other: Royal jelly
The study subjects included in IUI group were healthy women who had husbands with male-factor infertility problems.
Procedure: IUI
The study subjects in the Royal jelly group used 10 ml of the vaginal Royal jell few minutes before and few minutes after intercourse one day after the end of menstruation for two weeks.
Also known as: Complementary group
Subjects in IUI group received 75 units of FSH from the second day of the cycle.
Occurrence of pregnancy
Occurrence of pregnancy be detected by B-HCG test
Time frame: Three months after intervention
confirmation of pregnancy
Abdominal sonography to approve pregnancy and visit embryo sac.
Time frame: Three months after intervention
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Gonabad University of Medical Sciences