The Effect of Royal Vaginal Gel Compared to IUI Technique on Fertility Rate of Women With Low-fertility Husbands
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|ClinicalTrials.gov Identifier: NCT03463005|
Recruitment Status : Completed
First Posted : March 13, 2018
Last Update Posted : March 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Asthenozoospermia||Other: Royal jelly Procedure: IUI||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||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.|
|Masking:||None (Open Label)|
|Official Title:||Male Infertility and Complementary Treatment|
|Actual Study Start Date :||January 1, 2016|
|Actual Primary Completion Date :||September 20, 2017|
|Actual Study Completion Date :||December 10, 2017|
Experimental: Royal jelly
The study subjects included healthy women who had husbands with male-factor infertility problems.
Other: Royal jelly
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.
Other Name: Complementary group
Active Comparator: IUI group
The study subjects included in IUI group were healthy women who had husbands with male-factor infertility problems.
Subjects in IUI group received 75 units of FSH from the second day of the cycle.
- Occurrence of pregnancy [ Time Frame: Three months after intervention ]Occurrence of pregnancy be detected by B-HCG test
- confirmation of pregnancy [ Time Frame: Three months after intervention ]Abdominal sonography to approve pregnancy and visit embryo sac.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03463005
|Study Director:||Tahereh Fathi Najafi, Instructor||Midwifery department, Islamic Azad Medical University, Mashhad branc, Mashhad, Iran|