The Effect of Royal Vaginal Gel Compared to IUI Technique on Fertility Rate of Women With Low-fertility Husbands

Male Infertility and Complementary 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.

Study Overview

• Status: Completed
• Conditions: Asthenozoospermia
• Intervention / Treatment: Other: Royal jelly; Procedure: IUI

Detailed Description

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
• Enrollment (Actual): 54
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male-factor infertility (defined as total sperm motility<40% and sperm motility<20%)
• Normal hormonal profile in women
• Normal hysterosalpingography report
• Regular sexual relationships

Exclusion Criteria:

• Ovulation dysfunction
• History of sexually transmitted diseases in women and men
• Hormonal disorders in men and women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Complementary group
Active Comparator: IUI group; The study subjects included in IUI group were healthy women who had husbands with male-factor infertility problems.	Procedure: IUI; Subjects in IUI group received 75 units of FSH from the second day of the cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of pregnancy	Occurrence of pregnancy be detected by B-HCG test	Three months after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
confirmation of pregnancy	Abdominal sonography to approve pregnancy and visit embryo sac.	Three months after intervention

Collaborators and Investigators

• Sponsor: Gonabad University of Medical Sciences
• Collaborators: Mashhad University of Medical Sciences
• Investigators: Study Director: Tahereh Fathi Najafi, Instructor, Midwifery department, Islamic Azad Medical University, Mashhad branc, Mashhad, Iran

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): September 20, 2017
• Study Completion (Actual): December 10, 2017

Study Registration Dates

• First Submitted: February 18, 2018
• First Submitted That Met QC Criteria: March 6, 2018
• First Posted (Actual): March 13, 2018

Study Record Updates

• Last Update Posted (Actual): March 13, 2018
• Last Update Submitted That Met QC Criteria: March 6, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility, Male; Infertility; Asthenozoospermia; Anti-Infective Agents; Propolis
• Other Study ID Numbers: 921175

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No