The Effect of Royal Vaginal Gel Compared to IUI Technique on Fertility Rate of Women With Low-fertility Husbands
Primary Purpose
Asthenozoospermia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Royal jelly
IUI
Sponsored by
About this trial
This is an interventional treatment trial for Asthenozoospermia
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Royal jelly
IUI group
Arm Description
The study subjects included healthy women who had husbands with male-factor infertility problems.
The study subjects included in IUI group were healthy women who had husbands with male-factor infertility problems.
Outcomes
Primary Outcome Measures
Occurrence of pregnancy
Occurrence of pregnancy be detected by B-HCG test
Secondary Outcome Measures
confirmation of pregnancy
Abdominal sonography to approve pregnancy and visit embryo sac.
Full Information
NCT ID
NCT03463005
First Posted
February 18, 2018
Last Updated
March 6, 2018
Sponsor
Gonabad University of Medical Sciences
Collaborators
Mashhad University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03463005
Brief Title
The Effect of Royal Vaginal Gel Compared to IUI Technique on Fertility Rate of Women With Low-fertility Husbands
Official Title
Male Infertility and Complementary Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
September 20, 2017 (Actual)
Study Completion Date
December 10, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gonabad University of Medical Sciences
Collaborators
Mashhad University of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthenozoospermia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Non-Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Royal jelly
Arm Type
Experimental
Arm Description
The study subjects included healthy women who had husbands with male-factor infertility problems.
Arm Title
IUI group
Arm Type
Active Comparator
Arm Description
The study subjects included in IUI group were healthy women who had husbands with male-factor infertility problems.
Intervention Type
Other
Intervention Name(s)
Royal jelly
Other Intervention Name(s)
Complementary group
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
IUI
Intervention Description
Subjects in IUI group received 75 units of FSH from the second day of the cycle.
Primary Outcome Measure Information:
Title
Occurrence of pregnancy
Description
Occurrence of pregnancy be detected by B-HCG test
Time Frame
Three months after intervention
Secondary Outcome Measure Information:
Title
confirmation of pregnancy
Description
Abdominal sonography to approve pregnancy and visit embryo sac.
Time Frame
Three months after intervention
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tahereh Fathi Najafi, Instructor
Organizational Affiliation
Midwifery department, Islamic Azad Medical University, Mashhad branc, Mashhad, Iran
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Royal Vaginal Gel Compared to IUI Technique on Fertility Rate of Women With Low-fertility Husbands
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