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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
Sponsor:
Collaborator:
Mashhad University of Medical Sciences
Information provided by (Responsible Party):
Narjes Bahri, Gonabad University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Asthenozoospermia Other: Royal jelly Procedure: IUI Not Applicable

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  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Non-Randomized
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)
Primary Purpose: Treatment
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


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 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.
Procedure: IUI
Subjects in IUI group received 75 units of FSH from the second day of the cycle.




Primary Outcome Measures :
  1. Occurrence of pregnancy [ Time Frame: Three months after intervention ]
    Occurrence of pregnancy be detected by B-HCG test


Secondary Outcome Measures :
  1. confirmation of pregnancy [ Time Frame: Three months after intervention ]
    Abdominal sonography to approve pregnancy and visit embryo sac.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


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

Responsible Party: Narjes Bahri, Dr Narjes Bahri, Gonabad University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03463005     History of Changes
Other Study ID Numbers: 921175
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Asthenozoospermia
Infertility, Male
Infertility
Genital Diseases, Male
Propolis
Anti-Infective Agents