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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
Gonabad University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthenozoospermia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    February 18, 2018
    Last Updated
    March 6, 2018
    Sponsor
    Gonabad University of Medical Sciences
    Collaborators
    Mashhad University of Medical Sciences
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    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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