Skip to main content
OpenTrials
Completed

NCT Number: NCT03463005

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Asthenozoospermia Genital Diseases Genital Diseases, Male Infertility Infertility, Male Male Urogenital Diseases Urogenital Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Royal jelly

Other

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

IUI

Procedure

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

Primary outcomes

  1. Occurrence of pregnancy

    Time frame: Three months after intervention

    Occurrence of pregnancy be detected by B-HCG test

Secondary outcomes

  1. confirmation of pregnancy

    Time frame: Three months after intervention

    Abdominal sonography to approve pregnancy and visit embryo sac.

Sponsors and collaborators

Lead sponsor

Gonabad University of Medical Sciences

Other

Collaborators

  • Mashhad University of Medical Sciences

Registry information

Official study title

Male Infertility and Complementary Treatment

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 13, 2018
Registry last updated
Mar 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.