Clinical trial NCT03463005: 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
Overall status: COMPLETED
Phase: NA
Conditions: Asthenozoospermia
Lead sponsor: Gonabad University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Mashhad University of Medical Sciences
First posted: 2018-03-13
Enrollment: 54
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Occurrence of pregnancy
timeFrame: Three months after intervention
Secondary outcomes:
measure: confirmation of pregnancy
timeFrame: Three months after intervention
Other outcomes:
Locations:
Study officials:
affiliation: Midwifery department, Islamic Azad Medical University, Mashhad branc, Mashhad, Iran
name: Tahereh Fathi Najafi, Instructor
role: STUDY_DIRECTOR
References: