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

NCT03463005 | Completed DMC

• 1 other identifier: 921175
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asthenozoospermia

Outcome Measures

Primary Outcomes (1)

• Occurrence of pregnancy

  Occurrence of pregnancy be detected by B-HCG test

  Three months after intervention

Secondary Outcomes (1)

• confirmation of pregnancy

  Three months after intervention

Study Arms (2)

Royal jelly

EXPERIMENTAL

The study subjects included healthy women who had husbands with male-factor infertility problems.

Other: Royal jelly

IUI group

ACTIVE COMPARATOR

The study subjects included in IUI group were healthy women who had husbands with male-factor infertility problems.

Procedure: IUI

Interventions

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.

Also known as: Complementary group

Royal jelly

IUI PROCEDURE

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

IUI group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male-factor infertility (defined as total sperm motility\<40% and sperm motility\<20%)
• Normal hormonal profile in women
• Normal hysterosalpingography report
• Regular sexual relationships

You may not qualify if:

• Ovulation dysfunction
• History of sexually transmitted diseases in women and men
• Hormonal disorders in men and women

Sponsors & Collaborators

• Gonabad University of Medical Sciences: lead
• Mashhad University of Medical Sciences: collaborator

MeSH Terms

Conditions

Asthenozoospermia

Interventions

royal jelly

Condition Hierarchy (Ancestors)

Infertility, Male; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Study Officials

• Tahereh Fathi Najafi, Instructor

  Midwifery department, Islamic Azad Medical University, Mashhad branc, Mashhad, Iran

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Narjes Bahri

Model Details: 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.

Study Record Dates

• First Submitted: February 18, 2018
• First Posted: March 13, 2018
• Study Start: January 1, 2016
• Primary Completion: September 20, 2017
• Study Completion: December 10, 2017
• Last Updated: March 13, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share