Protocol summary

Study aim
Determining the effect of pollen on sexual function of infertile couples
Design
A clinical trial with a control and randomization group based on the number table, with parallel and double-blind groups of phase 2, will be performed on 128 people.
Settings and conduct
This double-blind randomized controlled trial (participants and researcher) will be performed on 128 infertile women and their husbands referred to Jahrom Infertility Clinic. In the intervention group, 300 mg capsule of date pollen capsule will be given daily for one month and in the same way to the placebo control group. One month later, the questionnaire will be completed and compared again by the participants.
Participants/Inclusion and exclusion criteria
nfertile women who have not had a history of pregnancy after 12 months of intercourse without the use of contraceptives. Be married and have sex at least once a month, be Iranian, have a basic education, be between the ages of 15 and 49, have not experienced any traumatic or stressful events in the last six months, have no history of hypothyroidism and chronic diseases that affect performance Be sexually effective, addicted to drugs and smoking by the research unit or his wife, allergies to pollen and other medicinal plants
Intervention groups
The experimental group of pollen-date plant diet with a dose of 300 mg in capsules will be given for one month. The control group will be given a placebo capsule at a dose of 300 mg for one month.
Main outcome variables
Sexual desire, sexual arousal, orgasm, relationship satisfaction, intercourse pain, general sexual function in infertile women. Erectile function, desire, orgasm, sexual satisfaction, general satisfaction in infertile women

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200925048834N1
Registration date: 2020-10-07, 1399/07/16
Registration timing: retrospective

Last update: 2020-10-07, 1399/07/16
Update count: 0
Registration date
2020-10-07, 1399/07/16
Registrant information
Name
Fateme Hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5433 1521
Email address
ftm.hoseini25@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-03-15, 1398/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of pollen Capsules on the sexual function of infertile couples referring to the infertility clinic of Jahrom city in 2019
Public title
The effect of pollen Capsules on the sexual function of infertile couples
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile women who have not been pregnant for one year without using any infertility prevention device. Getting married and having sex at least once a month Be Iranian Have basic literacy (reading and writing) Women in research units ranging in age from 15 to 49 years.
Exclusion criteria:
Experience some unfortunate or stressful events in the last six months by the research unit or its spouse Having a history of hypothyroidism and chronic diseases that affect the sexual function of infertile women and their husbands Drug and smoking addiction by the research unit or his / her spouse Allergy to plants and other medicinal plants
Age
From 15 years old to 49 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 128
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling was done by simple random allocation method, a table of random numbers was used to select the units. In this method, first the list of names of all infertile women is obtained, then each of them is assigned a score or number and using The required number of units was selected from the table of random numbers. And 64 couples were placed in each group. The study design will be parallel and both groups will be examined for sexual function. Double blind was also used in this study.
Blinding (investigator's opinion)
Double blinded
Blinding description
It was a double-blind method in which the subjects (participants) and observers did not know who was in which group.
Placebo
Used
Assignment
Parallel
Other design features
There is no case

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Jahrom University of Medical science
Street address
Jahrom university of medical science, motahari blvd , jahrom
City
Jahrom
Province
Fars
Postal code
7414846199
Approval date
2019-10-09, 1398/07/17
Ethics committee reference number
IR.JUMS.REC.1398.049

Health conditions studied

1

Description of health condition studied
sexual function
ICD-10 code
F52.9
ICD-10 code description
Unspecified sexual dysfunction, not caused by organic disorder or disease

Primary outcomes

1

Description
sexual function
Timepoint
Before the intervention and after the end of the one-month period of capsule use
Method of measurement
male sexual function questionnaires and female sexual function questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Experimental group: Diet-pollen (pure) plant diet with a dose of 300 mg in capsules, will be given for one month before the intervention, male sexual function questionnaires will be given to husbands and female sexual function questionnaire will be given to infertile women. One month during the phone call and follow-up questionnaire will be given to individuals to complete the data.
Category
Prevention

2

Description
The control group of placebo at a dose of 300 mg daily in capsules will be given for one month before the intervention. Men's sexual function questionnaires will be given to husbands and women 's sexual function questionnaires will be given to infertile women. Questionnaires will be given to individuals to complete the data
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Infertility Clinic of Jahrom city
Full name of responsible person
Safieh Jamali
Street address
janbazan blvd.
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5423 0012
Email
safieh_jamali@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Kavous Sahljoo
Street address
Motahari blvd, jahrom university of medical science
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5433 6085
Email
pshora2014@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jahrom University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Safieh Jamali
Position
Faculty of Jahrom University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Jahrom. Jahrom university of medical science
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5433 1521
Fax
Email
Ftm.hoseini25@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Safieh Jamali
Position
Faculty of Jahrom University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Jahrom. Jahrom university of medical science
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5423 5529
Fax
Email
Ftm.hoseini25@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Fateme Hosseini
Position
Medical student( intern)
Latest degree
A Level or less
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Jahrom. Jahrom university of medical science
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5433 1521
Fax
Email
Ftm.hoseini25@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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