Effect of fennel supplement versus no supplement on the number of ovarian follicles, the endometrial diameter and ovarian volume in infertile women: a single blind randomized clinical trial
Objectives: To assess the effect of fennel supplement versus no supplement on the number of ovarian follicles, the endometrial diameter and ovarian volume in infertile women. Design: A single blind randomized clinical trial. Setting and conduct: The eligible women who are candidate for IVF and will refer to Infertility Clinic of Fatemiah Hospital during the study period will be enrolled into the trial. Inclusion criteria: (a) being infertile; (b) being candidate for IVF; (c) age of 15 to 45 years. Exclusion criteria: Having severe endometriosis. Intervention group: (a) Routine medications for stimulating ovulation plus oral fennel supplement 10 mg daily for two months; (b) Routine medications for stimulating ovulation plus oral fennel supplement 10 mg daily for two months. Control group: Routine medications for stimulating ovulation for two months. Primary outcome: (a) measuring the number of ovarian follicles before and two months after treatment using ultrasonography; (b) measuring the endometrial diameter before and two months after treatment using ultrasonography; (c) measuring the ovarian volume before and two months after treatment using ultrasonography. Secondary outcome: Nothing. Randomization: The patients will be randomly assigned to intervention groups using block randomization of 9 groups. Blinding: The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as single blind.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201509069014N78
Registration date:2015-09-08, 1394/06/17
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-09-08, 1394/06/17
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2016-11-20, 1395/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of fennel supplement versus no supplement on the number of ovarian follicles, the endometrial diameter and ovarian volume in infertile women: a single blind randomized clinical trial
Public title
Effect of fennel supplement versus no supplement on the number of ovarian follicles, the endometrial diameter and ovarian volume in infertile women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a) being infertile; (b) being candidate for IVF. Exclusion criteria: Having severe endometriosis
Age
From 15 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: The patients will be randomly assigned to intervention groups using block randomization of 9 groups.
Blinding: The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as single blind.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2015-08-17, 1394/05/26
Ethics committee reference number
IR.UMSHA.REC.1394.258
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
measuring the number of ovarian follicles
Timepoint
before and two months after treatment
Method of measurement
using ultrasonography
2
Description
measuring the endometrial diameter
Timepoint
before and two months after treatment
Method of measurement
using ultrasonography
3
Description
measuring the ovarian volume
Timepoint
before and two months after treatment
Method of measurement
using ultrasonography
Secondary outcomes
1
Description
Nothing
Timepoint
Nothing
Method of measurement
Nothing
Intervention groups
1
Description
Routine medications for stimulating ovulation plus oral fennel supplement 10 mg daily for two months
Category
Treatment - Drugs
2
Description
Routine medications for stimulating ovulation plus oral fennel supplement 10 mg daily for two months
Category
Treatment - Drugs
3
Description
Routine medications for stimulating ovulation for two months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Dr Mahnaz Yavangi
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of Public Health
Full name of responsible person
Payam Amini
Position
PhD Student pf Biostatistics
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Phone
+98 81 3838 0090
Fax
Email
payam.amini87@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fatemieh Hospital
Full name of responsible person
Dr Mahnaz Yavangi
Position
Fatemieh Hospital
Other areas of specialty/work
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Postal code
Phone
+98 81 3828 3939
Fax
Email
m_tavangi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)