To determine and compare endometrial thickness, number and size of follicles, and successful fertility rate in infertile women treated with Clomiphene Citrate in the fennel intervention group and the control group
Design
A controlled, parallel-group, randomized, phase 0 clinical trial on 60 patients. The randomizer.org website was used for randomization.
Settings and conduct
In this study, infertile women treated with clomiphene citrate B who were referred to the obstetrics and gynecology and infertility clinic were randomly assigned to two intervention groups with fennel capsules and a control group. Demographic characteristics were recorded using a relevant questionnaire and the history of underlying diseases was recorded by the researcher. The endometrial thickness was determined by an obstetrics and gynecology and infertility specialist using an ultrasound device with the specifications of the Honda HS 2600 model. The number of follicles in both ovaries was also evaluated and recorded by the obstetrics and gynecology and infertility specialist using the same ultrasound device.
Participants/Inclusion and exclusion criteria
Inclusion: Infertility for at least 2 years.
Exclusion: Not willing to participate in the study, history of allergy to fennel, allergic asthma, seizures, liver disease, and cancer.
Intervention groups
In both groups, Clomiphene citrate tablets were prescribed one tablet (50 mg per day) daily from the third day of the menstrual cycle to the seventh day (for seven days). In the intervention group, each infertile woman was prescribed two fennel supplement capsules (fennel barrage essential oil capsules) daily in addition to Clomiphene citrate from the first day of the menstrual cycle to the last day.
Main outcome variables
Endometrial thickness; Number of follicles; Successful fertilization rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241118063767N2
Registration date:2024-12-05, 1403/09/15
Registration timing:retrospective
Last update:2024-12-05, 1403/09/15
Update count:0
Registration date
2024-12-05, 1403/09/15
Registrant information
Name
Mansooreh Sadat Mojani Qomi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2641 5547
Email address
mansooreh.moujani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-31, 1402/10/10
Expected recruitment end date
2024-10-21, 1403/07/30
Actual recruitment start date
2023-12-31, 1402/10/10
Actual recruitment end date
2024-09-25, 1403/07/04
Trial completion date
2024-09-25, 1403/07/04
Scientific title
Investigating Efffect of Fennel (Foeniculum vulgare) on Endometrial Thickness in Infertile Women treated with Clomiphene Citrate
Public title
Investigating Effect of Fennel (Foeniculum vulgare) on Endometrial Thickness in Infertile Women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in the study
25-35 years of age
Infertility for at least 2 years
Exclusion criteria:
Unwillingness to participate in the study
History of allergy to fennel plant compounds
People with allergic asthma
Epilepsy
Liver diseases
Cancer
Age
From 25 years old to 35 years old
Gender
Female
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization: The allocation of individuals to groups is done in the form of a four-block random allocation. First, the size of each block is specified (four-block), then the list of blocks is specified with the help of the randomizer.org website and numbers are assigned to them (numbers 1 to 15 for 60 people), and each of the numbers on the list is placed in an envelope for its own treatment allocation. Then, individuals entering the study randomly select envelopes containing numbers between one and 15, and the allocation of individuals to two groups, 1 and 2, is determined based on a list of blocks of four for each number.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, two groups of infertile women were studied. The first group was considered as the control group and was treated only with Clomiphene citrate, and the second group was considered as the intervention group and received fennel capsules in addition to Clomiphene citrate.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Reasearch Ethics Commitees of Islamic Azad Tehran Medical Sciences University
Street address
Yakhchal St., Gholhak, Dr. Shariati Ave.
City
Tehran
Province
Tehran
Postal code
1941933111
Approval date
2024-11-17, 1403/08/27
Ethics committee reference number
IR.IAU.PS.REC.1402.574
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
Endometrial thickness
Timepoint
14 days after starting fennel capsules
Method of measurement
Ultrasound machine with Honda HS 2600 model specifications
Secondary outcomes
1
Description
Number of Follicles
Timepoint
14 Days after consuming Fennel
Method of measurement
The number of follicles in both ovaries by a gynecologist and infertility specialist using an ultrasound device
Intervention groups
1
Description
Intervention group: Clomiphene citrate and fennel capsules
Category
Treatment - Drugs
2
Description
Control group: Clomiphene citrate
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Obstetrics and gynecology office
Full name of responsible person
Maliheh Adineh
Street address
Level 2, No 14, Sa`di St. Darya Blvd., Shahrak-e-Gharb
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Mansooreh Sadat Mojani Qomi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Pharmacy, Dr. Shariati Ave., Yakhchal St.
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0052
Fax
Email
mansooreh.moujani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mansooreh Sadat Mojani Qomi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
aculty of Pharmacy, Dr. Shariati Ave., Yakhchal St.
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0052
Fax
Email
mansooreh.moujani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mansooreh Sadat Mojani Qomi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Pharmacy, Dr. Shariati Ave., Yakhchal St.
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0052
Fax
Email
mansooreh.moujani@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Questionnaires without the names of the participants in the project, along with samples of ultrasound images
When the data will become available and for how long
Access begins after the article is published.
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
In preparing meta-analysis articles
From where data/document is obtainable
mansooreh.moujani@gmail.com
What processes are involved for a request to access data/document
By sending a letter from a reputable research center or university, stating the exact use of the data, an image of the available data will be available via email.