The effect of fennel extract on antimullerian hormone and ultrasound criteria in infertile women with Occult premature ovarian failure: a randomized controlled clinical trial.
To comparison the number of ovarian antral follicles in the group receiving fennel capsules and the control group.
To comparison AMH levels in the group receiving fennel capsules and the control group.
Design
Clinical trial with control group, triple blind, randomized, parallel groups, phase 3 on 60 patients. Randomizer software is used for randomization.
Settings and conduct
In this three-blind clinical trial (participants, researcher and data analyst) patients referred to Al-Zahra infertility clinic of Tabriz underwent trans vaginal ultrasound of the ovary on the third day of menstrual cycle once before the start of the interventionto check the number of antral follicles. Antimullerin hormone level will be assessed on the same day by one expert.
Drug or placebo, is placed in numbered opaque glasses, and in this way, participants will be placed in groups. During the intervention period the participants will receive three fennel capsules with a dose of 30 mg or three placebos daily. will be taken daily orally.
At the end of the second month of the intervention, on the third day of menstruation, AMH tests and trans-vaginal ultrasound will be performed on the participants again.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1) Antimullerian hormone>1 , or reduction of ovarian follicular reserve by transvaginal ultrasound (reduction of antral follicles less than 6 in each ovary)
2) The presence of menstrual cycles
3) Having both ovaries
Exclusion criteria:
1) Using alcohol and cigarrete
2) Obesity, BMI >30
Intervention groups
Intervention group: 30 mg fennel capsules made by Barnj Essens Company will be used.
Control group: They will receive placebo in the form of 60 oral gelatin capsules.
Main outcome variables
Antimullerian hormone levels, number of ovarian antral follicles
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111219008459N15
Registration date:2023-02-05, 1401/11/16
Registration timing:prospective
Last update:2023-02-05, 1401/11/16
Update count:0
Registration date
2023-02-05, 1401/11/16
Registrant information
Name
Shirin Hasanpoor
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
hasanpoorsh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-04, 1402/01/15
Expected recruitment end date
2023-07-06, 1402/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of fennel extract on antimullerian hormone and ultrasound criteria in infertile women with Occult premature ovarian failure: a randomized controlled clinical trial.
Public title
The effect of fennel extract on antimullerian hormone and ultrasound criteria in infertile women with Occult premature ovarian failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1) Evidence suggesting occult premature ovarian failure: antimullerian hormone > 1, or reduction of ovarian follicular reserve by transvaginal ultrasound (reduction of antral follicles less than 6 in each ovary)
2) Presence of menstrual cycles
3) Age 20-40 years
4) Having Both ovaries
5) No other causes of female infertility including fallopian tube disorders, endocrine system disorders and uterine disorders, endometriosis, hyperprolactinemia and sexual disorders based on the patient's medical record.
6) Not using complementary herbal medicines in the last three months
Exclusion criteria:
1) Alcohol consumption and smoking
2) Obesity, BMI >30
3) Willingness to use donated eggs
4) Having a history of cancer, radiotherapy and chemotherapy
5) People with ovarian cysts and uterine myoma
6) People being treated with the antibiotic ciprofloxacin (46)
7) Presence of menopause symptoms (hot flashes, night sweats)
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
This study is a randomized controlled clinical trial.The participants will be randomly assigned to two groups of 30 with an allocation ratio of 1:1 using the block method of four and six. So that all 6 possible ways of placing the participants in a block of four (2 people in the intervention group and 2 people in the control group) and 19 possible positions in a block of 6 (3 people in the intervention group and 3 people in the control group) with the letters I and C that represent the intervention and control groups, respectively, is written and the random series of number of these arrangements (from 1 to 25) was obtained by using www.randomizing.org. The bottles of medicine or placebo will be numbered from 1 to 60 based on the random order obtained. In order to hide the allocation, it will be done by a person not involved in sampling.The received intervention, i.e. drug or placebo, is placed in numbered opaque glasses, and in this way, participants will be placed in groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participants, researcher and data analyst will be unaware of the type of intervention received. The received intervention, i.e. drug or placebo, will be placed in similar opaque glasses (participant blinding). Random allocation and numbering of medicine and placebo bottles will be done by a person not involved in sampling (researcher blinding) and the data analyzer will be unaware of the group allocation (analyzer blinding).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
South Shariati Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5138947979
Approval date
2023-01-28, 1401/11/08
Ethics committee reference number
IR.TBZMED.REC.1401.966
Health conditions studied
1
Description of health condition studied
Occult premature ovarian insufficiency
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Comparison of the number of ovarian antral follicles in the group receiving fennel capsules and the control group
Timepoint
At the beginning of the study (before the start of the intervention) 2 months after the start of the intervention
Method of measurement
Real time transvaginal ultrasound with Madison v20 brand, which is made in South Korea
2
Description
Comparison of AMH levels in the group receiving fennel capsules and the control group
Timepoint
At the beginning of the study (before the start of the intervention) 2 months after the start of the intervention
Method of measurement
AMH laboratory kit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 30 mg fennel capsules manufactured by Barnage Essential Oil Company will be used. One capsule will be consumed daily for 2 months.
Category
Treatment - Drugs
2
Description
Control group: Placebo capsules that are similar in appearance (shape, size, color, etc.) to fennel capsules produced by Barch Essential Oil Company and will be consumed daily by Badmet participants for 3 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
ُِِShirin Hasanpoor
Street address
South Artesh Street-Tabriz city- East Azarbaijan
City
Tabriz
Province
East Azarbaijan
Postal code
05138665793
Phone
+98 41 3553 9161
Email
info@alzahrahosp.tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5168743953
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Maryam Banaei
Position
Ms.c student of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of NURSING and Midwifery, South Shariaty Street
City
Tabriz
Province
East Azarbaijan
Postal code
5168743953
Phone
+98 41 3479 6770
Email
future.maryam@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Maryam Banaei
Position
Ms.c student of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of NURSING and Midwifery, South Shariaty Street
City
Tabriz
Province
East Azarbaijan
Postal code
5168743953
Phone
+98 41 3479 6770
Email
future.maryam@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Maryam Banaei
Position
Ms.c student of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of NURSING and Midwifery, South Shariaty Street
City
Tabriz
Province
East Azarbaijan
Postal code
5168743953
Phone
+98 41 3479 6770
Email
future.maryam@yahoo.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