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Effects of extract of Foeniculum vulgare on serum levels of estrogen, progesterone, LH and FSH hormones and miR-499, BMP15 and GDF9 genes expression in granulosa cells of patients with polycystic ovary syndrome (PCOS)

Protocol summary

Study aim
To evaluate the effects of an extract of Foeniculum vulgare on serum levels of estrogen, progesterone, LH, and FSH hormones and miR-499, BMP15, and GDF9 genes expression in granulosa cells of patients with the polycystic ovarian syndrome(PCOS)
Design
Randomized, parallel-group, single-blind, controlled, phase 2-3 clinical trial on 45 patients.
Settings and conduct
The study was conducted in the infertility treatment center of Besat Hospital, Sanandaj, where 45 patients were randomly divided into three groups. In this study, only the laboratory technician did not know about the grouping of patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria: PCOS patients (experimental group): at least 10 cysts with a diameter of 2-8 mm around the central stroma, (Adams criteria), menstrual cycle disorder, clinical symptoms, and detection of polycystic ovaries in ultrasound(Rotterdam diagnostic criteria). Exclusion criteria: over 35 and under 20 years of age, Cushing's syndrome, weight-induced amenorrhea, pituitary diseases, congenital adrenal hyperplasia , prolactinoma, thyroid disorders, androgen-secreting tumors, hypertension, chronic kidney disease, alcoholics, and smokers.
Intervention groups
3 groups of 15 people (1: control group 2: experimental group). The experimental group: women with PCOS were treated with ICSI/ IVF and then they were divided into two groups (treated with fennel extract and not treated with fennel extract).
Main outcome variables
1) Change in the serum level of FSH hormone 2) Changes in the serum level of LH hormone 3) Change in progesterone serum level 4) Changes in serum estrogen levels 5) Changing the expression of miRNA-499 6) Changing the expression of GDF9 7) Changing the expression of BMP-15

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200908048665N1
Registration date: 2023-06-01, 1402/03/11
Registration timing: retrospective

Last update: 2023-06-01, 1402/03/11
Update count: 0
Registration date
2023-06-01, 1402/03/11
Registrant information
Name
Azra allahveisi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3366 4673
Email address
allavaisie@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2023-07-23, 1402/05/01
Actual recruitment start date
2020-11-21, 1399/09/01
Actual recruitment end date
2023-05-22, 1402/03/01
Trial completion date
2023-06-22, 1402/04/01
Scientific title
Effects of extract of Foeniculum vulgare on serum levels of estrogen, progesterone, LH and FSH hormones and miR-499, BMP15 and GDF9 genes expression in granulosa cells of patients with polycystic ovary syndrome (PCOS)
Public title
Effects of extract of Foeniculum vulgare on patients with polycystic ovary syndrome (PCOS)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
According to the Adams criteria based on ovarian ultrasound manifestations is to have at least 10 cysts with a diameter of 2-8 mm around the central stroma, densely and in the form of a necklace. Having Rotterdam diagnosis criteria (menstrual cycle disorder, clinical symptoms, and diagnosis of polycystic ovary in ultrasound diagnosed by a radiology specialist and infertility fellowship). BMI between 18-22 Age between 20-35 years
Exclusion criteria:
Patients with Cushing's syndrome and weight-induced amenorrhea Pituitary disorders Congenital Adrenal Hyperplasia (CAH) Prolactinoma Thyroid disorders Androgen-secreting tumors Hypertension Chronic kidney disease Alcoholics and smokers Previous miscarriage Infertility in their husbands
Age
From 20 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 45
More than 1 sample in each individual
Number of samples in each individual: 15
The studied participants included 3 groups of 15 people. The intervention group included patients with polycystic ovary syndrome who were treated with fennel extract. A control group including women who had infertility problems in their spouses and another group including women with polycystic ovaries without treatment with fennel were selected as the second control group.
Actual sample size reached: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Individual block randomization was considered by considering fifteen blocks and within each block three groups (A, B, and C) whose order was set randomly. So, finally, the list of 45 people who were assigned to each group was placed in 45 sealed envelopes, with numbers 1 to 45 written on the envelopes, and the study group was recorded inside the envelopes. The arrangement of the groups was done based on the block allocation by the website https://www.sealedenvelope.com.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, only the person investigating the results (hormones and expression of desired genes) in the laboratory did not know about the grouping of the patients, but the patients and the researchers were aware of the grouping.
Placebo
Used
Assignment
Parallel
Other design features
In this study, the level of hormones LH, FSH, estrogen, progesterone and the expression level of 499-miR and BMP15 and GDF9 genes in granulosa cells of women with polycystic ovary syndrome as well as two healthy groups and patients without intervention were investigated. The desired measurements were performed before and after the intervention group, but only baseline values were measured in the other two groups. All measurements were among the routine measures for patients presenting with infertility complaints.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kurdistan University of Medical Sciences
Street address
Sanandaj - Pasdaran Ave
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Approval date
2021-02-17, 1399/11/29
Ethics committee reference number
IR.MUK.REC.1399.141

Health conditions studied

1

Description of health condition studied
polycystic ovary syndrome (PCOS)
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome

Primary outcomes

1

Description
Serum level of estrogen hormone
Timepoint
Before starting the study and before IVF in three groups and after the intervention in the experimental group (After taking 45 days of ethanol extract of fennel plant)
Method of measurement
ELISA test

2

Description
Serum levels of progesterone
Timepoint
Before starting the study and before IVF in three groups and after the intervention in the experimental group (After taking 45 days of ethanol extract of fennel plant)
Method of measurement
ELISA test

3

Description
FSH serum level
Timepoint
Before starting the study and before IVF in three groups and after the intervention in the experimental group (After taking 45 days of ethanol extract of fennel plant)
Method of measurement
ELISA test

4

Description
LH serum level
Timepoint
Before starting the study and before IVF in three groups and after the intervention in the experimental group (After taking 45 days of ethanol extract of fennel plant)
Method of measurement
ELISA test

5

Description
The expression level of 499-miR
Timepoint
Before starting the study and before IVF in three groups and after the intervention in the experimental group (After taking 45 days of ethanol extract of fennel plant)
Method of measurement
Real time PCR

6

Description
BMP15 gene expression
Timepoint
Before starting the study and before IVF in three groups and after the intervention in the experimental group (After taking 45 days of ethanol extract of fennel plant)
Method of measurement
Real time PCR

7

Description
GDF9 gene expression
Timepoint
Before starting the study and before IVF in three groups and after the intervention in the experimental group (After taking 45 days of ethanol extract of fennel plant)
Method of measurement
Real time PCR

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: women with polycystic ovary syndrome (PCOS) treated with fennel extract in the amount of 100 mg twice a day in the form of capsules made by the research group.
Category
Treatment - Other

2

Description
Control group: This group was given a placebo in the form of capsules similar to the intervention group, which contained starch, twice a day for 45 days.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat hospital
Full name of responsible person
Borhan Morad Veisi
Street address
Keshavarz Ave ،Basat hospital
City
Sanandaj
Province
Kurdistan
Postal code
4533335567
Phone
+98 87 3328 2002
Email
besathospital@muk.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Afshin Maleki
Street address
Pasdaran Ave, Medical University Kurdistan
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4645
Fax
Email
info@muk.ac.ir
Web page address
http://www.muk.ac.ir/
Grant name
Maleki
Grant code / Reference number
1399.141
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Rojin Ramezani
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
Medical Education
Street address
Pasdaran st., Medical Sciences, Razi Alley 6
City
Sanandaj
Province
Kurdistan
Postal code
6616945457
Phone
+98 87 3361 1017
Email
Rojin.Ramezani@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Rojin Ramezani
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Pasdaran St., Medical Sciences, Razi Alley 6
City
Sanandaj
Province
Kurdistan
Postal code
6616945457
Phone
+98 87 3361 7101
Email
Rojin.Ramezani@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Rojin Ramezani
Position
Medical Etudent
Latest degree
A Level or less
Other areas of specialty/work
Medical Education
Street address
Pasdaran St., Medical Sciences, Razi Alley 6
City
Sanandaj
Province
Kurdistan
Postal code
6616945457
Phone
+98 87 3316 1071
Email
Rojin.Ramezani@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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Row data will be available.
When the data will become available and for how long
After publication
To whom data/document is available
Researchers
Under which criteria data/document could be used
For systematic review and meta-analysis.
From where data/document is obtainable
Research deputy at Kurdistan University of Medical Sciences
What processes are involved for a request to access data/document
Send a request to the research deputy at the University
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