The effect of cinnamon supplementation on infertility treatment outcomes in infertile women with polycystic ovary syndrome (PCOS) candidate of in vitro-fertilization (IVF): A pilot double blind randomized controlled clinical trial
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General information
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The change in the study entry criteria was initially designed so that only phenotype A patients with PCOS were included in the study, after examining the prevalence rate and the possibility of sampling problems, it was decided that all phenotypes of PCOS patients were included in the study.
The change in the study entry criteria was initially designed so that only phenotype A patients with PCOS were included in the study, after examining the prevalence rate and the possibility of sampling problems, it was decided that all phenotypes of PCOS patients were included in the study.
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تغییر در معیارها ورود به مطالعه، درابتدا طراحی شده بود که فقط فنوتیپ A بیماران مبتلا به PCOS وارد مطالعه شوند، پس از بررسی میزان شیوع و احتمال مشکل در نمونه گیری تصمیم گرفته شده است که تمام فنوتیپ های بیماران مبتلا به PCOS وارد مطالعه شوند.
تغییر در معیارها ورود به مطالعه، درابتدا طراحی شده بود که فقط فنوتیپ A بیماران مبتلا به PCOS وارد مطالعه شوند، پس از بررسی میزان شیوع و احتمال مشکل در نمونه گیری تصمیم گرفته شده است که تمام فنوتیپ های بیماران مبتلا به PCOS وارد مطالعه شوند.
Infertile women with PCOS with phenotype A diagnosed according to the Rotterdam criteria (2), who have all three of the following criteria, including (1) oligomenorrhea or anovulation, (2) hyperandrogenism (clinical or biochemical ng/ dL 80 ≤ serum T level), (3) the presence of polycystic ovaries in ultrasound).
The age range of 18 to 38 year.
Written consent to participate in the study
Infertile women with polycystic ovary syndrome (PCOS) diagnosed according to the Rotterdam criteria who meet at least 2 of the following three criteria including: (1) oligomenorrhea or anovulation, (2) hyperandrogenism (clinical or biochemical ng/ dL 80 ≤ serum T level), (3) the presence of polycystic ovaries in ultrasound).
The age range of 18 to 38 year.
Written consent to participate in the study
Infertile women with polycystic ovary syndrome (PCOS with phenotype A) diagnosed according to the Rotterdam criteria (2), who have all threemeet at least 2 of the following three criteria, including: (1) oligomenorrhea or anovulation, (2) hyperandrogenism (clinical or biochemical ng/ dL 80 ≤ serum T level), (3) the presence of polycystic ovaries in ultrasound). The age range of 18 to 38 year. Written consent to participate in the study
زنان نابارور مبتلا به سندرم تخمدان پلی کیستیک (PCOS) با فنوتیپ A تشخیص داده شده بر اساس معیارهای روتردام (2)، که هر سه معیار زیر را دارا باشند شامل (1) الیگومنوره یا عدم تخمک گذاری، (2) هیپرآندروژنیسم (بالینی یا بیوشیمیایی ng/dL 80≤سطح سرمیT)، (3) وجود نمای تخمدان پلی کیستیک در سونوگرافی) .
محدوده سنی 18 تا 38 سال
رضایت کتبی شرکت در مطالعه
زنان نابارور مبتلا به سندرم تخمدان پلی کیستیک (PCOS) تشخیص داده شده بر اساس معیارهای روتردام، که حداقل 2 مورد از سه معیار زیر را دارا باشند شامل : (1) الیگومنوره یا عدم تخمک گذاری، (2) هیپرآندروژنیسم (بالینی یا بیوشیمیایی ng/dL 80≤سطح سرمیT)، (3) وجود نمای تخمدان پلی کیستیک در سونوگرافی) .
محدوده سنی 18 تا 38 سال
رضایت کتبی شرکت در مطالعه
زنان نابارور مبتلا به سندرم تخمدان پلی کیستیک (PCOS) با فنوتیپ A تشخیص داده شده بر اساس معیارهای روتردام (2)، که هرحداقل 2 مورد از سه معیار زیر را دارا باشند شامل : (1) الیگومنوره یا عدم تخمک گذاری، (2) هیپرآندروژنیسم (بالینی یا بیوشیمیایی ng/dL 80≤سطح سرمیT)، (3) وجود نمای تخمدان پلی کیستیک در سونوگرافی) . محدوده سنی 18 تا 38 سال رضایت کتبی شرکت در مطالعه
Recruitment centers
#1
Name of recruitment center - English: Royan Institute
Name of recruitment center - Persian: پژوهشگاه رویان
Full name of responsible person - English: Maryam Hafezi
Full name of responsible person - Persian: مریم حافظی
Street address - English: No. 12, Shahid Soleimani Highway, Bani Hashem St., East Hafez St., Royan Institute
Street address - Persian: بزرگراه شهید سلیمانی، خیابان بنی هاشم، خیابان حافظ شرقی،پلاک ۱۲، پژوهشگاه رویان
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1165659711
Phone: +98 21 2356 2000
Fax:
Email: maryamhafezi90@gmail.com
Web page address:
Name of recruitment center - English: Royan Institute
Name of recruitment center - Persian: پژوهشگاه رویان
Full name of responsible person - English: Maryam Hafezi
Full name of responsible person - Persian: مریم حافظی
Street address - English: No. 12, Shahid Soleimani Highway, Bani Hashem St., East Hafez St., Royan Institute
Street address - Persian: بزرگراه شهید سلیمانی، خیابان بنی هاشم، خیابان حافظ شرقی، پلاک ۱۲، پژوهشگاه رویان
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1165659711
Phone: +98 21 2356 2000
Fax:
Email: maryamhafezi90@gmail.com
Web page address:
Name of recruitment center - English: Royan Institute Name of recruitment center - Persian: پژوهشگاه رویان Full name of responsible person - English: Maryam Hafezi Full name of responsible person - Persian: مریم حافظی Street address - English: No. 12, Shahid Soleimani Highway, Bani Hashem St., East Hafez St., Royan Institute Street address - Persian: بزرگراه شهید سلیمانی، خیابان بنی هاشم، خیابان حافظ شرقی،پلاک ۱۲، پژوهشگاه رویان City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1165659711 Phone: +98 21 2356 2000 Fax: Email: maryamhafezi90@gmail.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Lotus Royan Charitable Fundation
Name of organization / entity - Persian: صندوق نیکوکاری لوتوس رویان
Full name of responsible person - English: Amirreza Adib Azar
Full name of responsible person - Persian: امیررضا ادیب آذر
Street address - English: Tehran, Shahid Soleimani Highway, Bani Hashem Street, Bani Hashem Street, Shahid Kishori Alley, No. 6, Shahid Kishori Building, 2nd Floor, Unit 4
Street address - Persian: تهران، بزرگراه شهید سلیمانی، خیابان بنی هاشم، میدان بنی هاشم، کوچه شهید کشوری، پلاک 6، ساختمان شهید کشوری، طبقه دوم، واحد 4
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1665659911
Phone: +98 21 2233 8290
Fax:
Email: tejarisazi.royan@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Lotus Royan Charitable Fundation
Name of organization / entity - Persian: صندوق نیکوکاری لوتوس رویان
Full name of responsible person - English: Amirreza Adib Azar
Full name of responsible person - Persian: امیررضا ادیب آذر
Street address - English: Unit 4, 2nd Floor, Shahid Kishori Building, No. 6, Shahid Kishori Alley, Bani Hashem Street, Shahid Soleimani Highway, Tehran
Street address - Persian: تهران، بزرگراه شهید سلیمانی، خیابان بنی هاشم، میدان بنی هاشم، کوچه شهید کشوری، پلاک 6، ساختمان شهید کشوری، طبقه دوم، واحد 4
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1665659911
Phone: +98 21 2233 8290
Fax:
Email: tejarisazi.royan@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Lotus Royan Charitable Fundation Name of organization / entity - Persian: صندوق نیکوکاری لوتوس رویان Full name of responsible person - English: Amirreza Adib Azar Full name of responsible person - Persian: امیررضا ادیب آذر Street address - English: TehranUnit 4, Shahid Soleimani Highway, Bani Hashem Street, Bani Hashem Street2nd Floor, Shahid Kishori AlleyBuilding, No. 6, Shahid Kishori BuildingAlley, 2nd FloorBani Hashem Street, Unit 4Shahid Soleimani Highway, Tehran Street address - Persian: تهران، بزرگراه شهید سلیمانی، خیابان بنی هاشم، میدان بنی هاشم، کوچه شهید کشوری، پلاک 6، ساختمان شهید کشوری، طبقه دوم، واحد 4 City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1665659911 Phone: +98 21 2233 8290 Fax: Email: tejarisazi.royan@gmail.com Web page address:
#2
contact.organization_id:
Name of organization / entity - English: Sagepad Darou Company
Name of organization / entity - Persian: شرکت دارویی ساج پاد دارو
Full name of responsible person - English: Ehsan Nasir al-Islami
Full name of responsible person - Persian: احسان نصیرالاسلامی
Street address - English: Tehran, Koi Nasr St., corner of Shahid Tahmasabi St., plate 2, unit 5
Street address - Persian: تهران، خیابان کوی نصر، نبش خیابان شهید طهماسبی،پلاک ۲ واحد ۵
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1447793496
Phone: +98 912 322 3273
Fax:
Email: sagepadco@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Sagepad Darou Company
Name of organization / entity - Persian: شرکت دارویی ساج پاد دارو
Full name of responsible person - English: Ehsan Nasir al-Islami
Full name of responsible person - Persian: احسان نصیرالاسلامی
Street address - English: Unit 5, Plate 2, Corner of Shahid Tahmasabi Street, Koi Nasr Street, Tehran
Street address - Persian: تهران، خیابان کوی نصر، نبش خیابان شهید طهماسبی، پلاک ۲ واحد ۵
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1447793496
Phone: +98 912 322 3273
Fax:
Email: sagepadco@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Sagepad Darou Company Name of organization / entity - Persian: شرکت دارویی ساج پاد دارو Full name of responsible person - English: Ehsan Nasir al-Islami Full name of responsible person - Persian: احسان نصیرالاسلامی Street address - English: TehranUnit 5, Koi Nasr St.Plate 2, cornerCorner of Shahid Tahmasabi St.Street, plate 2Koi Nasr Street, unit 5Tehran Street address - Persian: تهران، خیابان کوی نصر، نبش خیابان شهید طهماسبی،پلاک ۲ واحد ۵ City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1447793496 Phone: +98 912 322 3273 Fax: Email: sagepadco@gmail.com Web page address:
Protocol summary
Study aim
To evaluate the effect of Cinnamon supplementation during controlled ovarian stimulation in patients with polycystic ovary syndrome in a double-blind randomized clinical trial
Design
A double-blind randomized controlled phase III clinical trial with parallel groups of 80 patients, in which the Rand function of Excel software will be used for randomization.
Settings and conduct
This study will be conducted in Royan Institute on patients with polycystic ovary syndrome undergoing in vitro fertilization cycle treatment. The controlled ovarian stimulation method will be the same in all participants using the standard antagonist protocol. Patients will be randomly assigned into two groups using the block method in a size of 6, and each person will be given an exclusive code to keep the allocation hidden. The details of random allocation in terms of drug and placebo grouping are solely at the disposal of the project's pharmacist colleague, who have no role in the process of sampling and follow-up of patients.
Participants/Inclusion and exclusion criteria
All patients diagnosed with polycystic ovary syndrome who are eligible based on the Rotterdam criteria and other inclusion and exclusion criteria stated in the general information section of the clinical trial and who have written consent to participate in the study will be examined.
Intervention groups
In the intervention group, women will take 1500 mg daily (3500 mg cinnamon tablets, Sagepad Darou Pharmaceutical Company, Iran) that is, 4 weeks before the start of the new IVF cycle and 2 weeks during the ovarian stimulation process. The method of ovarian stimulation and placebo consumption in the control group will be completely similar to the intervention group.
Main outcome variables
Total number of retrieved oocytes; Total number of MII oocytes
General information
Reason for update
The change in the study entry criteria was initially designed so that only phenotype A patients with PCOS were included in the study, after examining the prevalence rate and the possibility of sampling problems, it was decided that all phenotypes of PCOS patients were included in the study.
Acronym
IRCT registration information
IRCT registration number:IRCT20080831001141N44
Registration date:2023-10-30, 1402/08/08
Registration timing:prospective
Last update:2023-11-26, 1402/09/05
Update count:2
Registration date
2023-10-30, 1402/08/08
Registrant information
Name
Kiandokht Kiani
Name of organization / entity
Royan Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2230 7960
Email address
kiandokht.kiani@royaninstitute.org
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-21, 1402/08/30
Expected recruitment end date
2025-11-21, 1404/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cinnamon supplementation on infertility treatment outcomes in infertile women with polycystic ovary syndrome (PCOS) candidate of in vitro-fertilization (IVF): A pilot double blind randomized controlled clinical trial
Public title
Investigating the effect of using cinnamon supplements on IVF cycle results in infertile women with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile women with polycystic ovary syndrome (PCOS) diagnosed according to the Rotterdam criteria who meet at least 2 of the following three criteria including: (1) oligomenorrhea or anovulation, (2) hyperandrogenism (clinical or biochemical ng/ dL 80 ≤ serum T level), (3) the presence of polycystic ovaries in ultrasound).
The age range of 18 to 38 year.
Written consent to participate in the study
Exclusion criteria:
Body mass index above 35 kg/m2
Endocrine disorders including diabetes mellitus, hyperprolactinemia, hypertension, Cushing's syndrome
Autoimmune disorders
History of recurrent pregnancy loss
Genital, ovarian or uterine abnormalities
Hydrosalpinx diagnosis
Congenital adrenal hyperplasia, androgen-producing tumors or acromegaly
Sensitivity to cinnamon
Daily and frequent consumption of cinnamon to treat infertility
Severe male factor infertility
Moderate to severe endometriosis diagnosis
Use of other hypoglycemic, insulin-sensitizing drugs (e.g. Metformin) or other antioxidant supplement (e.g. Myo-inositol) and β-blocker before or during the study
Age
From 18 years old to 38 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization allocation will be prepared by the methodologist using the Rand function of Excel software. In this method, the blocks in a size of 6 are used and each person will be given an exclusive code in order to hide the allocation. The details of random allocation in terms of drug and placebo grouping are solely at the disposal of the project's pharmacist colleague, who have no role in the process of sampling and follow-up of patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
The medicine packages, as well as the appearance and smell of cinnamon and placebo tablets, are completely similar to each other. The methodologist prepared the drugs based on the block randomization method and prepared the coded list and put an English three-letter code label on the medicine cans. When an eligible patient is referred to a clinical physician, the principal investigator provides him with an envelope containing a drug code based on a randomized list, and the drug package with the same code is delivered to the patient. In this way, the patient and the clinical doctor following the patient will not know the type of drug (cinnamon or placebo).
Day of oocyte pick-up, 32-34 hours after hCG administration (approximately day 10 of ovarian stimulation)
Method of measurement
At the point of ovum pick-up, the total number of retrieved oocytes is counted by the embryologist. Therefore, it will be possible to measure the results one hour after oocytes retrieval.
2
Description
Total number of mature (MII) oocytes
Timepoint
Day of oocyte pick-up, 32-34 hours after hCG administration (approximately day 10 of ovarian stimulation)
Method of measurement
At the point of ovum pick-up, the total number of retrieved oocytes is counted by the embryologist. Therefore, it will be possible to measure the results one hour after oocytes retrieval.
3
Description
Oocyte recovery ratio
Timepoint
Day of oocyte pick-up, 32-34 hours after hCG administration (approximately day 10 of ovarian stimulation)
Method of measurement
This ratio is obtained by dividing the total number of retrieved oocytes by the total number of aspirated follicles from both ovaries.
4
Description
Oocyte maturity rate
Timepoint
Day of oocyte pick-up, 32-34 hours after hCG administration (approximately day 10 of ovarian stimulation)
Method of measurement
This ratio is calculated by dividing the number of mature oocytes (MII) obtained by the total number of retrieved oocytes from both ovaries.
Secondary outcomes
1
Description
Fertilization rate
Timepoint
17-18 h after intracytoplasmic sperm injection and/or in-vitro insemination by checking the number of polar bodies and pronuclei
Method of measurement
The fertilization rate is defined as the ratio between the number of diploid zygotes and the number of mature oocytes.
2
Description
Quality of obtained embryos
Timepoint
3 days after intracytoplasmic sperm injection or in vitro fertilization (IVF/ICSI) procedure
Method of measurement
Embryo grade is assessed under an inverted microscope 3 days after the intracytoplasmic sperm injection procedure. The quality of embryos is graded from 1 to 3 under inverted microscope 3 days after the intracytoplasmic sperm injection procedure. Embryos with even-sized blastomeres and/or ≤10% fragments is classified as Grade 1 (Excellent or good quality). Grade 2 embryos (moderate or fair quality) have blastomeres with slightly-moderate size differences and/or 10- 20% fragments. Grade 3 embryos (poor quality) have markedly different-sized blastomeres and/or >20% fragments.
Intervention groups
1
Description
Intervention group: patients will take 1500 mg daily (3 tablets of cinnamon 500 mg, Sagepad Darou Pharmaceutical Company, Iran) that is, 4 weeks before the start of the new IVF cycle and 2 weeks during the ovarian stimulation process.
Category
Treatment - Drugs
2
Description
Control group: patients take 3 placebo pills daily (containing white wheat flour, which is similar to cinnamon pills in terms of size, shape, color and smell, Sagepad Darou Pharmaceutical Company, Iran) 4 weeks before starting the ovarian stimulation/in vitro fertilization (COS/IVF) cycle and 2 weeks during the ovarian stimulation procedure, the ovary will be stimulated.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Royan Institute
Full name of responsible person
Maryam Hafezi
Street address
No. 12, Shahid Soleimani Highway, Bani Hashem St., East Hafez St., Royan Institute
City
Tehran
Province
Tehran
Postal code
1165659711
Phone
+98 21 2356 2000
Email
maryamhafezi90@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Lotus Royan Charitable Fundation
Full name of responsible person
Amirreza Adib Azar
Street address
Unit 4, 2nd Floor, Shahid Kishori Building, No. 6, Shahid Kishori Alley, Bani Hashem Street, Shahid Soleimani Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1665659911
Phone
+98 21 2233 8290
Email
tejarisazi.royan@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Lotus Royan Charitable Fundation
Proportion provided by this source
65
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
Other
2
Sponsor
Name of organization / entity
Sagepad Darou Company
Full name of responsible person
Ehsan Nasir al-Islami
Street address
Unit 5, Plate 2, Corner of Shahid Tahmasabi Street, Koi Nasr Street, Tehran
City
Tehran
Province
Tehran
Postal code
1447793496
Phone
+98 912 322 3273
Email
sagepadco@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Pharmaceutical grant
Proportion provided by this source
35
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Zeynab Siahnouri
Position
Non-faculty pharmacist doctor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
No. 12, Shahid Soleimani Highway, Bani Hashem St., East Hafez St., Royan Institute
City
Tehran
Province
Tehran
Postal code
1165659711
Phone
+98 21 2356 2640
Email
zeynab.nouri@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Royan Institute
Full name of responsible person
maryam Hafezi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 12, Shahid Soleimani Highway, Bani Hashem St., East Hafez St., Royan Institute
City
Tehran
Province
Tehran
Postal code
1165659711
Phone
+98 21 2356 2642
Email
maryamhafezi90@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Arezoo Arabipoor
Position
Reseacher
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No. 12, Shahid Soleimani Highway, Bani Hashem St., East Hafez St., Royan Institute
City
Tehran
Province
Tehran
Postal code
1165659711
Phone
+98 21 2356 2640
Email
arezoo.arabipoor@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
Not applicable
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
The individual data of the participants in the study as well as the data related to the main outcomes of the study without mentioning the names of the patients will be compared and reported between the two groups.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
The study data will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Researchers who intend to write a review and meta-analysis study can access the project data and documentation through correspondence with the project facilitator, whose details are provided on the site
From where data/document is obtainable
To access the documents and raw data, it is necessary to study the administrative correspondence with the research deputy of Royan Institute and correspondence with the respondent whose details have been announced on the site.
What processes are involved for a request to access data/document
6 months after the publication of the article in scientific journals, they can send their request through official correspondence or email with the research deputy of the Royan Institute. Access to the data may take up to one month after the application is submitted.