Role of phyto-oestrogens (Cimicifuga racimosa) in combination with clomiphene citrate on ovulation induction in women with poly-cystic ovarian syndrome, A clinical Trial study
Development of Polycystic Ovarian syndrome Therapy methods
Design
This study is a prospective double-blind clinical trial performed on 100 women with polycystic ovary syndrome attending the Milad Hospital in Mashhad during 2016 to 2017. The randomization will be performed using sealed envelopes in which a green or blue card is placed inside.
Settings and conduct
This study is a double-blind which researcher and patient are unaware of the type of intervention.
Participants will be women with polycystic ovarian syndrome
Participants/Inclusion and exclusion criteria
women with polycystic ovarian syndrome
Intervention groups
The intervention group: cimicifuga racimosa and clomiphene(20 mg) From the second day of the menstrual cycle for 10 days.
Control group: Clomiphene citrate (50 mg) twice a day from the second day of the menstrual cycle for 5 days. It should be repeated three cycles.
Main outcome variables
Endometrium thickness, plasma estradiol
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020264N2
Registration date:2018-01-04, 1396/10/14
Registration timing:retrospective
Last update:2018-01-04, 1396/10/14
Update count:0
Registration date
2018-01-04, 1396/10/14
Registrant information
Name
Seyedeh Azam Pourhoseini
Name of organization / entity
Mashhad University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 51 3847 1446
Email address
pourhoseinia@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of the Faculty of Medical Sciences, Mashhad
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Role of phyto-oestrogens (Cimicifuga racimosa) in combination with clomiphene citrate on ovulation induction in women with poly-cystic ovarian syndrome, A clinical Trial study
Public title
Role of phyto-oestrogens (Cimicifuga racimosa) in combination with clomiphene citrate on ovulation induction in women with polycystic ovarian syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with polycystic ovarian syndrome
Primary and secondary infertility
Normal hysterosalpingography
Normal Spermogram in patients' spouses
Age below 38 years
Exclusion criteria:
History of cardiovascular disease
History of liver disease
History Ovarian masses
Age
From 20 years old to 38 years old
Gender
Female
Phase
2
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization is done using closed envelopes
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-blind study in which the researcher and the person who will analyze the data won't be aware of the type of drug.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical sciences
Street address
Mashhad University of Medical Sciences; International Offic Administration Center(Qoreishi Building) ; Daneshgah St.
City
Mashhad
Province
Fars
Postal code
13944-91388
Approval date
2014-07-23, 1393/05/01
Ethics committee reference number
931151
Health conditions studied
1
Description of health condition studied
polycystic ovarian syndrom
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
plasma estradiol
Timepoint
12 days after intervention
Method of measurement
sonography
Secondary outcomes
1
Description
endometrial thickness
Timepoint
12 days after intervention
Method of measurement
sonography
Intervention groups
1
Description
Intervention group: 20 mg Cimicifuga racimosa twice a day for 10 days with clomiphene citrate 50 mg twice a day for 5 days. The regimen will be started from the second day of the menstrual cycle and will be prescribed for three consecutive cycles.
Category
Treatment - Drugs
2
Description
Control group: clomiphene citrate 50 mg twice a day for 5 days. The regimen will be started from the second day of the menstrual cycle and will be prescribed for three consecutive cycles.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Milad Infertility Center
Full name of responsible person
Maliheh Amirian
Street address
Montserieh Infertility Therapy Research Center, next to Sina Hospital, East Razi Street
City
Mashhad
Province
Fars
Postal code
9135913556
Phone
+98 51 3802 2608
Email
pourhoseinia@mums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahyar Mirheidari
Street address
Mashhad University of Medical Sciences; International Offic Administration Center (Qoreishi Building) ; Daneshgah St., Mashhad. Mashhad
City
Mashhad
Province
Fars
Postal code
9138813944
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
گرانت پژوهشي
Grant code / Reference number
931151
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Malihe Mahmoodo Nia
Position
Resident of Obstetrics and Gynecology
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of Obstetrics and Gynecology, Imam Reza (AS) Hospital, Taghiabad Square
City
Mashhad
Province
Fars
Postal code
9138813944
Phone
+98 51 3802 2608
Fax
Email
mahmodynia@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyedeh Azam Pourhoseini
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of Obstetrics and Gynecology, Imam Reza (AS) Hospital, Taghiabad Square
City
Mashhad
Province
Fars
Postal code
7449389918
Phone
+98 51 3802 2608
Fax
Email
pourhoseinia@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyedeh Azam Pourhoseini
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of Obstetrics and Gynecology, Imam Reza (AS) Hospital, Taghiabad Square
City
Mashhad
Province
Fars
Postal code
7449389918
Phone
+98 51 3802 2608
Fax
Email
pourhoseinia@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Proposal
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
The researchers of Univerities
Under which criteria data/document could be used
Method and conclusion
From where data/document is obtainable
sent email to author
What processes are involved for a request to access data/document