The aim of clinical trial study was Comparing pregnancy rate with N-acetyl cysteine plus clomiphene citrate versus clomiphene alone in treatment of polycystic ovary syndrome, 70 women referred to Milad infertility center of Mashhad that were diagnosed with polycystic ovary syndrome based on the Rotterdam criteria and had the inclusion criteria for this study. They were chosen and randomly divided into intervention (35 people) and control (35 people) groups. On the third day of the menstrual cycle, after spontaneous menstruation by progesterone, a baseline ultrasonography was performed for all patients. From the third day of the cycle, intervention group received 100 mg Clomiphene (two 50 mg tablets) with 1200 mg N-acetyl cysteine (two 600 mg tablets) produced by Fluid UI MUCIL company for 5 days. The patients in the control group were given only 100 mg clomiphene (two 50 mg tablets) on the third day cycle for 5 days. After taking the medication, the follicles number and diameter and endometrial thickness were examined by transvaginal ultrasonography. After observing a 18 - 20 mm follicle, 5000 units of HCG was injected and 14 days later, the pregnancy was controlled.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016042727638N1
Registration date:2016-10-31, 1395/08/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-10-31, 1395/08/10
Registrant information
Name
Aghdas Abdorazaghnejad
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 8888
Email address
miri.mhamin@gmail.com
Recruitment status
Recruitment complete
Funding source
Research approved budget from the deputy of research and technology of Mashhad University of Medical Sciences
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing pregnancy rate with N-acetyl cysteine plus clomiphene citrate versus clomiphene alone in treatment of polycystic ovary syndrome
Public title
The effect of clomiphene N-acetyl cysteine on the pregnancy rate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: PCO patients having at least two of the three conditions for polycystic ovary syndrome based on Rotterdam criteria; age over 18 years, openness of at least one tubal patency based on HSG; normal spermogram; willingness to cooperate in the studying
Exclusion criteria: changes in the diagnosis of the patience during the research; hyperprolactinemia; hypothyroidism; existence of other endocrine diseases such as Cushing.
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, Vakil Abad Blvd, Azadi Square, Mashhad
City
Mashhad
Postal code
Approval date
2015-09-23, 1394/07/01
Ethics committee reference number
Ir.mums.fm.rec.1394.347
Health conditions studied
1
Description of health condition studied
PCO syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
The number of follicle
Timepoint
12th day of the cycle
Method of measurement
Measuring the number of ovarian follicles by transvaginal ultrasonography
2
Description
Follicle diameter
Timepoint
12th day of the cycle
Method of measurement
Measuring the follicle diameter by transvaginal ultrasonography
3
Description
Endometrial thickness
Timepoint
12th day of the cycle
Method of measurement
Measuring the endometrial thickness by transvaginal ultrasonography
4
Description
pregnancy
Timepoint
14 days after the HCG injection into the uterus
Method of measurement
Measurement The BetaHCG testing by blood tests
Secondary outcomes
empty
Intervention groups
1
Description
intervention group: received 100 mg Clomiphene (two 50 mg tablets) with 1200 mg N-acetyl cysteine (two 600 mg tablets) produced by Fluid UI MUCIL company for 5 days
Category
Treatment - Drugs
2
Description
control group: were given only 100 mg clomiphene (two 50 mg tablets) on the third day of the cycle for 5 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Milad infertility center
Full name of responsible person
Nyyere Khadem
Street address
East Razi Street, Mashhad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice President of Research Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Mashhad University of Medical Sciences, Vakil Abad Blvd, Azadi Square, Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice President of Research Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashad University of Medical Sciences
Full name of responsible person
Aghdas Abdolrazagh Nejad
Position
Resident of gynecological surgery, infertility
Other areas of specialty/work
Street address
Department of Obstetrics and Gynecology, Imam Reza Hospital, The Daneshgah 31, Daneshgah Street
City
Mashhad
Postal code
Phone
+98 51 3854 3031
Fax
Email
miri.mhamin@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashad University of Medical Sciences
Full name of responsible person
Dr. Nyyere Ghomian
Position
Associate Professor
Other areas of specialty/work
Street address
Department of Obstetrics and Gynecology, Imam Reza Hospital, The Daneshgah 31, Daneshgah Street
City
Mashhad
Postal code
Phone
+98 51 3854 3031
Fax
Email
Ghomiann@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
Aghdas Abdolrazagh Nejad
Position
Resident of gynecological surgery, infertility
Other areas of specialty/work
Street address
Department of Obstetrics and Gynecology, Imam Reza Hospital, The Daneshgah 31, Daneshgah Street
City
Mashhad
Postal code
Phone
+98 51 3854 3031
Fax
Email
miri.mhamin@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)