Pioglitazone hydrochloride in combination with clomiphen citrate (CC) in ovulation and pregnancy induction among patients with polycystic ovary syndrome: A randomized, placebo controlled study
This is a double blind clinical trial with the aim of comparison of combination therapy of clomiphen citrate with pioglytazone or placebo in induction of ovulation and pregnancy among patients with poly cystic ovary syndrome. This study will be conducted in Hormozgan University of Medical Sciences in 2013. Study population are all of the patients with confirmed polycystic ovary syndrome. Estimated sample size is 49 patients. Inclusion criteria consisting patients aged between 18 and 35 years and with history of anovulatory cycles during past two months in addition to one of the following conditions: Serum progestrone level less than 5 mg during the mid-luteal phase; Hirsutism; Positive response to medroxy-progesterone acetate withdrawal test ; Serum testosterone level higher than 65 Ng/Dl
Exclusion criteria comprising patients with confirmed diabetes mellitus or fasting blood glucose higher than 125 mg/dl; congenital adrenal hyperplasia which was confirmed by 17-alpha hydroxy progesterone level of 200 ng/dl or higher; patients with underlying disorders such as thyroid disease; hyperprolactinemia; congenital heart disease; hypertension; renal and liver dysfunction; patients who had received any hypoglycemic agent or inducing ovulation medications during 30days ago. All of the participants provided informed consent.
The participants will be followed up for 3 months, ovulation and pregnancy rate among the both groups will be documented. The complications of these methods also, will be recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013071013932N1
Registration date:2013-09-14, 1392/06/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-09-14, 1392/06/23
Registrant information
Name
Seyed Shojaeddin Namazi
Name of organization / entity
Hormozgan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 1333 4190
Email address
ssh.namazi@gmail.com
Recruitment status
Recruitment complete
Funding source
Hormozgan University of Medical Sciecnes
Expected recruitment start date
2013-03-20, 1391/12/30
Expected recruitment end date
2013-09-23, 1392/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Pioglitazone hydrochloride in combination with clomiphen citrate (CC) in ovulation and pregnancy induction among patients with polycystic ovary syndrome: A randomized, placebo controlled study
Public title
The efficacy of combination therapy of clomiphen citrate and pioglithazone in induction ovulation and pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with history of anovulatory cycles during the past two months in addition to one of the following conditions:Serum progestrone level less than 5 mg during the mid-luteal phase; Hirsutism; Positive response to medroxy-progesterone acetate withdrawal test; Serum testosterone level higher than 65 Ng/Dl
Exclusion criteria; patients with confirmed diabetes mellitus or fasting blood glucose higher than 125 mg/dl; congenital adrenal hyperplasia which was confirmed by 17-alpha hydroxy progesterone level of 200 ng/dl or higher; patients with underlying disorders such as thyroid disease; hyperprolactinemia; congenital heart disease; hypertension; renal and liver dysfunction; patients who had received any hypoglycemic agent or inducing ovulation medications during 30days ago.
Age
From 18 years old to 35 years old
Gender
Female
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
49
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hormozgan University of Medical Science
Street address
Research Council building, Shahid Mohammadi Hospital, Jomhoori Eslami Blvd
City
Bandar Abbas
Postal code
Approval date
2013-08-20, 1392/05/29
Ethics committee reference number
HEc-92-4-25-3
Health conditions studied
1
Description of health condition studied
Poly cystic Ovary Syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic Ovarian Syndrome
Primary outcomes
1
Description
ovulation
Timepoint
one month after intervention
Method of measurement
vaginal bleeding
Secondary outcomes
1
Description
pregnancy
Timepoint
2 month after intervention
Method of measurement
beta human chorionic gonadotropine of serum
Intervention groups
1
Description
All of the patients will be received 4 mg of pioglithazone twice a day for 5 days.
Category
Treatment - Drugs
2
Description
All of the patients will be received 4 mg of pioglithazone twice a day for 5 days after that subjects will be received 50 mg of clomiphen citrate twice a day for 5 days in addition to pioglithazone while, control group will be received a placebo instead of clomiphen in the second 5 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Seyed Shojaeddin Namazi
Street address
City
Bandar Abbas
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hormozgan University of Medical Science
Full name of responsible person
Seyed Shojaeddin Namazi
Street address
Student Research Committee, Research Council, Shahid Mohammadi Hospital, Jomhoori Eslami Blvd
City
Bandar Abbas
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hormozgan University of Medical Science
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hormozgan University of Medical Science
Full name of responsible person
Seyed Shojaeddin Namazi
Position
Student
Other areas of specialty/work
Street address
Student Research Committee, Research Counci Buildingl, Shahid Mohammadi Hospital, Jomhoori Eslami Blvd.
City
Bandar Abbas
Postal code
Phone
+98 76 1335 0218
Fax
Email
ssh.namazi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Seyed Shojaeddin Namazi
Position
Student
Other areas of specialty/work
Street address
Student Research Committee, Research Counci Buildingl, Shahid Mohammadi Hospital, Jomhoori Eslami Blvd.
City
Bandar Abbas
Postal code
Phone
+98 76 1335 0218
Fax
Email
ssh.namazi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)