Clinical Trials Comparison Time of Administration of Clomiphene Citrate on Follicular Growth, Endometrial Thickness, Ovulation and Pregnancy Rates in Polycystic Ovary Syndrome Patients
This clinical trial study aimed to compare the onset of clomiphene citrate at the luteal phase and the third menstrual day, and its effect on the growth of ovarian follicles, endometrial thickness and rate of ovulation and pregnancy in 115 women with polycystic ovary syndrome referred to Fatemeh Zahra Infertility Center of Babol. All patients were received 10 mg of medroxyprogesterone acetate 14 days after period for 10 days, then patients were randomly divided into two groups based on random numbers table. The patients in intervention group (55 Patients) was received 100 mg clomiphene for 5 days at the luteal phase immediately after completion of medroxyprogesterone and in the control group (60 Patients) at the third menstrual, and on day 11 of the cycle, transvaginal ultrasound was done for all patients. If there was at least a follicule larger than 18 mm, 10 thousand units of Human chorionic gonadotropin was injected intramuscularly. The preliminary results including the follicular growth and endometrial thickness and number of dominant follicles and Secondary outcomes including pregnancy and abortion were compared in the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016052125292N4
Registration date:2016-09-01, 1395/06/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-09-01, 1395/06/11
Registrant information
Name
Sedigheh Smaeilzadeh
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3223 8301
Email address
crdu.rohan@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Babol University of Medical Science
Expected recruitment start date
2012-03-19, 1390/12/29
Expected recruitment end date
2013-03-19, 1391/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Trials Comparison Time of Administration of Clomiphene Citrate on Follicular Growth, Endometrial Thickness, Ovulation and Pregnancy Rates in Polycystic Ovary Syndrome Patients
Public title
Effect Time of Administration of Clomiphene citrate on the Fertility of patients with Polycystic Ovary Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with Polycystic Ovary Syndrome and undergoing Intrauterine insemination; Age 18 to 35 years; duration of infertility less than 5 years; normal hysterosalpingography and normal spermogram; No previous use of gonadotropin
Exclusion criteria: Follicle-stimulating hormone base of more than or equal to 14; Ovarian pathology; There is an ovary; Absence due to male factor infertility; endometriosis; tubal obstruction
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
115
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
Ethics Committee of Babol University of Medical Science
Street address
Ganj Afrouz Street
City
Babol
Postal code
Approval date
2012-03-03, 1390/12/13
Ethics committee reference number
MUBABOL.REC.1390.13
Health conditions studied
1
Description of health condition studied
polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
polycystic ovarian syndrome
Primary outcomes
1
Description
On Follicular Growth, Endometrial Thickness and Ovulation
Timepoint
11 day menstrual cycle
Method of measurement
With transvaginal sonography in millimeters
Secondary outcomes
1
Description
Pregnancy
Timepoint
16 days after injection of Human Chorionic Gonadotropin
Method of measurement
B-Human Chorionic Gonadotropin test serum
Intervention groups
1
Description
Intervention group: The patients was received 100 mg clomiphene for 5 days at the luteal phase immediately after completion of medroxyprogesterone
Category
Treatment - Drugs
2
Description
Control group: The patients was received 100 mg clomiphene for 5 days at the third menstrual
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Center of fertility infertility Fateme Zahra of Babol
Full name of responsible person
Mohadeseh Mahdavi
Street address
Above the bridge Mohammah Hassan Khan, Tork Mahaleh
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Babol University of Medical Science
Full name of responsible person
Mahmoud Babaie
Street address
Iran- Babol -Ganj Afrouz Street
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Babol 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
Name of organization / entity
Babol University of Medical Science
Full name of responsible person
Mohadeseh Mahdavi
Position
MD
Other areas of specialty/work
Street address
Iran- Babol- Ganj Afrouz Street
City
Babol
Postal code
Phone
+98 11 3223 8301
Fax
Email
mojy_rad@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Science
Full name of responsible person
Mahtab Zeinalzadeh
Position
Obstetrician and Gynecologist
Other areas of specialty/work
Street address
Ganj Afrouz Street- Babol- Iran
City
Babol
Postal code
Phone
+98 911 114 1577
Fax
Email
zeinalmahtab@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Science
Full name of responsible person
Mohadeseh Mahdavi
Position
MD
Other areas of specialty/work
Street address
Ganj Afrouz Street- Babol-Iran
City
Babol
Postal code
Phone
+98 11 3223 8301
Fax
Email
mojy_rad@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)