Introduction:In this study we aimed to compare the long-term and short-term doses of letrozole for improving ovulation induction in polycystic ovary syndrome (PCOS)patients also to evaluate the pregnancy outcomes among these patients.
Materials and Methods:This interventional study was conducted at theKosar infertility center of Urmia-Iran in 2015-2016. The study participants included 200 PCOS patients who will be divided randomly into two groups: group I (short-term letrozole group;patients will be received oral letrozole 7.5 mg, from day 3to 7 ofmenstruation) and group II (long-term letrozole group;patients will be received 5mg oral letrozole from day 2or 3o fmenstruation till 10 days (all participants will be received oral letrozole for three menstrual cycles).In the both groups;GONAL-f will injected on days 5, 7, 9 menstrual cycles. Follow up by, transvaginal ultrasound and folliculogram will be performed to follow up follicles size and endometrial thickness.When the follicle size be 18mm or more, HCG (5000 IU) will be injected intramuscular.Participants will undergoing intrauterine insemination(IUI) 24 to 36 hours after HCG injectionand fertility results will be assessed
General information
Acronym
polycystic ovary syndrome
IRCT registration information
IRCT registration number:IRCT2016030926962N2
Registration date:2016-05-08, 1395/02/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-08, 1395/02/19
Registrant information
Name
Tahereh Behroozi Lak
Name of organization / entity
Educational and Treatment Kowsar Center
Country
Iran (Islamic Republic of)
Phone
+98 44 3223 7077
Email address
behroozilak.t@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Urmia University of Medical Sciences
Expected recruitment start date
2016-03-19, 1394/12/29
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy of long-term and short-term doses of letrozole in ovulation induction among patients with polycystic ovary syndrome
Public title
Comparing the efficacy of long-term and short-term doses of letrozole in ovulation induction among patients with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 38-18 years - poly cystic ovary syndrome proven - resistance to clomiphene citrate thyroid -Tested normal - normal prolactin - the absence of other causes of infertility, including male factor - normal Hysterosalpangiography
Exclusion criteria: Ovarian Cysts- Follicle-stimulating hormone> 10 - Patients with Ovarian Hyper stimulation Syndrome
Age
From 18 years old to 38 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
no
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
Urmia, Resalat Blvd. the end of Jahad St. Research ward, Setad, Urmia university of medical sciences
City
Urmia
Postal code
5714783734
Approval date
2013-12-22, 1392/10/01
Ethics committee reference number
ir.umsu.erc.1392.234
Health conditions studied
1
Description of health condition studied
polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
E28.2
Primary outcomes
1
Description
The number of mature follicles.
Timepoint
11 cycle days after intervention
Method of measurement
Vaginal ultrasound
2
Description
Endometrial thickness at the time of HCG injection
Timepoint
11 cycle days after intervention
Method of measurement
Vaginal ultrasound
3
Description
The number of Gonal
Timepoint
After intervantion, days 5, 7 and 9 of the cycle
Method of measurement
Vaginal ultrasound
Secondary outcomes
1
Description
Event Pregnancy
Timepoint
After intervention
Method of measurement
Test BHCG
2
Description
Abortion rate
Timepoint
After intervention
Method of measurement
Clinical and sonographic reports
3
Description
Multiple event
Timepoint
After intervention
Method of measurement
Ultrasound Report
Intervention groups
1
Description
Evaluation of Gonal gonadotropin follicle size (Karma) 75 units, single subcutaneous injection around the belly button
Category
Treatment - Drugs
2
Description
Letrozole group long-term (manufactured by SOHA) that will be received oral letrozole on day 2 or 3 of the cycle up to 10 days for 5 mg (per group of 100 people for 3 cycles)
Category
Treatment - Drugs
3
Description
Short-term letrozole group that will be received oral letrozole on day 3 to 7 of the cycle up to 7.5 mg (per group of 100 people for 3 cycles)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Educational and treatment kowsar center
Full name of responsible person
Tahereh Behroozi Lak
Street address
Research ward, Setad , Urmia university of medical sciences
City
Urmia
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research Urmia University of Medical Sciences
Full name of responsible person
Iraj Mohebbi
Street address
Urmia, Resalat Blvd. the end of Jahad St. Research ward, Setad, Urmia university of medical sciences
City
Urmia
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 Urmia 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
Urmia University of Medical Sciences
Full name of responsible person
Tahereh Behroozi Lak
Position
Assistant Professor
Other areas of specialty/work
Street address
Urmia, Resalat Blvd. the end of Jahad St. Research ward, Setad, Urmia university of medical sciences
City
Urmia
Postal code
Phone
+98 44 3223 7077
Fax
Email
t.behrooz2@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Educational and treatment kowsar center
Full name of responsible person
Tahereh Behroozi Lak
Position
Assistant Professor
Other areas of specialty/work
Street address
Urmia, Resalat Blvd. the end of Jahad St. Research ward, Setad, Urmia university of medical sciences
City
Urmia
Postal code
Phone
+98 44 3223 7077
Fax
Email
t.behrooz2@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Tahereh Behroozi Lak
Position
Assistant Professor
Other areas of specialty/work
Street address
Urmia, Resalat Blvd. the end of Jahad St. Research ward, Setad, Urmia university of medical sciences
City
Urmia
Postal code
Phone
+98 443223077
Fax
Email
t.behrooz2@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)