118 clomiphene-resistant PCOS patients with normal TSH, PRL, spermogram and HSG who were referred to Milad infertility center were randomly allocated into two 59 number groups; groups randomly allocated basis two packets A and B. Group 1 received 5 mg daily from 3 th menstrual cycle for 5 day and HMG 75 u daily in 9th and 10th cycle and group 2 received letrozole 5 mg daily from 3rd menstrual cycle for 5 day and Gonal-f (recombinant FSH) 75 u daily in 9th and 10th cycle. From the 10th follicle number and size and endometrial thickness were evaluated by transvaginal sonography. HCG was administered if at least one mature follicle (>18mm) was observed and IUI was performed 36 h later. Vaginal suppository progesterone was used daily for luteal phase support. In this study, the primary outcomes were the positive pregnancy test and observe of gestational sac and fetal heart activity which were seen by abdominal ultrasound. Secondary outcomes were dominant follicle, endometrial thickness and abortion.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201703153950N6
Registration date:2017-05-20, 1396/02/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-05-20, 1396/02/30
Registrant information
Name
Mina Jafarabadei
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1616
Email address
jafarabadi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2016-04-03, 1395/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of letrozole combined FSH and letrozole combined HMG in infertile polycystic ovarian syndrome patients undergoing iui cycle
Public title
Comparison the effect of letrozole combined FSH and letrozole combined HMG in induction ovulation.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: PCOS patient; patency at least one fallopian tube; normal semen analysis in male; age between 20-40 years old.
Exclusion criteria: addiction and cigarette use; unsatisfaction for the participation of study; history of previous disease.
Age
From 20 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
118
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Mashhad University of Medical Sciences
Street address
Vice Chancellor for research, Mashhad University of Medical sciences، near the Hoveizeh Cinema, Daneshgah Street, Mashhad.
City
Mashhad
Postal code
9189757565
Approval date
2015-08-01, 1394/05/10
Ethics committee reference number
IR.MUMS.IKHC.REC.1394.311
Health conditions studied
1
Description of health condition studied
Female infertility associated with anovulation
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation
Primary outcomes
1
Description
Chemical pregnancy
Timepoint
14 days after IUI
Method of measurement
Blood sample
2
Description
Clinical pregnancy
Timepoint
one week after positive the blood sample.
Method of measurement
Sonography
Secondary outcomes
1
Description
Follicle larger than 18 mm
Timepoint
14 th day of the menstural cycle
Method of measurement
Transvaginal sonography
2
Description
Endometrial Thickness
Timepoint
14 th day of the menstural cycle
Method of measurement
Transvaginal sonography
3
Description
Abortion incidance
Timepoint
After to positive of pregnancy test
Method of measurement
Transvaginal sonography
Intervention groups
1
Description
Intervention group1: received 5 mg daily from 3th of menstrual cycle for 5 days and HMG 75 u daily in 9th- 10th cycle.
Category
Treatment - Drugs
2
Description
Intervention group2: received letrozole 5 mg daily from 3th menstrual cycle for 5 days and Gonal-f (recombinant FSH) 75 u daily in 9th and 10th cycle .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Milad Infertility Clinic
Full name of responsible person
Dr.Malihe Afiat
Street address
Milad Hospital, Lashkar cross road,Taghi Abad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Sciences
Full name of responsible person
Dr. Eslami
Street address
Vice Chancellor of Mashhad University of Medical Sciences, near the Hoveizeh Cinema, Daneshgah Street, Mashhad.
City
Mashhad
Grant name
Grant code / Reference number
922121
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for 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
Vali -Asr Reproductive Health Research Center
Full name of responsible person
Mallhe Afiat
Position
Infertility Flowship
Other areas of specialty/work
Street address
First floor,Valiasr Hospital 2, Imam Khomeini Hospital, Keshavarz Blvd.
City
Tehran
Postal code
14194
Phone
+98 21 6658 1616
Fax
+98 21 6658 1658
Email
afiatm@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Reproductive Health Research Center
Full name of responsible person
Dr. Malihe Afiat
Position
Infertility Flowship
Other areas of specialty/work
Street address
First floor,Valiasr Hospital 2, Imam Khomeini Hospital, Keshavarz Blvd.
City
Tehran
Postal code
14194
Phone
+98 21 6658 1616
Fax
+98 21 6658 1658
Email
afiatm@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Vali Asr Reproductive Health Research Center
Full name of responsible person
Fedyeh Haghollahi
Position
Researcher
Other areas of specialty/work
Street address
First floor,Valiasr Hospital 2, Imam Khomeini Hospital, Keshavarz Blvd.
City
Tehran
Postal code
14194
Phone
+98 21 6658 1616
Fax
+98 21 6658 1658
Email
fedyeh_hagh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)