Aim: This study was performed with aim to evaluate Clomiphen citrate versus letrozole with gonadotropins in intrauterine insemination cycles.
Inclusion criteria: infertility and resistance to 3 cycle clomiphene therapy and candidate for intrauterine insemination.
Exclusion criteria: women who didn't have consent for participation.
Study population: the patients referred to Montaserieh Hospital for treatment of infertility.
Sample size: 180 cases were selected.
Intervention and its time: The first group received 5 mg/day letrozole on day 3-7 of menstrual cycle. The second group received 100 mg/day clomiphene in the same way as letrozole; in both groups, Human Menopausal Gonadotropin (hMG) was administered every day starting on day 6 to 8. Ovulation was triggered with urinary human chorionic gonadotropin (hCG) (5000 IU) when have two follicles of ≥16 mm. Intrauterine insemination was performed 36 hours later.
Primary outcomes: Follicles size and endometrial thickness.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015062422900N1
Registration date:2016-04-22, 1395/02/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-22, 1395/02/03
Registrant information
Name
Tooran Makhdoumi
Name of organization / entity
Ghaem hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 2477
Email address
ayatis@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2012-06-20, 1391/03/31
Expected recruitment end date
2013-06-20, 1392/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clomiphen citrate versus letrozole with gonadotropins in intrauterine insemination cycles: A prospective randomized trial
Public title
The effects of clomiphen citrate versus letrozole in treatment of infertility
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: infertility; resistance to 3 cycle clomiphene therapy; candidate for IUI
Exclusion criteria: no consent for participation
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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
Mashhad University of Medical Sciences, Azadi Square, Mashhad, Khorasan Razavi,
City
Mashhad
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
87437
Health conditions studied
1
Description of health condition studied
Ovulation induction
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation
Primary outcomes
1
Description
follicles size
Timepoint
the days 3, 9, 12 of the cycle
Method of measurement
Transvaginal ultrasonography
2
Description
Endometrial thickness
Timepoint
after clomiphene + HMG and letrozole + HMG
Method of measurement
By transvaginal ultrasonography
Secondary outcomes
1
Description
fertility rate
Timepoint
2 weeks after IUI
Method of measurement
by positive hCG
2
Description
fertility rate
Timepoint
2 weeks after IUI
Method of measurement
by positive hCG
Intervention groups
1
Description
In the letrozole group, letrozole 2.5 mg BID was given for 5 days from day 3 of their menstrual cycle. In addition, all the patients received a daily intramuscular HMG. The dosage was 75 IU starting on day 6 of menstrual cycle until hCG administration.
Category
Treatment - Drugs
2
Description
The patients in the clomiphene + HMG group received clomiphene citrate 50 mg twice a day (BID) for 5 days starting from day 3 of their menstrual cycle. In addition, all the patients received a daily intramuscular HMG. The dosage was 75 IU starting on day 6 of menstrual cycle until hCG administration.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Montaserieh Infertility Research Center
Full name of responsible person
Tooran Makhdoumi
Street address
Montaserieh Infertility Research Center, Montaserieh Hospital, Akhonde Khorasani Street, Mashhad, Khorasan Razavi
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Faculty of Mashhad University of Medical Sciences
Full name of responsible person
Mahin Naghinia
Street address
KHorasan Razavi, Mashhad, Azadi Square, Mashhad University of Medical Sciences
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Faculty of 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
Ghaem Hospital
Full name of responsible person
Tooran Makhdoumi
Position
Researcher
Other areas of specialty/work
Street address
Ghaem Hospital, Ahmad Street, Mashhad, Khorasan Razavi
City
Mashhad
Postal code
Phone
+98 518412477
Fax
Email
makhdoumit@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghaem Hospital
Full name of responsible person
Leila Pourali
Position
Assistant Professor
Other areas of specialty/work
Street address
Ghaem Hospital, Ahmad Street, Mashhad, Khorasan Razavi
City
Mashhad
Postal code
Phone
+98 518430569
Fax
Email
pouralil@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ghaem Hospital
Full name of responsible person
Alieh Basiri
Position
Medical Student
Other areas of specialty/work
Street address
Ghaem Hospital, Ahmad Street, Mashhad, Khorasan Razavi
City
Mashhad
Postal code
Phone
+98 51 3841 2477
Fax
+98 51 3843 0569
Email
basiria901@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)