Evaluation of the efficiency of clomiphene citrate plus letrozole gonadotropins for superovulation in patients undergoing intrauterine insemination: a randomized trial
The aim of present study is to evaluate the efficiency of clomiphene citrate plus letrozole gonadotropins for in patients undergoing superovulation for Intrauterine Insemination (IUI).
Design
A randomized, non-blinded clinical trial with a parallel group design of 501 patients
Settings and conduct
This study is a non-blind randomized clinical trial and will be carried out on patients who will refer to Mehr medical institute and Al-Zahra hospital Rasht, Iran for infertility treatments.
Participants/Inclusion and exclusion criteria
IUI candidates, Inclusion criteria: Age ≤ 38 years, Basal FSH level <10, Patients without history of allergic reactions to clomiphene, Mild male factor infertility, Unexplained infertility, Anovolatory patients who have not been pregnant despite the use of ovulation induction techniques and appropriate follicles. Exclusion criteria: No response to ovulation induction, Patients with large number of follicles who cannot receive hCG
Intervention groups
Group A will receive clomiphene citrate (100 mg) on cycle day 3-7 (for 5 days).
Group B will receive Letrozole (5 mg) on cycle day 3-7 (for 5 days).
Group C will receive clomiphene citrate (50mg) plus Letrozole (2.5 mg) on cycle day 3-7 (for 5 days).
Main outcome variables
Clinical pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180528039878N1
Registration date:2018-07-19, 1397/04/28
Registration timing:prospective
Last update:2018-07-19, 1397/04/28
Update count:0
Registration date
2018-07-19, 1397/04/28
Registrant information
Name
Marzieh Mehrafza
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3376 4270
Email address
dr.Mehrafza@mehrinstitute.org
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficiency of clomiphene citrate plus letrozole gonadotropins for superovulation in patients undergoing intrauterine insemination: a randomized trial
Public title
Evaluation of the efficiency of clomiphene citrate plus letrozole on intrauterine insemination outcome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age ≤ 38 years•
Basal FSH level <10
Patients without history of allergic reactions to clomiphene
Mild male factor infertility
Unexplained infertility
Anovolatory patients who have not been pregnant despite the use of ovulation induction techniques and appropriate follicles
Exclusion criteria:
No response to ovulation induction
Patients with large number of follicles who cannot receive hCG
Age
To 38 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
501
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization will be used to allocate participants into the three groups (with allocation ratio of 1:1:1).
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
ٍEthical committee of Guilan university of medical sciences
Street address
Mehr Fertility Research Center, Mehr Medical Institute, Ershad St., Shahid Ansari Blvd., Rasht, Iran.
City
Rasht
Province
Guilan
Postal code
417861311
Approval date
2018-07-07, 1397/04/16
Ethics committee reference number
IR.GUMS.REC.1397.146
Health conditions studied
1
Description of health condition studied
Female infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Clinical pregnancy
Timepoint
Seven weeks after intrauterine insemination
Method of measurement
Observation of gestational sac on transvaginal ultrasound
Secondary outcomes
1
Description
Number of follicles ≥ 18 mm
Timepoint
On hCG administration day
Method of measurement
By transvaginal ultrasound
2
Description
Follicular size on hCG day
Timepoint
On hCG administration day
Method of measurement
By transvaginal ultrasound
3
Description
Duration of ovarian stimulation
Timepoint
At the end of ovarian stimulation
Method of measurement
Number of days
4
Description
Endometrial thickness on hCG administration day
Timepoint
On hCG administration day
Method of measurement
By transvaginal ultrasound
5
Description
Gonadotropin dosage
Timepoint
At the end of ovarian stimulation
Method of measurement
International Units
Intervention groups
1
Description
Intervention group: Group A will receive clomiphene citrate (100 mg, Iran Hormone) on cycle day 3-7 ( for 5 days)
Category
Treatment - Drugs
2
Description
Intervention group: Group B will receive Letrozole (5 mg, SOHA, Iran) on cycle day 3-7 (for 5 days)
Category
Treatment - Drugs
3
Description
Intervention group: Group C will receive clomiphene citrate (100 mg, Iran Hormone) and Letrozole (5 mg, SOHA, Iran) on cycle day 3-7 (for 5 days)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mehr Medical institute
Full name of responsible person
Marzieh Mehrafza
Street address
Mehr Fertility Research Center, Mehr Medical Institute, Ershad St., Shahid Ansari Blvd., Rasht, Iran.
City
Rasht
Province
Guilan
Postal code
4178613111
Phone
+98 13 3376 4270
Email
marzieh.mehrafza@gmail.com
Web page address
http://www.mehrinstitute.org
2
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Marzieh Mehrafza
Street address
Reproductive Health Research Center, Alzahra Hospital, Namjoo street, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
4144654839
Phone
+98 13 3336 9224
Email
marzieh.mehrafza@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mehr medical institute
Full name of responsible person
Marzieh Mehafza
Street address
Mehr Fertility Research Center, Mehr Medical Institute, Ershad St., Shahid Ansari Blvd., Rasht, Iran.
City
Rasht
Province
Guilan
Postal code
4178613111
Phone
+98 13 3376 4270
Email
marzieh.mehrafza@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mehr medical institute
Proportion provided by this source
70
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
2
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Shadman Nemati
Street address
Research vice-chancellorship Building, in front of 17-Shahrivar Hospital, ShahidSiadati St., Namjoo Ave., Rasht, Guilan, IRAN
City
Rasht
Province
Guilan
Postal code
6694941446
Phone
+98 13 3333 5820
Email
research@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht University of Medical Sciences
Proportion provided by this source
30
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mehr medical institute
Full name of responsible person
Marzieh Mehrafza
Position
Non-academic M.D
Latest degree
Subspecialist
Other areas of specialty/work
Reproductive Biology
Street address
Mehr Fertility Research Center, Mehr Medical Institute, Ershad St., Shahid Ansari Blvd., Rasht, Iran
City
Rasht
Province
Guilan
Postal code
4178613111
Phone
+98 13 3376 4270
Email
marzieh.mehrafza@gmail.com
Web page address
http://www.mehrinstitute.org/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mehr medical institute
Full name of responsible person
Marzieh Mehrafza
Position
Non-academic M.D
Latest degree
Subspecialist
Other areas of specialty/work
Reproductive Biology
Street address
Mehr Fertility Research Center, Mehr Medical Institute, Ershad St., Shahid Ansari Blvd., Rasht, Iran
City
Rasht
Province
Guilan
Postal code
4178613111
Phone
+98 13 3376 4270
Email
marzieh.mehrafza@gmail.com
Web page address
http://www.mehrinstitute.org/
Person responsible for updating data
Contact
Name of organization / entity
Mehr medical institute
Full name of responsible person
Marzieh Mehrafza
Position
Non-academic M.D
Latest degree
Subspecialist
Other areas of specialty/work
Reproductive Biology
Street address
Mehr Fertility Research Center, Mehr Medical Institute, Ershad St., Shahid Ansari Blvd., Rasht, Iran.
City
Rasht
Province
Guilan
Postal code
4178613111
Phone
+98 13 3376 4270
Email
marzieh.mehrafza@gmail.com
Web page address
http://www.mehrinstitute.org/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is still no planning to share and publish
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The study protocol and report will be available on completion of the trial.
When the data will become available and for how long
The beginning of the access period is 6 months after the publication of the study results.
To whom data/document is available
All people interested in this field of study
Under which criteria data/document could be used
Without any limitation
From where data/document is obtainable
az.raoufi@gmail.com
What processes are involved for a request to access data/document