Protocol summary

Summary
To investigate the effects of ovulation induction using letrozole and clomiphene citrate in combination with rFSH on outcome of IUI cycles in those suffering from infertility. This was a randomized clinical trial being performed in Shiraz Ghadir hospital and our private infertility clinic, during a 24-months period. 144 women with unexplained infertility were randomly divided into two groups to receive ovarian superovulation. Group A (n=72) received 5-mg per day letrozole (Razak Drug Laboratory, Tehran, Iran) for 5 days from the 5th to the 9th day of cycle while Group B (n=72) received 100-mg per day clomiphene citrate (Razak Drug Laboratory, Tehran, Iran) for 5 days in the same period. All patients received highly purified recombinant FSH (Gonal-f, Serono, Hellas, Puregon, Greece) was injected subcutaneously in a dosage of 150 unit/day from the 8th day of the cycle until the day of hCG administration. Transvaginal sonography was performed on the day 11th of the cycle and according to the size and number of stimulated follicles, rFSH was continued till at least two dominant follicles with size of >18mm were seen. Then 10000 units of human chorionic gonadotropin (hCG) (Choriomon, IBSA, Switzerland) was injected intramuscularly, if serum E2 level was below 2000pg/ml. The endometrial thickness (ET) was measured the same day at its greatest diameter perpendicular to the midsagittal plane at the fundal region of the uterus. A single IUI was performed 36-40 hours after hCG administration. Main outcomes included pregnancy rate, pregnancy rate per cycle, abortion and endometrial thickneness.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012121810210N2
Registration date: 2013-01-18, 1391/10/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-01-18, 1391/10/29
Registrant information
Name
Afsun Zarei
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1233 2365
Email address
zareia@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2009-10-01, 1388/07/09
Expected recruitment end date
2011-10-01, 1390/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of letrozole versus clomiphene citrate in combination with recombinant follicle-stimulating-hormone in induction ovulation on intrauterine insemination outcome
Public title
Effects of letrozole versus clomiphene citrate in combination with ghonadotropins on IUI cycle in infertile couples
Purpose
Treatment
Inclusion/Exclusion criteria
We included those 18–40 years old patients who suffered from unexplained infertility, mild male factor (according to World Health Organization criteria), PCOS, cervical factors and mild endometriosis. Exclusion criteria: Cigarette smoking and alcohol abuser (both partner), ovarian hyperstimulation syndrome
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 144
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 Shiraz University of Medical Sciences
Street address
8th Floor, main building of Shiraz University of Medical Sciences, Zand Avenue
City
Shiraz
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
CT-90-5947

Health conditions studied

1

Description of health condition studied
Infertility and treatment methods
ICD-10 code
N97
ICD-10 code description
Female infertility associated with anovulation

Primary outcomes

1

Description
Pregnancy
Timepoint
two weeks after the missed period
Method of measurement
measuring level of blood BhCG by ELISA

2

Description
endometrial thickness
Timepoint
when human chorionic gonadotropin (hCG) was injected
Method of measurement
measure by transvaginal sonoghraphy at its greatest diameter perpendicular to the midsagittal plane at the fundal region of the uterus

Secondary outcomes

1

Description
clinical pregnancy rate
Timepoint
4weeks after the missed period
Method of measurement
detecting of intrauterine sac by vaginal sonography

2

Description
multiple pregnancy
Timepoint
4 weeks after the missed period
Method of measurement
detecting of intrauterine sacs by vaginal sonography

Intervention groups

1

Description
Group A patients received 5 mg/day letrozole at days 5-9 menstrual cycle before IUI (n=72). All patients received 150 IU rFSH (Gonal-f, Serono, Hellas, Puregon, Greece) from day 8 until day of hCG administration.10000 IU of hCG (Choriomon, IBSA, Switzerland) was injected when there were one or two mature follicles with diameter of more than 18 mm. A single IUI was performed 36-40 hours after hCG administration.
Category
Treatment - Drugs

2

Description
Group B received 100-mg per day clomiphene citrate (Razak Drug Laboratory, Tehran, Iran) for 5 days in at days 5-9 menstrual cycle and 150 IU rFSH from day 8 until day of hCG administration.10000 IU of hCG was injected when there were one or two mature follicles with diameter of more than 18 mm. A single IUI was performed 36-40 hours after hCG administration.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Infertility center of Ghadir hospital
Full name of responsible person
Street address
Infertility Research Center, 4th Floor, Ghadir Hospital, Ghoran Avenue
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz university of medical sciences
Full name of responsible person
Dr. Gholam Reza Hatam
Street address
Shiraz University of Medical sciences, Zand Avenue Sciences, Zand Avenue
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz university of medical sciences
Full name of responsible person
Dr. Afsun Zarei
Position
Assistant professor of OB & GYN / Obstetrician and Gynecologist
Other areas of specialty/work
Street address
OB & GYN department, Faghihi Hospital, Zand Avenue
City
Shiraz
Postal code
Phone
+98 71 1233 2365
Fax
Email
zareia@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz university of medical sciences
Full name of responsible person
Saeed Alborzi
Position
Professor of OB & GYN / Obstetrician and Gynecologist
Other areas of specialty/work
Street address
OB & GYN department, Faghihi Hospital, Zand Avenue
City
Shiraz
Postal code
Phone
+98 71 1233 2365
Fax
Email
alborzis@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Infertility Research Center
Full name of responsible person
Nasrin Dadras
Position
infertility fellowship
Other areas of specialty/work
Street address
Infertility Research Center, 4th Floor, Ghadir Hospital, Ghoran Avenue
City
Shiraz
Postal code
Phone
+98 71 1646 2610
Fax
Email
dadras.nasrin@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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