Comparison of the efficacy &effectiveness of clomiphen citrate and recombinant FSH in infertile women candidated for IUI refering to infertility clinic of vali e asr hospital
The aim of this study was to compare the effectiveness and efficiency of Clomiphen Citrate and recombinant gonadotropin (r-FSH) in women candidated for IUI in infertility vale –asr r hospital This study is randomized clinical trial ,the efficacy &effectiveness of these drugs were compared and one of them as the first choice for induction ovulation in patients were selected. 30 infertile women with age lower than 40 years ;the first cycle of treatment;primary infertility;duration of infertility lower than 5years;normal uterine cavity and patent fallopian tubes;normal sperm analysis according to WHO criteri as mild male factor were selected .
Women with moderate to severe endometriosis diagnosed with laparascopy;history of prior abdominal or gynecological surgery;history of PID; allergy or contraindication for hormonal drug usage are excluded and will be randomized in tow groups (A&B)in group A,15 patients with daily usage of 50mg clomiphen citrate from 3rd to 7th day of menstrual cycle and in group B, 15 patients with75IU recombinant FSH from 4th day of menstrual cycle will be injected and sonographic monitoring will be done in 11th day.Primary outcomes are live birth rate,on going pregnancy rate.Secondary outcomes are abortion rate,multi gestation pregnancy rate and live births .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201211135181N8
Registration date:2015-08-15, 1394/05/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-08-15, 1394/05/24
Registrant information
Name
Batool Rashidi
Name of organization / entity
Vali E Asr Reproductive Health Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 6693 9320
Email address
bhrashidi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences.
Expected recruitment start date
2015-01-21, 1393/11/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy &effectiveness of clomiphen citrate and recombinant FSH in infertile women candidated for IUI refering to infertility clinic of vali e asr hospital
Public title
comparison of the efficacy &effectiveness of clomiphen citrate and recombinant FSH in infertile women candidated for IUI
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age lower than 40 years ; the first cycle of treatment;primary infertility; duration of infertility <5years; normal uterine cavity and patent fallopian tubes approved in HSG or laparascopy;normal sperm analysis according to WHO criterias(volume 1.5-5 ml; PH>7.2;viscosity<3;sperm concentration>20000000/ml; total sperm count>40000000;motility>50%;forward progresion>2 ; normal morphology>50% ;round cell<5000000/ml;sperm aglutination<2) mild male factor .
Exclusion criteria: moderate to severe endometriosis diagnosed with laparascopy;history of prior abdominal or gynecological surgery;history of PID; history of allergy or contraindication for hormonal drug usage .
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:
100
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
Chancellor forResearch Tehran University of Medical Sciences
Street address
Medical university, Ghods street , Keshavarz BLvd.
City
Tehran
Postal code
14194
Approval date
2015-01-21, 1393/11/01
Ethics committee reference number
9011290019
Health conditions studied
1
Description of health condition studied
female infertility
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation
Primary outcomes
1
Description
clinical pregnancy
Timepoint
6-7 weeks after IUI(intra uterine insemination)
Method of measurement
sonography and geststional sac detection
2
Description
chemical pregnancy
Timepoint
2-3 weeks after IUI
Method of measurement
labratory test
3
Description
ongoing pregnancy rate
Timepoint
20 weeks after IUI
Method of measurement
SONOGRAPHY
Secondary outcomes
1
Description
Abortion
Timepoint
20th week of pregnancy
Method of measurement
follow up the patient and do sonography
2
Description
multi gestation pregnancy
Timepoint
6-7weeks after IUI
Method of measurement
sonography and detection several gestational sacs
3
Description
live birth rate
Timepoint
36-40th week of pregnancy
Method of measurement
follow up the patient
Intervention groups
1
Description
in Interventional Group 1: with daily usage of 50 mg Clomiphen citrate oral tablet from 3rd to 7th day of menstrual cycle.
Category
Treatment - Drugs
2
Description
In intervention Group 2: Subcutaneously Daily injection of 75IU Recombinant Gonadotropine from 4th day of menstrual cycle.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Val-e-Asr Infertility Clinic
Full name of responsible person
Bahareh Khandzad
Street address
Infertility Clinic of Vali e Asr Hospital, Imam khomeini hospital, Keshavarz blvd
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chanceler for Research Tehran university of Medical Sciences
Full name of responsible person
Dr. Masoud Younesian
Street address
Tehran university of Medical Sciences, Poursina av.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chanceler for Research Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Bahareh Khandzad
Position
Obstetrics&Gynecology resident of Tehran university of Medical Sciences
Other areas of specialty/work
Street address
Infertility clinic of Vali e Asr Hospital, Imam khomeini hospital, Keshavarz Blvd.
City
Tehran
Postal code
14194
Phone
+98 21 6693 9320
Fax
+98 21 6658 1658
Email
b_khandzad@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research Center of Infertility in Vali e Asr hospital
Full name of responsible person
Dr. Batool Hossein Rashidi
Position
Professor
Other areas of specialty/work
Street address
Keshavarz Blvd, Imam Hospital Complex.
City
Tehran
Postal code
14194
Phone
+98 21 6693 9320
Fax
+98 21 6658 1658
Email
bhrashidi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Research Center ofInfertility-vali e Asr hospital
Full name of responsible person
Fedieh Haghollahi
Position
Researcher
Other areas of specialty/work
Street address
Vali e Asr Hospital-Imam khomeini Hospital, Keshavarz Blvd.
City
Tehran
Postal code
Phone
+98 21 6693 9320
Fax
+98 21 6658 1658
Email
fedyeh_hagh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)