Aim and background: 10 to 15% of couples in reproductive age is infertile; controlled ovarian stimulation and intrauterine insemination (COS+IUI) is a common therapeutic procedure among infertile couples (unexplained and male factor infertility).Despite the differences in gonadotropin type, content and activity and their widespread use, few studies compared these products. In this study we compare two COS regimens, Clomiphen Citrate + HMG(Human menopausal gonadotropin) and Clomiphen Citrate + rFSH(recombinant follicule stimulating hormon).Material and methods : This is a Randomized Clinical Trial with 82 Cycles in CC + HMG and 60 cycles in CC + rFSH group.Patients with mild male factor and unexplained infertility were randomized to receive CC+ HMG or CC + rFSH.COS was started on 3rd day after menstruation after the basal transvaginal ultrasonography(TV_USG) with 100 mg CC for 5 consecutive day and gonadotropin administration began on 7th day with 75 IU.(if ≥35 years old 150 IU was given)The cycles was monitored by TV_USG from the 9th day and then every other day. On the day that 1 or more follicles of≥16mm were sewen,10'000 IU HCG was administerd and 36 hours later IUI was performed.14 days after IUI βHCG level was checked.In case of pregnancy a TV_USG was performed at 7th week of gestation to confirm clinical pregnancy,all pregnancies were followed up to 12 weeks of gestation. .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201109163386N4
Registration date:2011-10-01, 1390/07/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-10-01, 1390/07/09
Registrant information
Name
Azam Azargoon
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 1446 3401
Email address
a-azargoon@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2009-06-18, 1388/03/28
Expected recruitment end date
2010-06-20, 1389/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of controlled ovarian stimulation with clomiphen citrate HMG(Human menopausal gonadotropin) or clomiphen citrate rFSH(recombinant follicule stimulating hormon) in IUI(Intrauterine Insemination)cycles.
Public title
Comparison of controlled ovarian stimulation with clomiphen citrate HMG(Human menopausal gonadotropin) or clomiphen citrate rFSH(recombinant follicule stimulating hormon) in IUI(Intrauterine Insemination) cycles.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: history of infertility of more than 1 year; wemon's age between 20 and 40 years old; documentation of normal ovulatory cycles; normal TSH and Prolactin level; normal reproductive hormones in the early follicular phase;patent tubes have been shown by HSG or laparoscopy; normal sperm count, motility and morphology according to the World Health Organization criteria(WHO 1992)in unexplained infertility and total motile sperm count more than 1 million in male factor infertility.
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
142
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
Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij-blvd
City
Semnan
Postal code
Approval date
2009-06-17, 1388/03/27
Ethics committee reference number
آ/2/3788
Health conditions studied
1
Description of health condition studied
Unexplained infertility
ICD-10 code
n97.9
ICD-10 code description
Female infertility, unspecified
2
Description of health condition studied
Male factor infertility
ICD-10 code
n46
ICD-10 code description
Oligospermia NOS
Primary outcomes
1
Description
Clinical pregnancy rate
Timepoint
7 weeks of gestation
Method of measurement
Fetal heart activity with ultrasound
2
Description
Ongoing pregnancy rate
Timepoint
12 weeks of gestation
Method of measurement
Fetal heart activity with ultrasound
Secondary outcomes
1
Description
Mean of follicular size on the day of HCG administration
Timepoint
Day of occurrence of at least one ovarian follicule ≥16 mm in diameter
Method of measurement
Ultrasound
2
Description
Endometrial thickness on the day of HCG administration
Timepoint
Day of occurrence of at least one ovarian follicule ≥16 mm in diameter
Method of measurement
Ultrasound
3
Description
Total dose of gonadotropin
Timepoint
Day of occurrence of at least one ovarian follicule ≥16 mm in diameter
Method of measurement
Number of vials
4
Description
Duration of stimulation with gonadotropin
Timepoint
Day of occurrence of at least one ovarian follicule ≥16 mm in diameter
Method of measurement
Number of days gonadotropin was administered
5
Description
Number of dominant follicles on the day of HCG administration
Timepoint
Day of occurrence of at least one ovarian follicule ≥16 mm in diameter
Method of measurement
Number of dominant follicles
Intervention groups
1
Description
Ovarian cycle stimulation was started on the 3rd day of menstruation after the basal transvaginal ultrasound (TV-USG) with 100 mg CC for 5 consecutive days.The gonadotropin regimens adopted in each group was HMG 75 IU (Merional HP,Serono,Turkey ) ,intramuscular,daily from day 7 of menstrual cycle.(If older than 35 years old 150 IU was given).
TV-USG was started from day 9 of menstrual cycle every other day for follicular size tracing.The gonadotropin dose was continued until the occurrence of at least one ovarian follicule ≥16 mm in diameter,then HCG (Profasi,Serono,Turkey) 10'000 IU was administered intramuscularly to trigger final follicular maturation and IUI with a sperm swim-up procedure was performed 35-36 hours later with Wallace Artificial Insemination Catheter(UK) SMITHS .For prevention of OHSS ovulation was induced by 0.5 cc GnRH-a (superfact….) if there were ≥5 follicles with a diameter of ≥ 16 mm at the time of induction.
The luteal phase was supported with 400 mg of vaginal progesterone suppository (Cyclogest,Actavis,UK)twice a day administered from the day of IUI for two weeks.A blood sample for βHCG (beta human chorionic gonadotropin) were obtained two weeks after IUI for pregnancy confirmation.A clinical pregnancy was determined by the visualization of an embryo with cardiac activity at 7 weeks of gestation in TV-USG.In case of pregnancy progesterone was continued till 12 weeks of gestation.
Category
Treatment - Drugs
2
Description
Ovarian cycle stimulation was started on the 3rd day of menstruation after the basal transvaginal ultrasound (TV-USG) with 100 mg CC for 5 consecutive days.The gonadotropin regimens adopted was rFSH 75 IU (Gonal F,Serono,Turkey),subcutaneous from day 7 of menstrual cycle.(If older than 35 years old 150 IU was given)
TV-USG was started from day 9 of menstrual cycle every other day for follicular size tracing.The gonadotropin dose was continued until the occurrence of at least one ovarian follicule ≥16 mm in diameter,then HCG (Profasi,Serono,Turkey) 10'000 IU was administered intramuscularly to trigger final follicular maturation and IUI with a sperm swim-up procedure was performed 35-36 hours later with Wallace Artificial Insemination Catheter(UK) SMITHS.For prevention of OHSS ovulation was induced by 0.5 cc GnRH-a (superfact….) if there were ≥5 follicles with a diameter of ≥ 16 mm at the time of induction.
The luteal phase was supported with 400 mg of vaginal progesterone suppository (Cyclogest,Actavis,UK)twice a day administered from the day of IUI for two weeks.A blood sample for βHCG (beta human chorionic gonadotropin) were obtained two weeks after IUI for pregnancy confirmation.A clinical pregnancy was determined by the visualization of an embryo with cardiac activity at 7 weeks of gestation in TV-USG.In case of pregnancy progesterone was continued till 12 weeks of gestation
.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Al Momenin Hospital
Full name of responsible person
Street address
Imam Hosein Square
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Research deputy
Street address
Semnan University of Medical Sciences, Basij-blvd
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Marjan Bahrami
Position
Gynecolgy Resident
Other areas of specialty/work
Street address
Amir al momenin Hospital
City
Semnan
Postal code
3519734731
Phone
+98 23 1446 0088
Fax
+98 23 1446 1580
Email
bahrami.marjan@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Azam Azargoon
Position
Associated professor, Fellowship of infertility
Other areas of specialty/work
Street address
Amir al momenin Hospital
City
Semnan
Postal code
3519734731
Phone
+98 23 1446 0088
Fax
+98 23 1446 1580
Email
a-azargoon@sem-ums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Jafar Alavi Toousy MD
Position
Pathologist and Analyst
Other areas of specialty/work
Street address
Fatemie Hospital, Pathology Depatment
City
Semnan
Postal code
3518794431
Phone
+98 23 1332 8017
Fax
+98 23 1333 4610
Email
dr.toussy@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)