Comparison of pregnancy rate in single versus double Intrauterine Insemination (IUI) when polycystic ovarian syndrome or unexplained, mild male factor infertility is present.
The aim of this study is to compare of pregnancy rate of single intrauterine insemination (IUI) compared to double intrauterine insemination (IUI) when conditions of unexplained, mild male factor infertility or polycystic ovarian syndrome exist. This prospective and randomized clinical trial will be conducted on females who have engaged in sexual intercourse over a period of one year without contraceptives but failed to become pregnant and were referred to a private infertility center.
A review of the medical history, verification of ovulation using progesterone serum level in the middle of the loteual phase, for confirming of opening of fallopian tubes using laprascopy or histrosalpangography and anatomical study of uterus using ultrasonography will be performed on each female candidate. Hormonal assessing will be performed on the 3th day of menstrual cycle.
Semen analysis will be performed on the male partner of each candidate.
Induction of ovulation will be performed using (1) oral tablet, (2) injection of HMG and HCG or (3) both methods, based on the opinion of the physician.
Candidates will enter into the study upon administering the first dose of HCG.
Vaginal sonography will be performed on the 3rd day following induction of ovulation. Any female with an ovarian cyst greater than 15mm in diameter will exclude from the study.
Subjects will be divided into single step or double step intrauterine insemination groups by block randomization.
Single step IUI will be performed 36 hours after receiving HCG and double step IUI will be performed 18 hours and 40 hours after receiving HCG.
Pregnancy Test (serum BHCG level) will be performed 14 days after IUI. Visual inspection of the Fetal Heart Rate (FHR) using transvaginal sonography will be performed at the 7th week.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201307231306N7
Registration date:2013-08-03, 1392/05/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-08-03, 1392/05/12
Registrant information
Name
Ziba Zahiri
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 5624
Email address
drzibazahiri@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Guilan University of Medical Sciences
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2014-06-22, 1393/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of pregnancy rate in single versus double Intrauterine Insemination (IUI) when polycystic ovarian syndrome or unexplained, mild male factor infertility is present.
Public title
Comparison of pregnancy rate in single versus double Intrauterine Insemination (IUI) when polycystic ovarian syndrome or unexplained, mild male factor infertility is present.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: base serum level of FSH<12 mIu/l; females with polycystic ovarian syndrome who have not become pregnant despite six times of ovulation induction and having a suitable ovum.Females whose male partners have unexplained, mild male factor infertility; have no severe medical illness; no obstruction in tubes; no uterine anomaly.
Exclusion criteria: existence of less than 2 or more than 5 ovarian follicles; any severe medical illness; females with ovarian cysts greater than 15mm after 3rd day following menstruation (diagnosed using transvaginal sonography).
Age
From 35 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
580
Randomization (investigator's opinion)
Randomized
Randomization description
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
Ethics Committee of Guilan University of Medical Sciences
Street address
Ethics Committee Guilan University of Medical Sciences. Gaz Square
City
Rasht
Postal code
Approval date
2013-06-17, 1392/03/27
Ethics committee reference number
1920101206
Health conditions studied
1
Description of health condition studied
Ovarian dysfunction
ICD-10 code
E28
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Pregnancy
Timepoint
14 days after IUI
Method of measurement
Serum BHCG level assessment
Secondary outcomes
1
Description
Pregnancy outcome
Timepoint
14 days after IUI
Method of measurement
Serum BHCG level assessment
2
Description
Diagnosis of intrauterine pregnancy
Timepoint
7th week of pregnancy
Method of measurement
Fetal Heart Rate (FHR) (transvaginal sonography)
3
Description
Frequency of complications (abortion, ectopic pregnancy, multifetal gestation)
Timepoint
Completion of treatment and follow up period
Method of measurement
Diagnosis of ectopic pregnancy and
Intervention groups
1
Description
Ovulation induction using
(1) tablets containing clomiphene citrate and letrozole,
(2) injections including HMG and HCG
or
(3) both tablets and injection
followed by single step IUI at 36 hours after tablet/injection/both
Category
Treatment - Devices
2
Description
Ovulation induction using:
(1) tablets containing clomiphene citrate and letrozole,
(2) injections including HMG and HCG
or
(3) both tablets and injection
followed by double step IUI at 18 hours and 40 hours after tablet/injection/both
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran
Full name of responsible person
Ziba Zahiri
Street address
Alzahra Hospital, Namjo Street
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Guilan University of Medical Sciences
Full name of responsible person
Abdolrasol Sobhani
Street address
Vice Chancellor for Research Guilan University of Medical Sciences. Gaz Square
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Romina Rashid Shomali
Position
obstetrics & Gynecology Resident of Medical Sciences
Other areas of specialty/work
Street address
Reproductive Health Research Center, Alzahra Hospital, Namjo Street
City
Rasht
Postal code
Phone
+98 13 1322 5624
Fax
Email
Rominashomali@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Ziba Zahiri
Position
Associated Professor Guilan University of Medical Sciences
Other areas of specialty/work
Street address
Reproductive Health Research Center, Alzahra Hospital, Namjo Street
City
Rasht
Postal code
Phone
+98 13 1322 5624
Fax
Email
drzibazahiri@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Nazli Peiravian
Position
B.S of Nursing
Other areas of specialty/work
Street address
Reproductive Health Research Center, Alzahra Hospital, Namjo Street,
City
Rasht
Postal code
Phone
+98 13 1322 5624
Fax
Email
h_fertility@gums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)