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Evaluating the Effects of Iatrogenic Endometrial Injury before Performing Intrauterine Insemination in Increasing Fertility in Couples Referred to infertility center

Protocol summary

Summary
In this study we investigated the effect of local endometrial injury on outcome on IUI cycles. This is a randomized clinical trial being performed at Shiraz Ghadir hospital and private infertility clinics during a 17–months period from January 2011 to May 2012. 144 women with unexplained, mild male factor and mild endometriosis selected for IUI cycles undergoing IUI. Patients were randomly (based on a computer random digit generator using their registration number) assigned to two groups. Group A underwent endometrial biopsy, by a Novak curret biopsy catheter (Neuilly-en-Thelle, France) between days 6–8 of previous menstrual cycle before IUI (n=72) and group B (n=72) underwent IUI cycles without undergoing endometrial biopsy. All the patients received 100-mg per day clomiphene citrate (Razak Drug Laboratory, Tehran, Iran) for 5 days from the 5th to the 9th day of cycle and highly purified recombinant FSH (Gonal-f, Serono, Hellas, Puregon, Greece) was injected intramuscularly in a dosage of 100 unit/day from the 8th day of the cycle. Then 10000 units of human chorionic gonadotropin (hCG) (Choriomon, IBSA, Switzerland) was injected intramuscularly, if at least one dominant follicles with size of >18mm were seen by transvaginal sonography and serum E2 level was below 2000pg/ml. Intrauterine insemination (IUI) was performed after 36 hours hCG injection. Main outcomes included pregnancy rate, pregnancy rate per cycle, abortion and ongoing pregnancy rates and endometrial thickneness.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012070810210N1
Registration date: 2013-01-12, 1391/10/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-01-12, 1391/10/23
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
2011-03-21, 1390/01/01
Expected recruitment end date
2012-05-21, 1391/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the Effects of Iatrogenic Endometrial Injury before Performing Intrauterine Insemination in Increasing Fertility in Couples Referred to infertility center
Public title
Evaluating the Effects of Iatrogenic Endometrial Injury before Performing Intrauterine insemination
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 18–40 years old patients who suffered from unexplained infertility, mild male factor and mild endometriosis; All women had normal plasma concentrations of day 3 LH and FSH; normal tests of renal and hepatic function; normal complete blood counts; normal HSG, laparoscopy and hysteroscopy and negative pregnancy tests. When the endometriosis was diagnosed, the stage was determined according to the revised American society for reproductive medicine classification and the score was recorded. Only those with mild endometriosis were included in the study while those with moderate to severe endometriosis were excluded from the study. Exclusion criteria: hirsutism; autoimmune disorders; endocrinopathies; cirrhosis and other chronic liver diseases; cigarette smoker and/or alcohol abuser (each of the partner); ovarian hyperstimulation syndrome (OHSS ); no desire to continue the program.
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 144
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 Shiraz University of Medical Sciences
Street address
8th Floor, main building of Shiraz University of Medical Sciences, Zand Avenue
City
Shiraz
Postal code
Iran
Approval date
2011-12-03, 1390/09/12
Ethics committee reference number
39731/04/9/پ/90/ص

Health conditions studied

1

Description of health condition studied
Infertility and treatment methods
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified

Primary outcomes

1

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

Secondary outcomes

1

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

Intervention groups

1

Description
Group A undergo endometrial biopsy, by a Novak curret biopsy catheter (Neuilly-en-Thelle, France between days 6–8 of previous menstrual cycle before IUI (n=72) and group B (n=72) underwent IUI cycles without undergoing endometrial biopsy. All the patients received 100-mg per day clomiphene citrate (Razak Drug Laboratory, Tehran, Iran) for 5 days from the 5th to the 9th day of cycle and highly purified recombinant FSH (Gonal-f, Serono, Hellas, Puregon, Greece) was injected intramuscularly in a dosage of 100 unit/day from the 8th day of the cycle. Then 10000 units of human chorionic gonadotropin (hCG) (Choriomon, IBSA, Switzerland) was injected intramuscularly, if at least one dominant follicles with size of >18mm were seen by transvaginal sonography and serum E2 level was below 2000pg/ml. Intrauterine insemination (IUI) was performed 36 hours after hCG injection .
Category
Treatment - Other

2

Description
In the control group no intervention will be done.
Category
N/A

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. Gholamreza Hatam
Street address
8th Floor, main building of Shiraz University of Medical 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
Iran
Phone
+98 71 1233 2365
Fax
Email
zareia@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Infertility Research Center
Full name of responsible person
Dr. 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
Iran
Phone
+98 71 1646 2610
Fax
Email
dadras.nasrin@gmail.com
Web page address

Person responsible for updating data

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/Infertility Fellowship
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
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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