1. Home
  2. Approved trials
  3. » فارسی

To compare the effect of endometrial local injury on frequency of pregnancy in couples with unexplained infertility by control group

Protocol summary

Summary
We will study the effect of induced endometrial local injury on endometrial receptivity and embryo implantation in unexplained infertile couples. This is a randomized clinical trial which will be conducted in Shiraz, Iran. Random selection to intervention and control group was performed by drawing a piece of paper from the bag containing equal number of folded printed paper for each group. Therefore, 234 unexplained infertile women are divided into two groups. Other inclusion criteria for female are aged 23 to 35 years old, body mass index between 18 and 25 (kg/m2), anti-mullerian hormone more than1 micro gram/Liter, follicle stimulating hormone levels less than 10 milli-International Unit/milli-liter on the third day of cycle, at least 10-12 follicles in AFC count and couples receiving no drugs for infertility at least for three previous months. Those (Each of the partner) who were cigarette smoker, and/or alcohol abuser will be excluded. All the patients will undergo optimal superovulation by clomiphene-citrate (Razac Drug Laboratory, Tehran, Iran) orally administered 100 milligram/day from day 3 to day 7 of the cycle and HMG-Merional (IBSA , Lugarno , Switzerland) intramuscularly administered 75 International Unit/day from the 6th to the 8th day. Endometrial local injury was performed in the posterior wall of the uterus by pipelle endometrial sampling(Pipelle de Cornier,Prodimed, Neuilly-en-Thelle, France) during pre-ovulatory days (the day of detecting urinary lutenizing hormone (LH)-surge) just in the case group. Then all the patients in both groups were instructed to follow a regularly timed intercourse. The pregnancy (positive blood Beta human chorionic gonadotropin test by ELISA) and clinical pregnancy (detection of intrauterine sac by vaginal sonography) will be compared in the two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012082510657N1
Registration date: 2012-11-26, 1391/09/06
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-11-26, 1391/09/06
Registrant information
Name
Najmeh Maharlouei
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3230 2799
Email address
maharluei@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences, Infertility Research Center
Expected recruitment start date
2010-01-01, 1388/10/11
Expected recruitment end date
2012-03-01, 1390/12/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To compare the effect of endometrial local injury on frequency of pregnancy in couples with unexplained infertility by control group
Public title
Effectiveness of uterine local injury in improving pregnancy in unexplained infertility
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1) Couples with no obvious reasons for infertility(normal routine infertility evaluation evaluation of infertility are normal) referring to Infertility Research Center in Shiraz, Iran were included in this study. 2) infertile women who were in their 23-35 years of age, 3) body mass index between 18 and 25 (kg/m2), 4)anti-mullerian hormone more than 1 µg/l ,5) follicle stimulating hormone levels less than 10 mIU/ml on the third day of cycle, 6) at least 10-12 follicles in AFC count and 7) couples receiving no drugs for infertility at least for three previous months . The exclusion criteria were 1) women younger than 23 or older than 35, as well as those (each of the infertile partner) who were cigarette smoker, and/or alcohol abuser.
Age
From 23 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 234
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
713451978
Approval date
2012-10-02, 1391/07/11
Ethics committee reference number
CT-91-4816

Health conditions studied

1

Description of health condition studied
Infertility
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 Beta human chorionic gonadotropin 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
All the patients will undergo optimal superovulation by clomiphene-citrate (Razac Drug Laboratory,Tehran,Iran ) orally administered 100 milligram/day from day 3 to day 7 of the cycle and HMG-Merional (IBSA , Lugarno , Switzerland) intramuscularly administered 75 International Unit/day from the 6th to the 8th day. just in the case group mild endometrial local injury was performed in the posterior fundal wall of the uterus by standard piplle endometrial sampling (Pipelle de Cornier, Prodimed, Neuilly-en-Thelle, France) during the preovulatory days (the day of detecting urinary lutenizing hormone (LH)-surge) . Then all the patients in both groups were instructed to follow a regularly timed intercourse.
Category
Treatment - Other

2

Description
In the control group no intervention will be done.
Category
Treatment - Drugs

Recruitment centers

1

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

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research; Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Ebrahim Parsanezhad
Street address
Infertility Research Center, 4th Floor, Ghadir Hospital, Ghoran Avenue
City
Shiraz
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; 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
Health Policy Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
Full name of responsible person
Najmeh Maharlouei
Position
Assistant Professor
Other areas of specialty/work
Street address
Building No. 2, 8th Floor, Medical School, Zand Avenue, Shiraz, Iran Tel/Fax: +98-711-2309615
City
Shiraz
Postal code
Phone
+98 71 1230 2799
Fax
Email
najmeh.maharlouei@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Infertility Research Center
Full name of responsible person
Nasrin Dadras
Position
under training of 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

Person responsible for updating data

Contact
Name of organization / entity
Infertility Research Center
Full name of responsible person
Nasrin Dadras
Position
fellowship of infertility
Other areas of specialty/work
Street address
IVF Center, Fourth Floor, Ghadir Hospital, Ghoran Avenue, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 1227 9705
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
Loading...