Comparison of successful pregnancy rate after IVF between patients with hysteroscopy and endometrial biopsy and patients with hysteroscopy without biopsy during treatment cycle
The purpose of this study is comparison of successful pregnancy rate after IVF between patients with hysteroscopy and endometrial biopsy and patients with hysteroscopy without biopsy during treatment cycle. Women who are referred to the Shariati infertility center for IVF for the first time will be entered. Patients with uterine anomalies; endometriosis; uterine myoma; IVF failure and those with an azoospermic partners will be excluded. After signing an informed consent 44 patients with the same protocol at the same day of the cycle (8th day) will be allocated to one of the therapeutic groups including only hysteroscopy (22 patients) or hysteroscopy plus endometrial biopsy (22 patients). Under general anesthesia and using Claw forceps during hysteroscopy, a 2mm endometrial biopsy will be taken from the posterior surface of endometrium -1.5 cm inferior to the fondus. Procedure takes about 5 minutes.Clinical pregnancy as a primary outcome will be comparison between 2 groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015013020871N1
Registration date:2015-04-13, 1394/01/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-04-13, 1394/01/24
Registrant information
Name
Aida Najafian
Name of organization / entity
Tehran Univercity of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8822 0050
Email address
anajafian@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2015-06-21, 1394/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of successful pregnancy rate after IVF between patients with hysteroscopy and endometrial biopsy and patients with hysteroscopy without biopsy during treatment cycle
Public title
Effect of hysteroscopy on increase of pregnancy rate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women who are referred for IVF for the first time; age:18-35 years
Exclusion criteria: previous history of IVF failure; uterine anomaly; endometriosis ; uterine myoma; those whose partner has azospermia.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Science
Street address
Keshavarz Bulvar-Ghods Street
City
Tehran
Postal code
Approval date
2015-01-21, 1393/11/01
Ethics committee reference number
9211400003-135977
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
female infertilty
Primary outcomes
1
Description
Clinical Pregnancy
Timepoint
5 weeks after intervention
Method of measurement
Gestational Sac and Fetal Heart Rate
Secondary outcomes
1
Description
Chemical Pregnancy
Timepoint
3 weeks after intervention
Method of measurement
Serum BhCG level
2
Description
Implantation Rate
Timepoint
5 weeks after intervention
Method of measurement
Number of gestational sac divided by the number of embryos transfer
Intervention groups
1
Description
In the control group after general anesthesia with mask under hysteroscopic guid we irrigate uterine cavity.
Category
Treatment - Surgery
2
Description
In the intervention group after general anesthesia with mask under hysteroscopic guid with claw forceps we take a 2 mm biopsy 1.5 cm below the fondus.Time of surgery is about 5 minutes.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility Center of Shariati Hospital
Full name of responsible person
Dr.Aida Najafian-Infertility Fellowship
Street address
North Kargar-Serahe Jamaledin Asad Abadi
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Reasearch Center of Tehran University of Medical Science- Shariati Hospital
Full name of responsible person
Dr Yoonesi
Street address
Ghods street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Reasearch Center of Tehran University of Medical Science- Shariati Hospital
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 Science- Shariati Hospital