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The effect of administrating hyoscine before embryo transfer in ART cycles on pregnancy rate

Protocol summary

Summary
This study was a clinical trial on 142 infertile women referring to Infertility Hospital, Imam Khomeini, Ahwaz, Iran. These are women who, according to some experts due to male factor infertility, tubal, ovulatory dysfunction are candidates for ART cycles. In all patients, serum FSH levels below 10 IU / L are. Oocytes harvested 38-36 h after HCG administration can be done. HCG is administered when a follicle at least 18 mm be identified. After the formation of micro injection & embryos formation based on statistical methods for each group of patients are selected. Participants were randomly divided into two groups (Random numbers table is used for this purpose). After the embryo transfer the lower abdomen pain are questioned. Using a visual analogue scale determine and record pain. Patient information including age, duration and cause of infertility, history of ART Endometrial thickness, oocyte numbers, and the transferred embryos, embryos grade, type and number of drugs, agonist or antagonist regimen, type of catheter, and Presence or absence of cramping after embryo transfer recorded data is then analyzed by statistical tests are placed.

General information

Acronym
Hyoscin
IRCT registration information
IRCT registration number: IRCT2012101711146N1
Registration date: 2012-12-06, 1391/09/16
Registration timing: prospective

Last update:
Update count: 0
Registration date
2012-12-06, 1391/09/16
Registrant information
Name
Shiva Kajbaf
Name of organization / entity
Jundishapour Ahwaz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1337 9098
Email address
kajbaf.sh@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahwaz Jundishapour University of Medical Science.Vice Chancellor for Research
Expected recruitment start date
2012-12-21, 1391/10/01
Expected recruitment end date
2013-03-05, 1391/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of administrating hyoscine before embryo transfer in ART cycles on pregnancy rate
Public title
The effect of hyoscine on pregnancy rate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: The women who are nominated to ART cycle. Exclusion criterion:contraindication for Hyoscin Bromide.
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 142
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
Ahwaz Jundiahapour University Of Medical Science
Street address
Ahwaz.bulvar of golestan.Juhdishapor University Of Medical Science
City
Ahwaz
Postal code
61257-15794
Approval date
2012-04-07, 1391/01/19
Ethics committee reference number
eth-410

Health conditions studied

1

Description of health condition studied
Infertility
ICD-10 code
N46-N97
ICD-10 code description
-Male infertility-Female infertility

Primary outcomes

1

Description
Pain Ratio
Timepoint
One Hour After Embryo Transfer
Method of measurement
Visual Analogue Scale

Secondary outcomes

1

Description
Pregnancy Ratio
Timepoint
16 Days After Embryo Transfer
Method of measurement
B-HCG TEST

Intervention groups

1

Description
Intervention group: hyoscin injected 30 minute before embryo transfer
Category
Treatment - Drugs

2

Description
Control group: embryo transfer is performed without hyoscin injection
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Hospital. Research & Infertility Ward
Full name of responsible person
Shiva Kajbaf
Street address
Ahwaz.Emam HospitalL
City
Ahwaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahwaz Jundishapour University of Medical Sciences
Full name of responsible person
Mostafa Feghhi MD
Street address
Ahwaz. Bulvar of Golestan Jundishapour University of Medical Sciences
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahwaz Jundishapour 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
Ahwaz Jundishapour University of Medical Sciences
Full name of responsible person
Shiva Kajbaf
Position
Gynecology & Obstetric Resident
Other areas of specialty/work
Street address
Ahwaz. Emam Hospital
City
Ahwaz
Postal code
6193673166
Phone
+98 61 1337 9098
Fax
Email
kajbaf.shiva@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahwaz Jundishapor University of Medical Sciences
Full name of responsible person
Mahvash Zargar MD
Position
Obstetetric &Gynecologist. Fellowship of Iinfertility
Other areas of specialty/work
Street address
Ahwaz.Emam Hospital
City
Ahwaz
Postal code
61933673166
Phone
+98 61 1222 7410
Fax
Email
Dr.zargar@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahwaz.Jundishapour University of Medical Sciences
Full name of responsible person
Shiva Kajbaf
Position
Obstetric & Gynecology Resident
Other areas of specialty/work
Street address
Ahwaz.Emam Hospital
City
Ahwaz
Postal code
6193673166
Phone
+98 611227410
Fax
Email
kajbaf.shiva@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
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