Protocol summary

Summary
One of the most important steps in ART is embryo transfer. Cervical mucus can influence on implantation. Transfer technique is as effective as embryo quality. Also cervical mucus aspiration may induce better implantation but cervical irritation within aspiration can increase uterine contractions and decrease implantation. The aim of this study is evaluation of mucus aspiration on implantation rate and clinical pregnancy. Method: In a clinical trial 120 infertile women with male factor infertility were divided into two groups randomly. In one group, before embryo transfer cervical mucus aspiration were done by Mucat catheter. Pregnancy rate was determined with βhCG titer 12 days after transfer and compared between two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201201168750N1
Registration date: 2012-09-17, 1391/06/27
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-09-17, 1391/06/27
Registrant information
Name
Roya Kabodmehri
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 7082
Email address
r.kabodmehri@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Hamedan University of Medical Sciences
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2012-08-22, 1391/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of cervical mucus aspiration on clinical pregnancy rate before embryo transfer
Public title
Effect of cervical mucus aspiration on clinical pregnancy rate before embryo transfer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Infertile women with male factor Infertility. Exclusion criteria: Infertile women with women factor infertility.
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: 120
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
Hamedan university of medical sciences
Street address
Hamedan university of medical sciences, Shahid Fahmide Blvd
City
Hamedan
Postal code
Approval date
2011-10-03, 1390/07/11
Ethics committee reference number
2659/9/35/16/پ/د

Health conditions studied

1

Description of health condition studied
Male factor infertility
ICD-10 code
N46
ICD-10 code description
Azoospermia NOS Oligospermia NOS

Primary outcomes

1

Description
Clinical pregnancy
Timepoint
12 day after embryo transfer
Method of measurement
Measurement of Bhcg

Secondary outcomes

empty

Intervention groups

1

Description
Cervical mucus was aspirated in 60 patients before embryo transfer
Category
Other

2

Description
No intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Infertility clinic
Full name of responsible person
Roya Kabodmehri
Street address
Fatemye hospital
City
Hamedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
vice chancellor for research of Hamedan University of Medical Sciences
Full name of responsible person
Dr. Heydar Tavilani
Street address
Shahid Fahmideh
City
Hamedan
Grant name
4100000
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice chancellor for research of Hamedan 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
Hamedan university of Medical Sciences
Full name of responsible person
Dr. Heydar Tavilani
Position
Vice chancellor for research
Other areas of specialty/work
Street address
Hamedan university of Medical Sciences
City
Hamedan
Postal code
65178/518
Phone
+98 81 1838 0130
Fax
Email
vc-research@umsha.ac.ir m research@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Soghra Rabiee
Position
infertilitist
Other areas of specialty/work
Street address
Fatemye hospital
City
Hamedan
Postal code
Phone
+98 81 1827 7012
Fax
Email
rabiee sogol@yahoo.com rabiei@umsha.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamedan university of Medical Sciences
Full name of responsible person
Roya Kabodmehri
Position
student
Other areas of specialty/work
Street address
Fatemye hospital
City
Hamedan
Postal code
Phone
+98 81 1827 7012
Fax
Email
r .kabodmehri@umsha.ac.ir
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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