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Effect of Cervical Discharge Removal During ET on Pregnancy Rate

Primary Purpose

Infertility

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Cervical discharge removal
control
Sponsored by
Royan Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Cervical mucus, Embryo transfer, ICSI cycle, Pregnancy rate

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women who were candidate for fresh embryo transfer during IVF/ICSI cycles were eligible for this study if they had two or more good quality embryos and age fewer than 40

Exclusion Criteria:

  • The patients with frozen-thawed embryo transfer cycle
  • Those with oocyte donation cycle
  • The women with uterine abnormality
  • The women with submucosal and intramural myoma
  • Who does not have good-quality embryos appropriate

Sites / Locations

  • Royan Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cervical discharge removal

Control

Arm Description

Cervical discharge will be removed using a cotton swab before embryo transfer during ICSI cycles

Embryo transfer without any intervention

Outcomes

Primary Outcome Measures

Pregnancy rate

Secondary Outcome Measures

Fertilization rate
Implantation rate
Miscarriage rate
Live birth rate

Full Information

First Posted
July 1, 2010
Last Updated
September 20, 2011
Sponsor
Royan Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01156181
Brief Title
Effect of Cervical Discharge Removal During ET on Pregnancy Rate
Official Title
Effect of Cervical Discharge Removal Before Embryo Transfer on ICSI Cycle Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royan Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Pregnancy rate may be affected by multiple factors such as embryo transfer techniques. Even small differences in embryo transfer methods may affect pregnancy rates. There is an inconsistency about the effect of the removal of cervical discharge on embryo transfer outcomes. Some studies showed that cervical mucus removal before embryo transfer can increase pregnancy rate, however the others could not find any significant effect about the removal of cervical mucus on pregnancy or live birth rates. Given to the conflicting evidences, our study aimed to determine whether the cervical discharge removal has positive effect on pregnancy rate.
Detailed Description
492 Infertile women who were candidate for fresh embryo transfer during IVF/ICSI cycles were eligible for this study if they had two or more good quality embryos. All categories of female or male factors infertility except uterine factor infertility were eligible for participation in the study. Immediately prior to embryo transfer, women were randomly allocated to either treatment (cleaning the cervical canal) or control groups. In treatment group, excess mucus and debris were cleared from the cervical canal using a sterile cotton swabs. The cervical discharge was scored as mucosal, bloody, combination of mucosal and bloody, or infected. Control group had no cervical cleaning before embryo transfer. Then, the embryos were loaded into the transfer catheter by the embryologist and were deposited into the uterine cavity by one experience physician. The primary endpoint was clinical pregnancy. Fertilization, Implantation, abortion, and live birth rates were the other outcomes of interest or secondary outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Cervical mucus, Embryo transfer, ICSI cycle, Pregnancy rate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
492 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cervical discharge removal
Arm Type
Experimental
Arm Description
Cervical discharge will be removed using a cotton swab before embryo transfer during ICSI cycles
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Embryo transfer without any intervention
Intervention Type
Procedure
Intervention Name(s)
Cervical discharge removal
Intervention Description
Cervical discharge will be removed using a cotton swab before embryo transfer during ICSI cycles
Intervention Type
Procedure
Intervention Name(s)
control
Intervention Description
Embryo transfer without any intervention
Primary Outcome Measure Information:
Title
Pregnancy rate
Time Frame
9 months after recruiting
Secondary Outcome Measure Information:
Title
Fertilization rate
Time Frame
2 weeks
Title
Implantation rate
Time Frame
1 month
Title
Miscarriage rate
Time Frame
9 months
Title
Live birth rate
Time Frame
9 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women who were candidate for fresh embryo transfer during IVF/ICSI cycles were eligible for this study if they had two or more good quality embryos and age fewer than 40 Exclusion Criteria: The patients with frozen-thawed embryo transfer cycle Those with oocyte donation cycle The women with uterine abnormality The women with submucosal and intramural myoma Who does not have good-quality embryos appropriate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashraf Moini Moini, MD
Organizational Affiliation
Academic staff of Endocrinology and Female Infertility Department, Royan Institute, Tehran - Iran
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ladan Mohammadi yeganeh, MSc
Organizational Affiliation
Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royan Institute
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
21806579
Citation
Moini A, Kiani K, Bahmanabadi A, Akhoond M, Akhlaghi A. Improvement in pregnancy rate by removal of cervical discharge prior to embryo transfer in ICSI cycles: a randomised clinical trial. Aust N Z J Obstet Gynaecol. 2011 Aug;51(4):315-20. doi: 10.1111/j.1479-828X.2011.01318.x. Epub 2011 Jun 9.
Results Reference
derived
Links:
URL
http://www.royaninstitute.org
Description
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Effect of Cervical Discharge Removal During ET on Pregnancy Rate

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