Effect of Cervical Discharge Removal During ET on Pregnancy Rate

September 20, 2011 updated by: Royan Institute

Effect of Cervical Discharge Removal Before Embryo Transfer on ICSI Cycle Outcomes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

492

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cervical discharge removal
Cervical discharge will be removed using a cotton swab before embryo transfer during ICSI cycles
Procedure: Cervical discharge removal
Cervical discharge will be removed using a cotton swab before embryo transfer during ICSI cycles
Active Comparator: Control
Embryo transfer without any intervention
Procedure: control
Embryo transfer without any intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pregnancy rate
Time Frame: 9 months after recruiting
9 months after recruiting

Secondary Outcome Measures

Outcome Measure
Time Frame
Miscarriage rate
Time Frame: 9 months
9 months
Live birth rate
Time Frame: 9 months
9 months
Implantation rate
Time Frame: 1 month
1 month
Fertilization rate
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royan Institute

Investigators

  • Study Chair: Ashraf Moini Moini, MD, Academic staff of Endocrinology and Female Infertility Department, Royan Institute, Tehran - Iran
  • Principal Investigator: Ladan Mohammadi yeganeh, MSc, Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

July 1, 2010

First Submitted That Met QC Criteria

July 1, 2010

First Posted (Estimate)

July 2, 2010

Study Record Updates

Last Update Posted (Estimate)

September 21, 2011

Last Update Submitted That Met QC Criteria

September 20, 2011

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Royan-Emb-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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