Effect of Cervical Discharge Removal During ET on Pregnancy Rate

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infertility

Intervention / Treatment
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* Procedure: Cervical discharge removal
* Procedure: control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate |  | 9 months after recruiting | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical mucus, Embryo transfer, ICSI cycle, Pregnancy rate