Effect of Cervical Discharge Removal During ET on Pregnancy Rate

Phase 2

Completed

• Conditions: Infertility
• Interventions: Procedure: Cervical discharge removal; Procedure: control

• Registration Number: NCT01156181
• Lead Sponsor: Royan Institute

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.

Study Timeline

• Study Start: 2009-05
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2010-07
• Study First Submitted: 2010-07-01
• Study First Submitted QC: 2010-07-01
• Study First Posted: 2010-07-02
• Last Update Submitted: 2011-09-20
• Last Update Posted: 2011-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 492

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cervical discharge removal	Cervical discharge removal	Cervical discharge will be removed using a cotton swab before embryo transfer during ICSI cycles
Control	control	Embryo transfer without any intervention

Primary Outcome Measures

Name	Time	Method
Pregnancy rate	9 months after recruiting

Secondary Outcome Measures

Name	Time	Method
Fertilization rate	2 weeks
Implantation rate	1 month
Miscarriage rate	9 months
Live birth rate	9 months

Trial Locations

Locations (1)

Royan Institute; 🇮🇷 Tehran, Iran, Islamic Republic of