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Effect of Cervical Discharge Removal During ET on Pregnancy Rate

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01156181
Enrollment
492
Registered
2010-07-02
Start date
2009-05-31
Completion date
2010-05-31
Last updated
2011-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

Cervical mucus, Embryo transfer, ICSI cycle, Pregnancy rate

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.

Interventions

PROCEDURECervical discharge removal

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

PROCEDUREcontrol

Embryo transfer without any intervention

Sponsors

Royan Institute
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Pregnancy rate9 months after recruiting

Secondary

MeasureTime frame
Fertilization rate2 weeks
Implantation rate1 month
Miscarriage rate9 months
Live birth rate9 months

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026