Effect of Cervical Discharge Removal During ET on Pregnancy Rate

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01156181
• Other study ID #: Royan-Emb-007
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 1, 2010
• Last updated: September 20, 2011
• Start date: May 2009
• Est. completion date: May 2010

Study information

• Verified date: July 2010
• Source: Royan Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics CommitteeIran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 492
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Procedure:
• Cervical discharge removal
Cervical discharge will be removed using a cotton swab before embryo transfer during ICSI cycles
• control
Embryo transfer without any intervention

Locations

Country	Name	City	State
Iran, Islamic Republic of	Royan Institute	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Royan Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy rate		9 months after recruiting	No
Secondary	Fertilization rate		2 weeks	No
Secondary	Implantation rate		1 month	Yes
Secondary	Miscarriage rate		9 months	Yes
Secondary	Live birth rate		9 months	Yes

External Links

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