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OpenTrials
Completed

NCT Number: NCT01156181

Effect of Cervical Discharge Removal During ET on Pregnancy Rate

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Royan Institute

Tehran, Tehran Province, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cervical discharge removal

Procedure

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

Control

Procedure

Embryo transfer without any intervention

Primary outcomes

  1. Pregnancy rate

    Time frame: 9 months after recruiting

Secondary outcomes

  1. Fertilization rate

    Time frame: 2 weeks

  2. Implantation rate

    Time frame: 1 month

  3. Miscarriage rate

    Time frame: 9 months

  4. Live birth rate

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

Royan Institute

Other Gov

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 2, 2010
Registry last updated
Sep 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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