Effect of Cervical Discharge Removal During ET on Pregnancy Rate

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Royan Institute
ClinicalTrials.gov Identifier:
NCT01156181
First received: July 1, 2010
Last updated: September 20, 2011
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Infertility
Procedure: Cervical discharge removal
Procedure: control
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Effect of Cervical Discharge Removal Before Embryo Transfer on ICSI Cycle Outcomes

Resource links provided by NLM:


Further study details as provided by Royan Institute:

Primary Outcome Measures:
  • Pregnancy rate [ Time Frame: 9 months after recruiting ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fertilization rate [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Implantation rate [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Miscarriage rate [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Live birth rate [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Enrollment: 492
Study Start Date: May 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cervical discharge removal
Cervical discharge will be removed using a cotton swab before embryo transfer during ICSI cycles
Procedure: Cervical discharge removal
Cervical discharge will be removed using a cotton swab before embryo transfer during ICSI cycles
Active Comparator: Control
Embryo transfer without any intervention
Procedure: control
Embryo transfer without any intervention

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01156181

Locations
Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Royan Institute
Investigators
Study Chair: Ashraf Moini Moini, MD Academic staff of Endocrinology and Female Infertility Department, Royan Institute, Tehran - Iran
Principal Investigator: Ladan Mohammadi yeganeh, MSc Investigator
  More Information

Additional Information:
No publications provided by Royan Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT01156181     History of Changes
Other Study ID Numbers: Royan-Emb-007
Study First Received: July 1, 2010
Last Updated: September 20, 2011
Health Authority: Iran: Ethics Committee
Iran: Ministry of Health

Keywords provided by Royan Institute:
Cervical mucus, Embryo transfer, ICSI cycle, Pregnancy rate

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 01, 2014