NCT01156181

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
492

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2010

Completed
Last Updated

September 21, 2011

Status Verified

July 1, 2010

Enrollment Period

1 year

First QC Date

July 1, 2010

Last Update Submit

September 20, 2011

Conditions

Keywords

Cervical mucus, Embryo transfer, ICSI cycle, Pregnancy rate

Outcome Measures

Primary Outcomes (1)

  • Pregnancy rate

    9 months after recruiting

Secondary Outcomes (4)

  • Fertilization rate

    2 weeks

  • Implantation rate

    1 month

  • Miscarriage rate

    9 months

  • Live birth rate

    9 months

Study Arms (2)

Cervical discharge removal

EXPERIMENTAL

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

Procedure: Cervical discharge removal

Control

ACTIVE COMPARATOR

Embryo transfer without any intervention

Procedure: control

Interventions

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

Cervical discharge removal
controlPROCEDURE

Embryo transfer without any intervention

Control

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royan Institute

Tehran, Tehran Province, Iran

Location

Related Publications (1)

  • Moini A, Kiani K, Bahmanabadi A, Akhoond M, Akhlaghi A. Improvement in pregnancy rate by removal of cervical discharge prior to embryo transfer in ICSI cycles: a randomised clinical trial. Aust N Z J Obstet Gynaecol. 2011 Aug;51(4):315-20. doi: 10.1111/j.1479-828X.2011.01318.x. Epub 2011 Jun 9.

Related Links

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Ashraf Moini Moini, MD

    Academic staff of Endocrinology and Female Infertility Department, Royan Institute, Tehran - Iran

    STUDY CHAIR
  • Ladan Mohammadi yeganeh, MSc

    Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2010

First Posted

July 2, 2010

Study Start

May 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

September 21, 2011

Record last verified: 2010-07

Locations