NCT00905788

Brief Summary

According to the studies, about 80% of patients undergoing in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) reach to the embryo transfer process, but only a few of them become pregnant. The cause of this difference can be due to some factors such as the endometrial receptivity, quality of transferred embryos and embryo transfer technique. Retained or expelled embryo(s) following embryo transfer is (are) one of the factors which may be effective on outcome. The purpose of this randomized clinical trial study is "Lowering embryo expulsion following embryo transfer to improve outcome."

Trial Health

87
On Track

Trial Health Score

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

Enrollment
134

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2008

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

February 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 21, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

April 20, 2010

Status Verified

April 1, 2010

Enrollment Period

1.4 years

First QC Date

May 20, 2009

Last Update Submit

April 17, 2010

Conditions

Infertility

Keywords

Embryo transferIVF/ICSIEmbryo expulsion

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy

    4-6 weeks

Secondary Outcomes (1)

  • Implantation rate

    6-7 weeks

Study Arms (2)

Control Group

NO INTERVENTION

Embryo transfer without any intervention

Embryo Expulsion

EXPERIMENTAL
Procedure: prevention of embryo expulsion

Interventions

prevention of embryo expulsionPROCEDURE

The prevention of embryo expulsion will be carried out after embryo transfer

Embryo Expulsion

Eligibility Criteria

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

You may qualify if:

  • Women undergoing IVF or ICSI treatment cycle
  • Patients with "long or antagonist" protocol

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 Links

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Tahere Madani, MD

    Royan Institute

    PRINCIPAL INVESTIGATOR

  • Mahnaz Ashrafi, MD

    Royan Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 20, 2009

First Posted

May 21, 2009

Study Start

February 1, 2008

Primary Completion

July 1, 2009

Study Completion

December 1, 2009

Last Updated

April 20, 2010

Record last verified: 2010-04

Locations

IR(1)