Embryo Transfer: Embryo Expulsion and Outcome

April 17, 2010 updated by: Royan Institute

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."

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A total of 134 infertile women who undergo IVF or ICSI treatment cycle at Royan Institute (Infertility and Reproductive Medicine Research Centre) will enroll in this prospective randomized clinical trial study and will randomly be divided into two groups of 67 patients. This study has been approved by Royan ethics committee and written consent will be obtained from each patient. The patients with frozen-thawed embryo transfer cycle and those with oocyte donation cycle, the women with uterine abnormality and the subjects with submucosal and intramural myoma, will be excluded from this study.

After the ovarian stimulation and oocyte retrieval, The IVF and intracytoplasmic sperm injection (ICSI) procedures will be performed to produce the embryos.

Embryo transfer will be done only by one skilled physician. The patients will be divided into two groups of A and B by computerized randomly chart. In group A, the prevention technique of embryo expulsion will be carried out following embryo transfer, but no intervention will be performed in group B (control group).

After 2 weeks, the patients will be tested for serum β-hCG for assessing the pregnancy. The clinical pregnancy will be clarified by the number of women with gestational sacs on transvaginal sonography at 4-6 weeks of gestation. In the calculation of implantation, the number of gestational sacs will be considered.

Study Type

Interventional

Enrollment (Anticipated)

134

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control Group
Embryo transfer without any intervention
EXPERIMENTAL: Embryo Expulsion
Procedure: prevention of embryo expulsion
The prevention of embryo expulsion will be carried out after embryo transfer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical pregnancy
Time Frame: 4-6 weeks
4-6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Implantation rate
Time Frame: 6-7 weeks
6-7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royan Institute

Investigators

  • Principal Investigator: Tahere Madani, MD, Royan Institute
  • Principal Investigator: Mahnaz Ashrafi, MD, Royan Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (ACTUAL)

July 1, 2009

Study Completion (ACTUAL)

December 1, 2009

Study Registration Dates

First Submitted

May 20, 2009

First Submitted That Met QC Criteria

May 20, 2009

First Posted (ESTIMATE)

May 21, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

April 20, 2010

Last Update Submitted That Met QC Criteria

April 17, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Royan-Emb-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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