IMSI in Couples With Previous Implantation Failures

November 17, 2014 updated by: Sapientiae Institute

The Effect of the Intracytoplasmic Morphologically Selected Sperm Injection in Couples With Previous Implantation Failure After Intracytoplasmic Sperm Injection

There is a lack of clarity regarding the justification to instruct the couple to shift from intracytoplasmic sperm injection (ICSI) to intracytoplasmic morphologically selected sperm injection (IMSI). In this study, we aim at evaluating the efficacy of IMSI in couples with previous implantation failure with ICSI.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

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

  • Brazil
      • Sao Paulo, Brazil, 04503-040
        • Fertility - Centro de Fertilização Assistida

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

No older than 38 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients with ICSI indication, who have previously underwent >= 1 ICSI attempt in which at least 2 blastocysts were transferred, with no implantation.
  • Regular menstrual cycles every 25-35 days.
  • Body Mass Index less than 35 as calculated according to the following formula: body weight (kg) / height x height (m2)
  • Presence of both ovaries.
  • No pelvic and / or clinically significant uterine anomalies.
  • Normal cervical cytology.
  • Serum follicle stimulating hormone (FSH) within normal limits.

Exclusion Criteria:

  • Clinically significant systemic disease.
  • Infection by the human immunodeficiency virus (HIV).
  • Infection by the by the hepatitis C virus
  • Positive test for surface antigens of hepatitis B.
  • Endometriosis stages III - IV (classification of the American Society for Reproductive Medicine).
  • Hydrosalpinx, unilateral or bilateral.
  • Abnormal gynecological bleeding, undiagnosed.
  • Allergy or hypersensitivity to human gonadotropin preparations or any other related to the study medication.

-Simultaneous participation in another clinical trial. -

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 Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ICSI group
In this group, sperm selected for injection will be morphologically evaluated under 400x magnification
Other: Intracytoplasmic sperm injection
sperm selection for injection will be performed under 400x magnification
Experimental: IMSI group
In this group, sperm selected for injection will be morphologically evaluated under 6600x magnification
Other: Intracytoplasmic morphologically selected sperm injection
Sperm selection for injection will be performed at 6600x magnification

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implantation
Time Frame: 4-5 weeks' gestation
The presence of a gestational sac with heart beat, visualized upon ultrasound scan at 4-5 weeks' gestation
4-5 weeks' gestation

Collaborators and Investigators

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

Sponsor

Sapientiae Institute

Investigators

  • Principal Investigator: Edson Borges, PhD, Sapientiae Institute

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

April 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

April 3, 2014

First Submitted That Met QC Criteria

April 3, 2014

First Posted (Estimate)

April 8, 2014

Study Record Updates

Last Update Posted (Estimate)

November 18, 2014

Last Update Submitted That Met QC Criteria

November 17, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sapi IMSI IF

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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