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IMSI in Couples With Previous Implantation Failures

Primary Purpose

Male Infertility, Female Infertility

Status
Terminated
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Intracytoplasmic morphologically selected sperm injection
Intracytoplasmic sperm injection
Sponsored by
Sapientiae Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Male Infertility focused on measuring sperm morphology, ICSI, IMSI, implantation, pregnancy

Eligibility Criteria

undefined - 38 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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. -

Sites / Locations

  • Fertility - Centro de Fertilização Assistida

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

ICSI group

IMSI group

Arm Description

In this group, sperm selected for injection will be morphologically evaluated under 400x magnification

In this group, sperm selected for injection will be morphologically evaluated under 6600x magnification

Outcomes

Primary Outcome Measures

Implantation
The presence of a gestational sac with heart beat, visualized upon ultrasound scan at 4-5 weeks' gestation

Secondary Outcome Measures

Full Information

First Posted
April 3, 2014
Last Updated
November 17, 2014
Sponsor
Sapientiae Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02107521
Brief Title
IMSI in Couples With Previous Implantation Failures
Official Title
The Effect of the Intracytoplasmic Morphologically Selected Sperm Injection in Couples With Previous Implantation Failure After Intracytoplasmic Sperm Injection
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Terminated
Why Stopped
broken equipment
Study Start Date
April 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sapientiae Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male Infertility, Female Infertility
Keywords
sperm morphology, ICSI, IMSI, implantation, pregnancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ICSI group
Arm Type
Active Comparator
Arm Description
In this group, sperm selected for injection will be morphologically evaluated under 400x magnification
Arm Title
IMSI group
Arm Type
Experimental
Arm Description
In this group, sperm selected for injection will be morphologically evaluated under 6600x magnification
Intervention Type
Other
Intervention Name(s)
Intracytoplasmic morphologically selected sperm injection
Intervention Description
Sperm selection for injection will be performed at 6600x magnification
Intervention Type
Other
Intervention Name(s)
Intracytoplasmic sperm injection
Intervention Description
sperm selection for injection will be performed under 400x magnification
Primary Outcome Measure Information:
Title
Implantation
Description
The presence of a gestational sac with heart beat, visualized upon ultrasound scan at 4-5 weeks' gestation
Time Frame
4-5 weeks' gestation

10. Eligibility

Sex
Female
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edson Borges, PhD
Organizational Affiliation
Sapientiae Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fertility - Centro de Fertilização Assistida
City
Sao Paulo
ZIP/Postal Code
04503-040
Country
Brazil

12. IPD Sharing Statement

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IMSI in Couples With Previous Implantation Failures

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