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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

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

NCT ID

NCT02107521

First Posted

April 3, 2014

Last Updated

November 17, 2014

Sponsor

Sapientiae Institute

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

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

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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