IMSI in Couples With Previous Implantation Failures

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Sapientiae Institute
Sponsor:
Information provided by (Responsible Party):
Sapientiae Institute
ClinicalTrials.gov Identifier:
NCT02107521
First received: April 3, 2014
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Male Infertility
Female Infertility
Other: Intracytoplasmic morphologically selected sperm injection
Other: Intracytoplasmic sperm injection

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of the Intracytoplasmic Morphologically Selected Sperm Injection in Couples With Previous Implantation Failure After Intracytoplasmic Sperm Injection

Resource links provided by NLM:


Further study details as provided by Sapientiae Institute:

Primary Outcome Measures:
  • Implantation [ Time Frame: 4-5 weeks' gestation ] [ Designated as safety issue: No ]
    The presence of a gestational sac with heart beat, visualized upon ultrasound scan at 4-5 weeks' gestation


Estimated Enrollment: 186
Study Start Date: April 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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. -

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02107521

Contacts
Contact: Edson Borges Jr., PhD 551130188181 science@fertility.com.br

Locations
Brazil
Fertility - Centro de Fertilização Assistida Recruiting
Sao Paulo, Brazil, 04503-040
Contact: Edson Borges, PhD    55113018818    science@sapientiae.org.br   
Sub-Investigator: Amanda S Raize, B.Sc.         
Sponsors and Collaborators
Sapientiae Institute
Investigators
Principal Investigator: Edson Borges, PhD Sapientiae Institute
  More Information

No publications provided

Responsible Party: Sapientiae Institute
ClinicalTrials.gov Identifier: NCT02107521     History of Changes
Other Study ID Numbers: Sapi IMSI IF
Study First Received: April 3, 2014
Last Updated: August 5, 2014
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Sapientiae Institute:
sperm morphology
ICSI
IMSI
implantation
pregnancy

Additional relevant MeSH terms:
Infertility
Infertility, Female
Infertility, Male
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 20, 2014