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IMSI in Couples With Previous Implantation Failures

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ClinicalTrials.gov Identifier: NCT02107521
Recruitment Status : Terminated (broken equipment)
First Posted : April 8, 2014
Last Update Posted : November 18, 2014
Sponsor:
Information provided by (Responsible Party):
Sapientiae Institute

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.

Condition or disease Intervention/treatment Phase
Male Infertility Female Infertility Other: Intracytoplasmic morphologically selected sperm injection Other: Intracytoplasmic sperm injection Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : April 2014
Actual Primary Completion Date : October 2014


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



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   up to 38 Years   (Child, Adult)
Sexes 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. -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02107521


Locations
Brazil
Fertility - Centro de Fertilização Assistida
Sao Paulo, Brazil, 04503-040
Sponsors and Collaborators
Sapientiae Institute
Investigators
Principal Investigator: Edson Borges, PhD Sapientiae Institute

Responsible Party: Sapientiae Institute
ClinicalTrials.gov Identifier: NCT02107521     History of Changes
Other Study ID Numbers: Sapi IMSI IF
First Posted: April 8, 2014    Key Record Dates
Last Update Posted: November 18, 2014
Last Verified: August 2014

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

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