IMSI in Couples With Previous Implantation Failures

Study Overview
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Brief Summary
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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.

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

Conditions
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Male Infertility, Female Infertility

Intervention / Treatment
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* Other: Intracytoplasmic morphologically selected sperm injection
* Other: Intracytoplasmic sperm injection


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sperm morphology, ICSI, IMSI, implantation, pregnancy