IMSI in Couples With Previous Implantation Failures

Sapientiae Institute

Status: Terminated

Conditions: Female Infertility; Male Infertility

Treatments: Other: Intracytoplasmic sperm injection; Other: Intracytoplasmic morphologically selected sperm injection

Study type: Interventional

Funder types: Other

Identifiers

NCT02107521

Sapi IMSI IF

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: Female

Ages: Under 38 years old

Volunteers: No 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. -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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25 participants in 2 patient groups

ICSI group

Active Comparator group

Description:

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

Treatment:

Other: Intracytoplasmic sperm injection

IMSI group

Experimental group

Description:

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

Treatment:

Other: Intracytoplasmic morphologically selected sperm injection