IMSI in Couples With Previous Implantation Failures

Male Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02107521
• Other study ID #: Sapi IMSI IF
• Status: Terminated
• Phase: N/A
• First received: April 3, 2014
• Last updated: November 17, 2014
• Start date: April 2014

Study information

• Verified date: August 2014
• Source: Sapientiae Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 38 Years

Eligibility

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. -

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Female Infertility
• Infertility
• Infertility, Female
• Infertility, Male
• Male Infertility

Intervention

Other:
• Intracytoplasmic morphologically selected sperm injection
Sperm selection for injection will be performed at 6600x magnification
• Intracytoplasmic sperm injection
sperm selection for injection will be performed under 400x magnification

Locations

Country	Name	City	State
Brazil	Fertility - Centro de Fertilização Assistida	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Sapientiae Institute

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implantation	The presence of a gestational sac with heart beat, visualized upon ultrasound scan at 4-5 weeks' gestation	4-5 weeks' gestation	No