IMSI in Couples With Previous Implantation Failures

Not Applicable

Terminated

• Conditions: Male Infertility; Female Infertility
• Interventions: Other: Intracytoplasmic morphologically selected sperm injection; Other: Intracytoplasmic sperm injection

• Registration Number: NCT02107521
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-03
• Study First Submitted QC: 2014-04-03
• Study First Posted: 2014-04-08
• Status Verified: 2014-08
• Primary Completion: 2014-10
• Last Update Submitted: 2014-11-17
• Last Update Posted: 2014-11-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 25

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IMSI group	Intracytoplasmic morphologically selected sperm injection	In this group, sperm selected for injection will be morphologically evaluated under 6600x magnification
ICSI group	Intracytoplasmic sperm injection	In this group, sperm selected for injection will be morphologically evaluated under 400x magnification

Primary Outcome Measures

Name	Time	Method
Implantation	4-5 weeks' gestation	The presence of a gestational sac with heart beat, visualized upon ultrasound scan at 4-5 weeks' gestation

Trial Locations

Locations (1)

Fertility - Centro de Fertilização Assistida; 🇧🇷 Sao Paulo, Brazil