IMSI in Couples With Previous Implantation Failures

NCT02107521 | Terminated

• 1 other identifier: Sapi IMSI IF
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Male Infertility; Female Infertility

Keywords

sperm morphology; ICSI; IMSI; implantation; pregnancy

Outcome Measures

Primary Outcomes (1)

• Implantation

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

  4-5 weeks' gestation

Study Arms (2)

ICSI group

ACTIVE COMPARATOR

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

Other: Intracytoplasmic sperm injection

IMSI group

EXPERIMENTAL

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

Other: Intracytoplasmic morphologically selected sperm injection

Interventions

Intracytoplasmic morphologically selected sperm injection OTHER

Sperm selection for injection will be performed at 6600x magnification

IMSI group

Intracytoplasmic sperm injection OTHER

sperm selection for injection will be performed under 400x magnification

ICSI group

Eligibility Criteria

• Age: Up to 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Sapientiae Institute: lead

Study Sites (1)

Fertility - Centro de Fertilização Assistida

São Paulo, São Paulo, 04503-040, Brazil

Location

MeSH Terms

Conditions

Infertility, Male; Infertility, Female

Interventions

Sperm Injections, Intracytoplasmic

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

Fertilization in Vitro; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques

Study Officials

• Edson Borges, PhD

  Sapientiae Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2014
• First Posted: April 8, 2014
• Study Start: April 1, 2014
• Primary Completion: October 1, 2014
• Last Updated: November 18, 2014

Record last verified: 2014-08

Locations

BR (1)