IMSI in Couples With Previous Implantation Failures

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02107521

Enrollment

Registered

2014-04-08

Start date

2014-04-30

Completion date

Unknown

Last updated

2014-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female Infertility, Male Infertility

Keywords

sperm morphology, ICSI, IMSI, implantation, pregnancy

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.

Interventions

OTHERIntracytoplasmic morphologically selected sperm injection

Sperm selection for injection will be performed at 6600x magnification

OTHERIntracytoplasmic sperm injection

sperm selection for injection will be performed under 400x magnification

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

No minimum to 38 Years

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. -

Design outcomes

Primary

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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026