Clinical Trials Directory

Trials / Completed

CompletedNCT01620346

Intracytoplasmic Morphologically Selected Sperm Injection and Advanced Maternal Age

Intracytoplasmic Morphologically Selected Sperm Injection (IMSI) Benefits in the Presence of Advanced Maternal Age: a Prospective Randomized Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
66 (actual)
Sponsor
Sapientiae Institute · Academic / Other
Sex
Female
Age
37 Years
Healthy volunteers
Not accepted

Summary

The objective of this study was to evaluate the advanced maternal age as a rationale for performing intracytoplasmic morphologically selected sperm injection (IMSI). This prospective randomized study included couples undergoing intracytoplasmic sperm injection (ICSI) as a result of advanced maternal age (≥ 37 years old). Couples were randomly allocated to receive one of two sperm selection procedures (ICSI, n = 33; or IMSI, n = 33). The groups were compared with regard to fertilization rate, percentage of high-quality embryos, implantation, pregnancy and miscarriage rates.

Conditions

Interventions

TypeNameDescription
PROCEDUREIntracytoplasmic sperm injection (ICSI)ICSI is routinely used to treat couples with infertility. Sperm selection in the ICSI group was analysed under a magnification of 400x using an inverted microscope. ICSI was performed in a micro-injection dish prepared with 4 µL droplets of buffered medium (Global® w/HEPES, LifeGlobal, Connecticut, USA) and covered with paraffin oil on a heated stage at 37.0 ± 0.5°C of an inverted microscope.
PROCEDUREIntracytoplasmic morphologically selected sperm injectionIMSI is an established modified ICSI procedure that used an unstained real-time observation of spermatozoa under high-magnification. Sperm selection in the IMSI group is examined at high magnification using an inverted microscope equipped with high-power differential interference contrast optics (DIC/Nomarski). The total calculated magnification is x6.600. The sperm cells exhibiting normally shaped nuclei and normal nuclear chromatin content are selected for injection.

Timeline

Start date
2011-11-01
Primary completion
2012-08-01
Completion
2012-08-01
First posted
2012-06-15
Last updated
2013-01-08

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT01620346. Inclusion in this directory is not an endorsement.