Intracytoplasmic Morphologically Selected Sperm Injection and Advanced Maternal Age

Not Applicable

Completed

• Conditions: Female Infertility
• Interventions: Procedure: Intracytoplasmic sperm injection (ICSI); Procedure: Intracytoplasmic morphologically selected sperm injection

• Registration Number: NCT01620346
• Lead Sponsor: Sapientiae Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-06-13
• Study First Submitted QC: 2012-06-14
• Study First Posted: 2012-06-15
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-07
• Last Update Posted: 2013-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 66

Inclusion Criteria

• Good physical and mental health
• Advanced maternal age (≥ 37 years old)
• Regular menstrual cycles of 25-35 days
• Normal basal FSH and LH levels
• Body mass index less than 30 kg/m2
• Presence of both ovaries
• Intact uterus
• No hormone therapy for at least 60 days preceding the study

Exclusion Criteria

• Polycystic ovaries
• Endometriosis
• Gynaecological/medical disorders
• Positive result in a screening for sexually transmitted diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ICSI group	Intracytoplasmic sperm injection (ICSI)	This group was provided with conventional intracytoplasmic sperm injection (ICSI). This treatment is routinely used to treat infertility. Sperm selection in the ICSI group is analysed under a magnification of 400x using an inverted microscope.
Intracytoplasmic morphologically selected sperm injection	Intracytoplasmic morphologically selected sperm injection	Intracytoplasmic morphologically selected sperm injection (IMSI) is an established modified ICSI procedure. 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.

Primary Outcome Measures

Name	Time	Method
Implantation rate	6 weeks after embryo transfer	Number of embryos implanted in the uterus divided for the number of embryos transferred.

Trial Locations

Locations (1)

Fertility - Assisted Fertilization Center; 🇧🇷 São Paulo, Brazil