Intracytoplasmic Morphologically Selected Sperm Injection and Advanced Maternal Age

Female Infertility Clinical Trial

— IMSIAMA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01620346
• Other study ID #: Sapi2012_1
• Status: Completed
• Phase: N/A
• First received: June 13, 2012
• Last updated: January 7, 2013
• Start date: November 2011
• Est. completion date: August 2012

Study information

• Verified date: January 2013
• Source: Sapientiae Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 37 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Female Infertility
• Infertility
• Infertility, Female

Intervention

Procedure:
• Intracytoplasmic 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.
• Intracytoplasmic morphologically selected sperm injection
IMSI 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.

Locations

Country	Name	City	State
Brazil	Fertility - Assisted Fertilization Center	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Sapientiae Institute

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implantation rate	Number of embryos implanted in the uterus divided for the number of embryos transferred.	6 weeks after embryo transfer	No