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Intracytoplasmic Morphologically Selected Sperm Injection and Advanced Maternal Age (IMSIAMA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sapientiae Institute
ClinicalTrials.gov Identifier:
NCT01620346
First received: June 13, 2012
Last updated: January 7, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Female Infertility
 Procedure: Intracytoplasmic sperm injection (ICSI)
Procedure: Intracytoplasmic morphologically selected sperm injection

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Intracytoplasmic Morphologically Selected Sperm Injection (IMSI) Benefits in the Presence of Advanced Maternal Age: a Prospective Randomized Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sapientiae Institute:

Primary Outcome Measures:
  • Implantation rate [ Time Frame: 6 weeks after embryo transfer ] [ Designated as safety issue: No ]
    Number of embryos implanted in the uterus divided for the number of embryos transferred.


Enrollment: 66
Study Start Date: November 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ICSI group
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.
 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.
Experimental: 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.
 Procedure: 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.

  Eligibility

Ages Eligible for Study:   37 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01620346

Locations
Brazil
Fertility - Assisted Fertilization Center
São Paulo, Brazil, 04512001
Sponsors and Collaborators
Sapientiae Institute
Investigators
Principal Investigator: Edson Borges Jr., MD., Ph.D Fertility - Assisted Fertilization Center and Sapientiae Institute - Educational and Research Center in Assisted Reproduction
  More Information

No publications provided

Responsible Party: Sapientiae Institute
ClinicalTrials.gov Identifier: NCT01620346     History of Changes
Other Study ID Numbers: Sapi2012_1
Study First Received: June 13, 2012
Last Updated: January 7, 2013
Health Authority: Brazil: Ethics Committee

Keywords provided by Sapientiae Institute:
advanced maternal age
infertility
IMSI
ICSI
implantation

Additional relevant MeSH terms:
Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 22, 2013