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

Primary Purpose

Female Infertility

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Intracytoplasmic sperm injection (ICSI)
Intracytoplasmic morphologically selected sperm injection
Sponsored by
Sapientiae Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Female Infertility focused on measuring advanced maternal age, infertility, IMSI, ICSI, implantation

Eligibility Criteria

37 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Fertility - Assisted Fertilization Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

ICSI group

Intracytoplasmic morphologically selected sperm injection

Arm Description

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 (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.

Outcomes

Primary Outcome Measures

Implantation rate
Number of embryos implanted in the uterus divided for the number of embryos transferred.

Secondary Outcome Measures

Full Information

First Posted
June 13, 2012
Last Updated
January 7, 2013
Sponsor
Sapientiae Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01620346
Brief Title
Intracytoplasmic Morphologically Selected Sperm Injection and Advanced Maternal Age
Acronym
IMSIAMA
Official Title
Intracytoplasmic Morphologically Selected Sperm Injection (IMSI) Benefits in the Presence of Advanced Maternal Age: a Prospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sapientiae Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Infertility
Keywords
advanced maternal age, infertility, IMSI, ICSI, implantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ICSI group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intracytoplasmic morphologically selected sperm injection
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Intracytoplasmic sperm injection (ICSI)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Intracytoplasmic morphologically selected sperm injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Implantation rate
Description
Number of embryos implanted in the uterus divided for the number of embryos transferred.
Time Frame
6 weeks after embryo transfer

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edson Borges Jr., MD., Ph.D
Organizational Affiliation
Fertility - Assisted Fertilization Center and Sapientiae Institute - Educational and Research Center in Assisted Reproduction
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fertility - Assisted Fertilization Center
City
São Paulo
ZIP/Postal Code
04512001
Country
Brazil

12. IPD Sharing Statement

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Intracytoplasmic Morphologically Selected Sperm Injection and Advanced Maternal Age

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