Back to resultsThe Benefits of Intracytoplasmic Morphologically Selected Sperm Injection (IMSI) in Couples With Unexplained Infertility
Primary Purpose
Pregnancy
Status
Withdrawn
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
ICSI
IMSI
Sponsored by
About this trial
This is an interventional treatment trial for Pregnancy focused on measuring ICSI, IMSI, Pregnancy, Sperm morphology, Unexplained infertility
Eligibility Criteria
Inclusion Criteria:
- Women of good physical and mental health
- Undergoing assisted reproduction as a result of unexplained infertility
- Women with regular menstrual cycles of 25-35 days
- Women with normal basal follicle stimulating hormone (FSH) and luteinizing hormone (LH) levels
- Women with body mass index (BMI) less than 30 kg/m2
- Women with both ovaries and intact uterus
Exclusion Criteria:
- Men with abnormal semen parameters according to the 2010 WHO values
- Women with polycystic ovaries
- Women with endometriosis
- Women with gynaecological/medical disorders
- Women or men with a positive result for sexually transmitted diseases
- Women who had received hormone therapy for at least 60 days preceding the study
Sites / Locations
- Sapientiae Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
ICSI
IMSI
Arm Description
In this arm, patients will be provided with standard intracytoplasmic sperm injection (ICSI), in which sperm selection is performed under an overall magnification of x400.
In this arm, patients will be provided with a modified intracytoplasmic sperm injection (ICSI) procedure, the IMSI, in which sperm selection is performed under an overall magnification of x6600.
Outcomes
Primary Outcome Measures
Pregnancy rate
Number of pregnancies divided by the number of cycles with embryo transfer
Secondary Outcome Measures
Full Information
NCT ID
NCT01729533
First Posted
November 14, 2012
Last Updated
November 17, 2014
Sponsor
Sapientiae Institute
1. Study Identification
Unique Protocol Identification Number
NCT01729533
Brief Title
The Benefits of Intracytoplasmic Morphologically Selected Sperm Injection (IMSI) in Couples With Unexplained Infertility
Official Title
The Benefits of Intracytoplasmic Morphologically Selected Sperm Injection (IMSI) in Couples With Unexplained Infertility
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Withdrawn
Study Start Date
December 2012 (undefined)
Primary Completion Date
February 2013 (Anticipated)
Study Completion Date
February 2013 (Anticipated)
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 (motile sperm organelle morphology examination) MSOME allows the detection of sperm vacuoles that seems to be related to sperm DNA damage.
The investigators hypothesized that couples with unexplained infertility could benefit from the injection of spermatozoa selected under high-magnification (x6600)
Detailed Description
When routine infertility workup yields normal results in both partners, the couple is defined as suffering from unexplained infertility. These couples present normal semen analysis.
It has been reported that even infertile patients with normozoospermic parameters can have higher values of DNA damage than fertile controls.
It has been proposed that the use of ''invisible damaged'' spermatozoa could result in fertilization failure, impaired normal embryo development, reduced implantation and pregnancy rates.
The motile sperm organelle morphology examination (MSOME) allows the detection of sperm vacuoles that seems to be related to sperm DNA damage.
The investigators hypothesized that couples with unexplained infertility could benefit from the injection of spermatozoa selected under high-magnification (x6600)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy
Keywords
ICSI, IMSI, Pregnancy, Sperm morphology, Unexplained infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ICSI
Arm Type
Active Comparator
Arm Description
In this arm, patients will be provided with standard intracytoplasmic sperm injection (ICSI), in which sperm selection is performed under an overall magnification of x400.
Arm Title
IMSI
Arm Type
Experimental
Arm Description
In this arm, patients will be provided with a modified intracytoplasmic sperm injection (ICSI) procedure, the IMSI, in which sperm selection is performed under an overall magnification of x6600.
Intervention Type
Other
Intervention Name(s)
ICSI
Other Intervention Name(s)
Intracytoplasmic sperm injection
Intervention Description
ICSI Sperm selection in the ICSI group is analyzed under a magnification of 400x using an inverted microscope. ICSI is performed in a micro-injection dish prepared with 4 µL droplets of buffered medium and covered with paraffin oil on a heated stage at 37.0 ± 0.5°C of an inverted microscope.
Intervention Type
Other
Intervention Name(s)
IMSI
Other Intervention Name(s)
Intracytoplasmic morphologically selected sperm injection
Intervention Description
Sperm selection in the IMSI group is analyzed at high magnification using an inverted microscope equipped with high-power differential interference contrast optics. The total calculated magnification is x6.600. The sperm cells exhibiting normally shaped nuclei ([1] smooth, [2] symmetric, and [3] oval configuration) and [4] normal nuclear chromatin content (if it contained no more than one vacuole, which occupies <4% of the nuclear area) are selected for injection.
Primary Outcome Measure Information:
Title
Pregnancy rate
Description
Number of pregnancies divided by the number of cycles with embryo transfer
Time Frame
1 month
10. Eligibility
Sex
Female
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women of good physical and mental health
Undergoing assisted reproduction as a result of unexplained infertility
Women with regular menstrual cycles of 25-35 days
Women with normal basal follicle stimulating hormone (FSH) and luteinizing hormone (LH) levels
Women with body mass index (BMI) less than 30 kg/m2
Women with both ovaries and intact uterus
Exclusion Criteria:
Men with abnormal semen parameters according to the 2010 WHO values
Women with polycystic ovaries
Women with endometriosis
Women with gynaecological/medical disorders
Women or men with a positive result for sexually transmitted diseases
Women who had received hormone therapy for at least 60 days preceding the study
Facility Information:
Facility Name
Sapientiae Institute
City
São Paulo
ZIP/Postal Code
04503040
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
The Benefits of Intracytoplasmic Morphologically Selected Sperm Injection (IMSI) in Couples With Unexplained Infertility
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