The Benefits of Intracytoplasmic Morphologically Selected Sperm Injection (IMSI) in Couples With Unexplained Infertility

Pregnancy Clinical Trial

Official title:

The Benefits of Intracytoplasmic Morphologically Selected Sperm Injection (IMSI) in Couples With Unexplained Infertility

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01729533
• Other study ID #: IMSI_unexplained infertility
• Status: Withdrawn
• Phase: N/A
• First received: November 14, 2012
• Last updated: November 17, 2014
• Start date: December 2012
• Est. completion date: February 2013

Study information

• Verified date: November 2014
• Source: Sapientiae Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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)

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)

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A to 36 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Infertility
• Pregnancy

Intervention

Other:
• ICSI
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.
• IMSI
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.

Locations

Country	Name	City	State
Brazil	Sapientiae Institute	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	Pregnancy rate	Number of pregnancies divided by the number of cycles with embryo transfer	1 month	No