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

Not Applicable

Withdrawn

• Conditions: Pregnancy
• Interventions: Other: ICSI; Other: IMSI

• Registration Number: NCT01729533
• Lead Sponsor: Sapientiae Institute

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)

Study Timeline

• Study First Submitted: 2012-11-14
• Study First Submitted QC: 2012-11-19
• Study First Posted: 2012-11-20
• Study Start: 2012-12
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-17
• Last Update Posted: 2014-11-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ICSI	ICSI	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.
IMSI	IMSI	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.

Primary Outcome Measures

Name	Time	Method
Pregnancy rate	1 month	Number of pregnancies divided by the number of cycles with embryo transfer

Trial Locations

Locations (1)

Sapientiae Institute; 🇧🇷 São Paulo, Brazil