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

Sapientiae Institute

Status: Withdrawn

Conditions: Pregnancy

Treatments: Other: IMSI; Other: ICSI

Study type: Interventional

Funder types: Other

Identifiers

NCT01729533

IMSI_unexplained infertility

Details and patient eligibility

About

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)

Full 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)

Sex: Female

Ages: Under 36 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

ICSI

Active Comparator group

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.

Treatment:

Other: ICSI

IMSI

Experimental group

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.

Treatment:

Other: IMSI