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

NCT01729533 | Withdrawn

• 1 other identifier: IMSI_unexplained infertility
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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)

Conditions

Pregnancy

Keywords

ICSI; IMSI; Pregnancy; Sperm morphology; Unexplained infertility

Outcome Measures

Primary Outcomes (1)

• Pregnancy rate

  Number of pregnancies divided by the number of cycles with embryo transfer

  1 month

Study Arms (2)

ICSI

ACTIVE COMPARATOR

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.

Other: ICSI

IMSI

EXPERIMENTAL

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.

Other: IMSI

Interventions

ICSI OTHER

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.

Also known as: Intracytoplasmic sperm injection

ICSI

IMSI OTHER

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.

Also known as: Intracytoplasmic morphologically selected sperm injection

IMSI

Eligibility Criteria

• Age: Up to 36 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sapientiae Institute: lead

Study Sites (1)

Sapientiae Institute

São Paulo, São Paulo, 04503040, Brazil

Location

MeSH Terms

Interventions

Sperm Injections, Intracytoplasmic

Intervention Hierarchy (Ancestors)

Fertilization in Vitro; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2012
• First Posted: November 20, 2012
• Study Start: December 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: November 18, 2014

Record last verified: 2014-11

Locations

BR (1)