NCT01731639

Brief Summary

A new technique based on the motile sperm organelle morphology examination (MSOME) at a magnification of at least ×6000 has been developed. The MSOME assesses the nucleus, for both shape and chromatin content, which is the most important sperm organelle in influencing intracytoplasmic sperm injection (ICSI) outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started Jan 2013

Shorter than P25 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 22, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

November 18, 2014

Status Verified

November 1, 2014

Enrollment Period

11 months

First QC Date

November 12, 2012

Last Update Submit

November 17, 2014

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

  • Pregnancy rates

    Number of clinical pregnancy rate divided by the number of couples in which embryo transfer was performed.

    1 month

Secondary Outcomes (1)

  • Implantation rates

    1 month

Study Arms (1)

MSOME

EXPERIMENTAL

The samples will be evaluated under high magnification

Other: MSOME

Interventions

MSOMEOTHER

The semen samples will be evaluated according to the 2010 WHO reference values. After ICSI 200 spermatozoa of each sample will be analyzed under high magnification (MSOME - x6600) and graded into four groups according to the presence or size of the vacuoles. Grade I: normal form and no vacuoles; grade II: normal form and ≤ 2 small vacuoles; grade III: normal form \> 2 small vacuoles or at least one large vacuole and grade IV: large vacuole and abnormal head shapes or other abnormalities.

MSOME

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Couples undergoing ICSI as result of male factor or tubal factor or 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:

  • Women with polycystic ovaries syndrome
  • Women with endometriosis
  • Women with gynaecological/medical disorders
  • Couples with any sexually transmitted disease
  • Women who had received any hormone therapy for less than 60 days preceding the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sapientiae Institute

São Paulo, São Paulo, 04503-040, Brazil

Location

Study Officials

  • Edson Borges Jr., MD., PhD

    Sapientiae Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2012

First Posted

November 22, 2012

Study Start

January 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

November 18, 2014

Record last verified: 2014-11

Locations

BR(1)