Motile Sperm Organelle Morphology Examination (MSOME) Influence on Intracytoplasmic Sperm Injection (ICSI) Outcomes in Infertile Couples
|ClinicalTrials.gov Identifier: NCT01731639|
Recruitment Status : Completed
First Posted : November 22, 2012
Last Update Posted : November 18, 2014
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy||Other: MSOME||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||The Influence of Motile Sperm Organelle Morphology Examination on ICSI Outcomes|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
The samples will be evaluated under high magnification
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.
- Pregnancy rates [ Time Frame: 1 month ]Number of clinical pregnancy rate divided by the number of couples in which embryo transfer was performed.
- Implantation rates [ Time Frame: 1 month ]Number of gestational sacs divided by the number of transferred embryos.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01731639
|São Paulo, Brazil, 04503-040|
|Principal Investigator:||Edson Borges Jr., MD., PhD||Sapientiae Institute|