Influence of Sperm With Large Nuclear Vacuole on ICSI Outcomes
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Purpose
Current research on sperm morphology has been directed towards the dysmorphisms of the sperm head. A new technique based on the motile sperm organelle morphology examination (MSOME) allows the detection of sperm with large nuclear vacuoles (SLV). Large nuclear vacuoles are specific sperm alterations observed under high magnification, and their presence has been related to increased DNA fragmentation and denaturation.
| Condition | Intervention |
|---|---|
|
Pregnancy |
Other: MSOME |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Diagnostic |
| Official Title: | Influence of Sperm With Large Nuclear Vacuoles on the Cycles' Outcomes of Couples Couples Undergoing ICSI |
- Pregnancy [ Time Frame: 1 month ] [ Designated as safety issue: No ]Number of clinical pregnancy rate divided by the number of couples in which embryo transfer was performed
| Estimated Enrollment: | 200 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: MSOME
Couples in which the sperm cells were analysed through MSOME
|
Other: MSOME
A total of 200 spermatozoa of each sample will be analyzed under high magnification (x6600) and the incidence of SLV (sperm cells presenting at least one vacuole that occupied > 13% of nuclear area) in each sample will be assessed.
|
Detailed Description:
A new method for the detailed morphological evaluation of motile spermatozoa in real time, under high magnification, named "motile sperm organellar morphology examination" (MSOME) was developed. This magnification provides an accurate description of spermatozoa abnormalities, particularly the presence of head vacuoles, which is indicative of abnormal chromatin packaging in spermatozoa. However, the influence of sperm with large nuclear vacuoles (SLV) on ART outcomes is still a matter of debate. The goals for this study were to identify whether there is a connection between SLV under high magnification and ICSI outcomes.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Couples undergoing intracytoplasmic sperm injection (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
Exclusion Criteria:
- 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
Contacts and Locations| Contact: Edson Borges Jr., MD., PhD | 551130188181 | edson@fertility.com.br |
| Brazil | |
| Sapientiae Institute | Recruiting |
| Sao Paulo, SP, Brazil, 04503-040 | |
| Contact: Edson Borges Jr., MD., PhD 551130188181 edson@fertility.com.br | |
| Principal Investigator: Edson Borges Jr., MD., PhD | |
| Principal Investigator: | Edson Borges Jr., MD., PhD | Sapientiae Institute |
More Information
No publications provided
| Responsible Party: | Sapientiae Institute |
| ClinicalTrials.gov Identifier: | NCT01727947 History of Changes |
| Other Study ID Numbers: | MSOME_SLV |
| Study First Received: | November 12, 2012 |
| Last Updated: | January 7, 2013 |
| Health Authority: | Brazil: Ethics Committee |
ClinicalTrials.gov processed this record on June 18, 2013