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Diagnostic Value of Sperm DNA Fragmentation and Sperm Morphology for Assisted Reproduction Treatment

NCT02520869 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2016-09-20

No results posted yet for this study

Summary

All patients will go through an ICSI (intracytoplasmic sperm injection)cycle Monitoring: COH (controlled ovarian hyperstimulation) will be monitored by transvaginal sonography, and then the dose of gonadotropin will be adjusted according to the follicle size and number.

Triggering ovulation: when three or more follicles reach \>18mm, endometrium triple line \>8mm, both the gonadotropin and agonist injections will be stopped and 10,000 IU of hCG(human chorionic gonadotropin ) will be given.

Egg collection : 34-36 hour after hCG injection, embryo transfer :48-72 hour after oocyte retrieval. Luteal phase support: with 100 mg progesterone injection IM daily until the day of the pregnancy test pregnancy test: 15 days after the embryo transfer. Semen collection and preparation Semen samples will be collected by masturbation in clean containers, usually after 2-3 days of abstinence. Each sample will be allowed to liquefy for at least 20 min at 37 °C.

Semen analysis:

Basic sperm parameters including sperm count, concentration, motility and morphology will be evaluated according to World Health Organization guidelines. After the initial assessment, ejaculates will be divided into three aliquots. An aliquot of each sample will be used to assess sperm DNA damage, the second aliquot will be processed by direct swim-up technique (n 30) or zeta test technique (n 30) this will be followed by assessment of DNA damage again in each sample to measure the difference in DNA damage after processing in each technique then spermatozoa from the third aliquot will be morphologically analyzed manually using Spermic stain and a light microscope and will be scored according to WHO

Conditions

  • Assisted Reproductive Technology

Interventions

PROCEDURE

swim-up technique

swim-up technique used

PROCEDURE

zeta test technique

zeta test technique used

Sponsors & Collaborators

  • khalid abd aziz mohamed

    lead OTHER

Principal Investigators

  • wagdy amer, MD · lecturer

  • abo baker el nashar, MD · professor

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-04-30
Completion
2016-05-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02520869 on ClinicalTrials.gov