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

NCT02520869 | Withdrawn Phase 2

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

Brief 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

Outcome Measures

Primary Outcomes (1)

• Percentage of spermatozoa with fragmented DNA before and after processing

  Semen samples will be collected by masturbation in clean containers, usually after 2-3 days of abstinence

  after taking semen sample by 30 minutes

Secondary Outcomes (1)

• reproductive success

  pregnancy test done 15 days after the embryo transfer.

Study Arms (2)

swim-up

ACTIVE COMPARATOR

swim-up technique for semen processing

Procedure: swim-up technique

zeta test

ACTIVE COMPARATOR

zeta test technique for semen processing

Procedure: zeta test technique

Interventions

swim-up technique PROCEDURE

swim-up technique used

swim-up

zeta test technique PROCEDURE

zeta test technique used

zeta test

Eligibility Criteria

• Age: 19 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• written informed consent for the ICSI treatment
• Female body mass index of 18-30 kg/m2
• No congenital uterine anomalies in gynecological ultrasound of female partner
• Male partner not under pharmacological treatment
• couples undergoes ICSI procedures with ejaculated sperm will be included and - Sperm count not less than 0.1 Million per ML
• Male abstinence period 2-3 days.

You may not qualify if:

• women over 42 years old
• acute infectious diseases
• systemic illnesses
• Treatment cycles that will result in a poor ovarian response (\<3 mature oocytes collected) or those involving epididymal, testicular and cryopreserved sperm samples
• Male patients having varicocele, oligospermia
• male partner under pharmacological treatment

Sponsors & Collaborators

• khalid abd aziz mohamed: lead

Study Sites (1)

Benha Faculty of Medicine

Banhā, El Qaluobia, 13518, Egypt

Location

Study Officials

• wagdy amer, MD

  lecturer

  PRINCIPAL INVESTIGATOR

• abo baker el nashar, MD

  professor

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: lecutrer

Study Record Dates

• First Submitted: August 4, 2015
• First Posted: August 13, 2015
• Study Start: April 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: May 1, 2016
• Last Updated: September 20, 2016

Record last verified: 2016-09

Locations

EG (1)