Assisted Reproductive TechnologyPhase 2/3NCT02520869
Diagnostic Value of Sperm DNA Fragmentation and Sperm Morphology for Assisted Reproduction Treatment
A Phase 2/3 study testing swim-up technique and zeta test technique in people with Assisted Reproductive Technology, run by khalid abd aziz mohamed at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 42 years, women only
- Conditions the study is for
- Assisted Reproductive Technology
- What is being tested?
- swim-up technique and zeta test technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2014to May 2016
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Value of Sperm DNA Fragmentation and Sperm Morphology for Predicting Outcome of Assisted Reproduction Treatment
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.
Read more
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
Read the detailed description
This study will be carried out in private centers for IVF. The aim of this study is to determine the prognostic value of sperm DNA fragmentation levels before and after semen processing and sperm morphology in predicting the outcome of assisted reproduction.
60 couples will undergo ICSI cycles in private centers for IVF. All patients will go through an ICSI cycle. Monitoring: COH 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 more than 8mm, both the gonadotropin and agonist injections will be stopped and 10,000 IU of hCG 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 intramuscularly 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.
DNA fragmentation assay:
The assessment of DNA damage will be measured before and after processing for each sample using an improved version of the sperm chromatin dispersion test. Samples will be prepared for analysis. staining step will be required to evaluate the prepared slides. The samples will be stained with Diff-Quik solution, immersing each slide in Diff-Quik solution I (eosinophilic) and Diff-Quik solution II (basophilic) for 6 min each, allowed to dry at room temperature .then the slide will be examined under bright field microscope.
- Conditions
- Assisted Reproductive Technology
- Being tested
- swim-up technique, zeta test technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
swim-up techniqueProcedure or surgery
swim-up technique used
zeta test techniqueProcedure or surgery
zeta test technique used
| Study group | Role | What they receive |
|---|---|---|
| swim-up | Active comparator | swim-up technique for semen processing Receives: Procedure: swim-up technique |
| zeta test | Active comparator | zeta test technique for semen processing Receives: Procedure: zeta test technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: after taking semen sample by 30 minutes
Secondary outcomes (1)
reproductive success
by measuring HCG in the patient seruum
Measured: pregnancy test done 15 days after the embryo transfer.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startApr 2014
- Primary completionApr 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assisted Reproductive TechnologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- khalid abd aziz mohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, khalid abd aziz mohamed, Benha University
- Investigators
- wagdy amer, MD, Principal investigator, lecturerabo baker el nashar, MD, Study chair, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02520869
- Sponsor's protocol ID
- wagdy 1
- Status last verified
- Sep 2016
- First submitted
- 4 Aug 2015
- Last updated
- 20 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Sperm DNA Fragmentation and Sperm Morphology for Predicting Outcome of Assisted Reproduction Treatment
- ClinicalTrials.gov ID
- NCT02520869
- Acronym / sponsor ID
- wagdy 1
- Conditions
- Assisted Reproductive Technology
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- khalid abd aziz mohamedUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Apr 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This study will be carried out in private centers for IVF. The aim of this study is to determine the prognostic value of sperm DNA fragmentation levels before and after semen processing and sperm morphology in predicting the outcome of assisted reproduction.
60 couples will undergo ICSI cycles in private centers for IVF. All patients will go through an ICSI cycle. Monitoring: COH 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 more than 8mm, both the gonadotropin and agonist injections will be stopped and 10,000 IU of hCG 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 intramuscularly 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.
DNA fragmentation assay:
The assessment of DNA damage will be measured before and after processing for each sample using an improved version of the sperm chromatin dispersion test. Samples will be prepared for analysis. staining step will be required to evaluate the prepared slides. The samples will be stained with Diff-Quik solution, immersing each slide in Diff-Quik solution I (eosinophilic) and Diff-Quik solution II (basophilic) for 6 min each, allowed to dry at room temperature .then the slide will be examined under bright field microscope.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| swim-up | Active comparator | Procedure: swim-up techniqueswim-up technique for semen processing |
| zeta test | Active comparator | Procedure: zeta test techniquezeta test technique for semen processing |
Who may qualify
- Ages
- 19 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| swim-up techniqueswim-up technique used | Procedure or surgery | swim-up |
| zeta test techniquezeta test technique used | Procedure or surgery | zeta test |
Primary outcome
Percentage of spermatozoa with fragmented DNA before and after processing
Time frame: after taking semen sample by 30 minutes
Semen samples will be collected by masturbation in clean containers, usually after 2-3 days of abstinence
1 secondary outcome
reproductive success
Time frame: pregnancy test done 15 days after the embryo transfer.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
wagdy amer, MD principal investigator
lecturer
abo baker el nashar, MD study chair
professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing swim-up technique and zeta test technique in people with Assisted Reproductive Technology, run by khalid abd aziz mohamed at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of spermatozoa with fragmented DNA before and after processing (time frame: after taking semen sample by 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2016.