BlastocystNCT04144621
Sperm DNA Fragmentation Effects on Blastocyst Morphology Grading, Pregnancy Rate and Implantation Rate
An observational study of Blastocyst and Implantation Rate, run by Ganin Fertility Center at 1 site in Egypt.
Trial summary
Retrospective cohort study for 189 couples assigned to normal and abnormal Sperm DNA fragmentation (SDF) groups.To determine the effect of SDF on blastocyst's trophectoderm (TE), Inner cell mass (ICM) morphology grading, and implantation rate. Semen in both groups was processed by density gradient (DG). Read more about this study
- Who is it for?
- Ages Up to 37 years
- Conditions the study is for
- Blastocyst, Implantation Rate
- What is being tested?
- ICSI
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 189 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 1 Apr 2019
- Phase
- Observational
- 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 Up to 37 years
- All sexes
- Child, Adult
Study population: ICSI patients in Ganin Fertility Center from January 2018 to September 2018.
Who may be able to join
- All cases in this study have to reach the blastocyst stage.
- Female age ≤37 years old.
- Male sperm count ≥ 5 million.
Who cannot join
- Usage of sperm selection techniques.
- Testicular aspiration or testicular biopsies.
- Oocyte or sperm donation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Correlation of Sperm DNA Fragmentation With Blastocyst Grading and Its Implantation Potential
Retrospective cohort study for 189 couples assigned to normal and abnormal Sperm DNA fragmentation (SDF) groups.To determine the effect of SDF on blastocyst's trophectoderm (TE), Inner cell mass (ICM) morphology grading, and implantation rate. Semen in both groups was processed by density gradient (DG).
Read the detailed description
Purpose: to determine if sperm DNA fragmentation (SDF) has a correlation with Blastocyst's trophectoderm (TE) and Inner cell mass (ICM) grading, or with the implantation rate?
Method: Retrospective cohort study for 189 couples, assigned to normal SDF group (121 cases), and abnormal SDF group (68 cases). Semen in both groups was processed by double layer density gradient (DG).
Statistical analysis done using SPSS version 22.
- Conditions
- Blastocyst, Implantation Rate
- Being tested
- ICSI
- Keywords
- Sperm DNA fragmentation, Implantation rate, Pregnancy rate, Blastocyst grading
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICSIProcedure or surgery
Intracytoplasmic sperm injection of female partner oocytes with ejaculated sperm selected by density gradient centrifugation
| Study group | Role | What they receive |
|---|---|---|
| Normal SDF | Couples with male partners having SDF lower than 20% using TUNEL assay Receives: Procedure: ICSI | |
| Abnormal SDF | Couples with male partners having SDF greater than 20% using TUNEL assay Receives: Procedure: ICSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blastocyst morphological grading
Morphological grading of trophectoderm and Inner cell mass using Gardner's criteria 1999, from grade A to C ( A is the highest quality).
Measured: 5-6 days after ICSI
Implantation rate
Percentage of the implanted embryos number for each group / number of transferred embryos.
Measured: 6 weeks of pregnancy
Secondary outcomes (3)
Fertilization rate
Percentage of fertilized oocyte (appearance of two pronuclei) / Number of injected oocytes
Measured: 16-19 hours of ICSI
Blastulation rate
Percentage of total blastocysts / total 2PN
Measured: 5-6 days of ICSI
Pregnancy rate
Percentage of pregnant cases / transferred cases for each group ( positive pregnancy test)
Measured: After 2 weeks of embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start1 Jan 2018
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BlastocystStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ganin Fertility Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manar Hozyen, MSc, Principal investigator, Ganin Fertility CenterEman Hassanen, BSc, Principal investigator, Ganin Fertility CenterHosam Zaki, MSc, FRCOG, Study chair, Ganin Fertility CenterHanaa El Khedr, Principal investigator, Ganin Fertility CenterYasmine Azzouz, BSc, Principal investigator, Ganin Fertility Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04144621
- Sponsor's protocol ID
- MH0001
- Status last verified
- Oct 2019
- First submitted
- 28 Oct 2019
- Last updated
- 1 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wdowiak A, Bojar I. Relationship between pregnancy, embryo development, and sperm deoxyribonucleic acid fragmentation dynamics. Saudi J Biol Sci. 2016 Sep;23(5):598-606. doi: 10.1016/j.sjbs.2015.08.001. Epub 2015 Aug 10.
PubMed 27579009Gat I, Tang K, Quach K, Kuznyetsov V, Antes R, Filice M, Zohni K, Librach C. Sperm DNA fragmentation index does not correlate with blastocyst aneuploidy or morphological grading. PLoS One. 2017 Jun 7;12(6):e0179002. doi: 10.1371/journal.pone.0179002. eCollection 2017.
PubMed 28591199Alvarez Sedo C, Bilinski M, Lorenzi D, Uriondo H, Noblia F, Longobucco V, Lagar EV, Nodar F. Effect of sperm DNA fragmentation on embryo development: clinical and biological aspects. JBRA Assist Reprod. 2017 Dec 1;21(4):343-350. doi: 10.5935/1518-0557.20170061.
PubMed 29116706
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation of Sperm DNA Fragmentation With Blastocyst Grading and Its Implantation Potential
- ClinicalTrials.gov ID
- NCT04144621
- Acronym / sponsor ID
- MH0001
- Conditions
- Blastocyst, Implantation Rate
- Keywords
- Sperm DNA fragmentation, Implantation rate, Pregnancy rate, Blastocyst grading
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Ganin Fertility CenterUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 30 Oct 2019 (actual)
- 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.
Retrospective cohort study for 189 couples assigned to normal and abnormal Sperm DNA fragmentation (SDF) groups.To determine the effect of SDF on blastocyst's trophectoderm (TE), Inner cell mass (ICM) morphology grading, and implantation rate. Semen in both groups was processed by density gradient (DG).
Detailed description
Purpose: to determine if sperm DNA fragmentation (SDF) has a correlation with Blastocyst's trophectoderm (TE) and Inner cell mass (ICM) grading, or with the implantation rate?
Method: Retrospective cohort study for 189 couples, assigned to normal SDF group (121 cases), and abnormal SDF group (68 cases). Semen in both groups was processed by double layer density gradient (DG).
Statistical analysis done using SPSS version 22.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal SDF | – | Procedure: ICSICouples with male partners having SDF lower than 20% using TUNEL assay |
| Abnormal SDF | – | Procedure: ICSICouples with male partners having SDF greater than 20% using TUNEL assay |
Who may qualify
- Ages
- Up to 37 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- ICSI patients in Ganin Fertility Center from January 2018 to September 2018.
Key inclusion criteria (3 listed)
- All cases in this study have to reach the blastocyst stage.
- Female age ≤37 years old.
- Male sperm count ≥ 5 million.
Key exclusion criteria (3 listed)
- Usage of sperm selection techniques.
- Testicular aspiration or testicular biopsies.
- Oocyte or sperm donation.
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 |
|---|---|---|
| ICSIIntracytoplasmic sperm injection of female partner oocytes with ejaculated sperm selected by density gradient centrifugation | Procedure or surgery | Abnormal SDF, Normal SDF |
Primary outcome
Blastocyst morphological grading
Time frame: 5-6 days after ICSI
Morphological grading of trophectoderm and Inner cell mass using Gardner's criteria 1999, from grade A to C ( A is the highest quality).
Implantation rate
Time frame: 6 weeks of pregnancy
Percentage of the implanted embryos number for each group / number of transferred embryos.
3 secondary outcomes
Fertilization rate
Time frame: 16-19 hours of ICSI
Blastulation rate
Time frame: 5-6 days of ICSI
Pregnancy rate
Time frame: After 2 weeks of embryo transfer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
- Background: PubMed 27579009Wdowiak A, Bojar I. Relationship between pregnancy, embryo development, and sperm deoxyribonucleic acid fragmentation dynamics. Saudi J Biol Sci. 2016 Sep;23(5):598-606. doi: 10.1016/j.sjbs.2015.08.001. Epub 2015 Aug 10.
- Background: PubMed 28591199Gat I, Tang K, Quach K, Kuznyetsov V, Antes R, Filice M, Zohni K, Librach C. Sperm DNA fragmentation index does not correlate with blastocyst aneuploidy or morphological grading. PLoS One. 2017 Jun 7;12(6):e0179002. doi: 10.1371/journal.pone.0179002. eCollection 2017.
- Background: PubMed 29116706Alvarez Sedo C, Bilinski M, Lorenzi D, Uriondo H, Noblia F, Longobucco V, Lagar EV, Nodar F. Effect of sperm DNA fragmentation on embryo development: clinical and biological aspects. JBRA Assist Reprod. 2017 Dec 1;21(4):343-350. doi: 10.5935/1518-0557.20170061.
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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.
Manar Hozyen, MSc principal investigator
Ganin Fertility Center
Eman Hassanen, BSc principal investigator
Ganin Fertility Center
Hosam Zaki, MSc, FRCOG study chair
Ganin Fertility Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blastocyst and Implantation Rate, run by Ganin Fertility Center 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 1 Nov 2019. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Blastocyst morphological grading (time frame: 5-6 days after ICSI). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04144621, which also lists 3 linked publications.
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 1 Nov 2019.