Infertility, MaleNCT04482517
Reproductive Outcomes of Different Sperm Selection Techniques for ICSI Patients With Abnormal Sperm DNA Fragmentation.
A study testing Density Gradient Centrifugation, Physiological ICSI and Magnetic activated cell sorting in people with Infertility, Male, run by Ganin Fertility Center at 1 site in Egypt.
Trial summary
Comparing the reproductive outcomes of different sperm selection techniques; Density gradient centrifugation (DGC), Testicular sperm (Testi), Physiological ICSI (PICSI), and Magnetic activated cell sorting (MACS) in abnormal sperm DNA fragmentation (SDF) ICSI patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Infertility, Male
- What is being tested?
- Density Gradient Centrifugation, Physiological ICSI and Magnetic activated cell sorting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2017to 1 Dec 2018
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Female age was ≤37 years
- Female should has 5≥ metaphase II oocytes
- Males having abnormal SDF levels ≥ 20.3% by TUNEL assay
- Abstinence from 1 to 2 days
- Males having at least 1 million total motile progressive count
Who cannot join
- Leukocytospermia
- Presence of varicocele.
- Known genetic abnormality
- Use of sperm donation or cryopreserved sperm
- Use of Oocyte donation
- Use of gestational carrier
- Presence of any of the endometrial factors that affect embryo implantation such as hydrosalpings, adenomyosis or previous uterine infection
- Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reproductive Outcomes of Different Sperm Selection Techniques; Density Gradient Centrifugation, Testicular Sperm, PICSI, and MACS for ICSI Patients With Abnormal Sperm DNA Fragmentation
Comparing the reproductive outcomes of different sperm selection techniques; Density gradient centrifugation (DGC), Testicular sperm (Testi), Physiological ICSI (PICSI), and Magnetic activated cell sorting (MACS) in abnormal sperm DNA fragmentation (SDF) ICSI patients.
- Conditions
- Infertility, Male
- Being tested
- Density Gradient Centrifugation, Physiological ICSI, Magnetic activated cell sorting, Testicular sperm
- Keywords
- Sperm DNA fragmentation, PICSI, MACS, Sperm Selection, DGC
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Density Gradient CentrifugationOther
Also called DGC
Semen processing is done by double layer density gradient method.
Physiological ICSIOther
Also called PICSI
Sperm selection by PICSI dishes depending on hyaluronan binding of sperm head
Magnetic activated cell sortingOther
Also called MACS
Sperm selection by using Annexin V micro-beads and separation columns
Testicular spermOther
Also called Testi
Using testicular sperm retrieved by TESA or TESE
| Study group | Role | What they receive |
|---|---|---|
| Density Gradient Centrifugation (DGC) | Other | Using the routine DGC sperm processing only Receives: Other: Density Gradient Centrifugation |
| Physiological ICSI (PICSI) | Active comparator | Using PICSI dish for selecting sperm with lower sperm DNA fragmentation Receives: Other: Physiological ICSI |
| Magnetic Activated Cell Sorting (MACS) | Active comparator | Using MACS for selecting sperm with lower sperm DNA fragmentation Receives: Other: Magnetic activated cell sorting |
| Testicular sperm (Testi) | Active comparator | Using testicular sperm not ejaculated sperm Receives: Other: Testicular sperm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Defined as clinical pregnancy per transfer
Measured: 14 days following embryo transfer
Implantation rate
Defined as number of gestational sacs with fetal heart beat, shown by ultrasound in gestational week 6 over number of embryo transferred.
Measured: 6- 8 weeks following embryo transfer
Ongoing pregnancy rate
Defined as the proportion of pregnancies that completed more than 20 weeks of gestation
Measured: 20 weeks of gestation
Secondary outcomes (4)
Cleavage rate
Defined as the proportion of cleaved embryos on day 3 over the injected oocytes
Measured: 3 days
Blastulation rate
Defined as the proportion of blastocysts formed on day 5 or 6 over the cleaved embryos on day 3
Measured: 5-6 days
High quality blastocyst rate
Defined as the assessment of blastocyst quality according to Gardner's criteria into: good, fair or bad in terms of percentage of the total formed blastocysts
Measured: 5-6 days
Miscarriage rate
Defined as the proportion of miscarried cases
Measured: 20 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start1 Mar 2017
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infertility, MaleStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ganin Fertility Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eman Hasanen, Principal investigator, Ganin Fertility Centerkhaled Elqusi, Principal investigator, Ganin Fertility CenterSalma Eltanbouly, Principal investigator, Ganin Fertility CenterSamar Gamal, Principal investigator, Ganin Fertility CenterAbd ElGhafar Hussin, Principal investigator, Ganin Fertility CenterHanaa Elkhadr, Principal investigator, Ganin Fertility CenterHosam Zaki, Study chair, Ganin Fertility Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04482517
- Sponsor's protocol ID
- MH-005
- Status last verified
- Jul 2020
- First submitted
- 18 Jul 2020
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hozyen M, Hasanen E, Elqusi K, ElTanbouly S, Gamal S, Hussin AG, AlKhader H, Zaki H. Reproductive Outcomes of Different Sperm Selection Techniques for ICSI Patients with Abnormal Sperm DNA Fragmentation: a Randomized Controlled Trial. Reprod Sci. 2022 Jan;29(1):220-228. doi: 10.1007/s43032-021-00642-y. Epub 2021 Jun 2.
PubMed 34076869
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproductive Outcomes of Different Sperm Selection Techniques; Density Gradient Centrifugation, Testicular Sperm, PICSI, and MACS for ICSI Patients With Abnormal Sperm DNA Fragmentation
- ClinicalTrials.gov ID
- NCT04482517
- Acronym / sponsor ID
- MH-005
- Conditions
- Infertility, Male
- Keywords
- Sperm DNA fragmentation, PICSI, MACS, Sperm Selection, DGC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Ganin Fertility CenterUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 22 Jul 2020 (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.
Comparing the reproductive outcomes of different sperm selection techniques; Density gradient centrifugation (DGC), Testicular sperm (Testi), Physiological ICSI (PICSI), and Magnetic activated cell sorting (MACS) in abnormal sperm DNA fragmentation (SDF) ICSI patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Density Gradient Centrifugation (DGC) | Other | Other: Density Gradient CentrifugationUsing the routine DGC sperm processing only |
| Physiological ICSI (PICSI) | Active comparator | Other: Physiological ICSIUsing PICSI dish for selecting sperm with lower sperm DNA fragmentation |
| Magnetic Activated Cell Sorting (MACS) | Active comparator | Other: Magnetic activated cell sortingUsing MACS for selecting sperm with lower sperm DNA fragmentation |
| Testicular sperm (Testi) | Active comparator | Other: Testicular spermUsing testicular sperm not ejaculated sperm |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female age was ≤37 years
- Female should has 5≥ metaphase II oocytes
- Males having abnormal SDF levels ≥ 20.3% by TUNEL assay
- Abstinence from 1 to 2 days
- Males having at least 1 million total motile progressive count
Key exclusion criteria (8 listed)
- Leukocytospermia
- Presence of varicocele.
- Known genetic abnormality
- Use of sperm donation or cryopreserved sperm
- Use of Oocyte 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 |
|---|---|---|
| Density Gradient CentrifugationAlso: DGCSemen processing is done by double layer density gradient method. | Other | Density Gradient Centrifugation (DGC) |
| Physiological ICSIAlso: PICSISperm selection by PICSI dishes depending on hyaluronan binding of sperm head | Other | Physiological ICSI (PICSI) |
| Magnetic activated cell sortingAlso: MACSSperm selection by using Annexin V micro-beads and separation columns | Other | Magnetic Activated Cell Sorting (MACS) |
| Testicular spermAlso: TestiUsing testicular sperm retrieved by TESA or TESE | Other | Testicular sperm (Testi) |
Primary outcome
Clinical pregnancy rate
Time frame: 14 days following embryo transfer
Defined as clinical pregnancy per transfer
Implantation rate
Time frame: 6- 8 weeks following embryo transfer
Defined as number of gestational sacs with fetal heart beat, shown by ultrasound in gestational week 6 over number of embryo transferred.
Ongoing pregnancy rate
Time frame: 20 weeks of gestation
Defined as the proportion of pregnancies that completed more than 20 weeks of gestation
4 secondary outcomes
Cleavage rate
Time frame: 3 days
Blastulation rate
Time frame: 5-6 days
High quality blastocyst rate
Time frame: 5-6 days
Miscarriage rate
Time frame: 20 weeks of gestation
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 22 Jul 2020.
- Derived from this study: PubMed 34076869Hozyen M, Hasanen E, Elqusi K, ElTanbouly S, Gamal S, Hussin AG, AlKhader H, Zaki H. Reproductive Outcomes of Different Sperm Selection Techniques for ICSI Patients with Abnormal Sperm DNA Fragmentation: a Randomized Controlled Trial. Reprod Sci. 2022 Jan;29(1):220-228. doi: 10.1007/s43032-021-00642-y. Epub 2021 Jun 2.
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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.
Eman Hasanen principal investigator
Ganin Fertility Center
khaled Elqusi principal investigator
Ganin Fertility Center
Salma Eltanbouly principal investigator
Ganin Fertility Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Density Gradient Centrifugation, Physiological ICSI and Magnetic activated cell sorting in people with Infertility, Male, 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 5 inclusion and 8 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 22 Jul 2020. 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?
Clinical pregnancy rate (time frame: 14 days following embryo transfer). The study lists 3 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 NCT04482517, which also lists 1 linked publication.
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 22 Jul 2020.