InfertilityNCT02328534
Semen Processing for ICSI Using Swim-down and Density Gradient Methods
An observational study of Infertility, run by Ahmad Mustafa Mohamed Metwalley at 2 sites in 2 countries.
Trial summary
The investigators evaluate the feedback of using swim down semen processing method during preparation for ICSI and compare the results of pregnancy and embryos quality with the cases used density gradient method for their semen processing. Read more about this study
- Who is it for?
- Ages 20 to 38 years
- Conditions the study is for
- Infertility
- What is being tested?
- Blastocyst Formation Rate, Blastocyst Rate and Pregnancy Rate
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 890 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2007to Jan 2014
- 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 20 to 38 years
- All sexes
- No healthy volunteers
- Adult
Study population: Cases collected were submitted for ART treatment using ICSI/IVF procedures. In two different IVF clinics at Manama-Bahrain and Sohag-Egypt. The groups of about 890 couple prepared for treatment.
Who may be able to join
None listed.
Who cannot join
- Cases have semen examination criteria with motility less than 5%
- Cases have semen examination criteria with count less than 1.0 million
- Cases with TESE, TESA and EPSA, both fresh and frozen
- Cases produced less than 4 mature oocytes (M2)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Egypt1 site
Ibn Sina IVF Center- Ibn Sina Hospital
Sohag, Sohag Governorate, 15006
About this study
Official title: Novel Approach of Semen Preparation to Improve ICSI Outcome.
The investigators evaluate the feedback of using swim down semen processing method during preparation for ICSI and compare the results of pregnancy and embryos quality with the cases used density gradient method for their semen processing.
Read the detailed description
There is different semen processing method, in this study we compared the ICSI output when the investigators used one method with higher separation method and minimum sperm stress or physical interface as swimming down using 100 % silica solution, with other more stressful procedure with high selection power as density gradient.
The routine used method as density gradient (DG) includes about 30 min centrifugation at 1200 RPM, and more working steps with more handling procedures. According to many references the investigators can approve that it is method to be indicated with all cases particularly with those severely decreases semen number or motility.
Using 100 % silica solution for semen processing used for ICSi, shews lesser centrifugation time and minimum processing procedures. As swimming down time is about 30 min followed by 5 min washing and finalized with other 3 minutes last wash. For that total interfering physical action is about 8 minutes compared with 30 min with DG method.
In swimming down we are using the natural sperm behavior and own swimming power for separate itself from other seminal components. As well as only the one normally structure and motility direction the only can penetrate the interface surface of silica solution and swim inside higher density matrix using its speed and power.
- Conditions
- Infertility
- Being tested
- Blastocyst Formation Rate, Blastocyst Rate, Pregnancy Rate
- Keywords
- ICSI/IVF, Semen processing, Semen preparation, Swim down, Density gradient, Silica solution
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blastocyst Formation RateBehavioural
Also called Blastocyst developed form cleaved embryos
Embryos developed at Day3 cultures, are continued for Day5 culture tho reach blastocyst stage. The percentage of blastocyst produced from cleaved embryos to be evaluated ar rate.
The evaluation with doe one time using Density Gradient semen one time and Swimming down semen another time.
Blastocyst RateProcedure or surgery
Also called Pregnancey produced formblastocyst embryo transfer
Day 5 embryo transfer achieved pregnancy are compared with total embryo transfer cases at Day5.
The evaluation with doe one time using Density Gradient semen one time and Swimming down semen another time.
Pregnancy confirmed with day 12 after Et and repeated with 48 hours after 1st exam.
Pregnancy RateProcedure or surgery
Also called Pregnancy achieved after all ET
All pregnancy achieved from all ET. Pregnancy confirmed with day 12 after Et and repeated with 48 hours after 1st exam.
The evaluation with doe one time using Density Gradient semen one time and Swimming down semen another time.
| Study group | Role | What they receive |
|---|---|---|
| Density Gradient semen | ICSI Cases processed using DG semen processing and evaluated by
Blastocyst Formation Rate Blastocyst Rate Pregnancy Rate Receives: Behavioral: Blastocyst Formation Rate; Procedure: Blastocyst Rate; Procedure: Pregnancy Rate | |
| Swimming down semen | ICSI Cases processed using SD semen processing and evaluated by
Blastocyst Formation Rate Blastocyst Rate Pregnancy Rate Receives: Behavioral: Blastocyst Formation Rate; Procedure: Blastocyst Rate; Procedure: Pregnancy Rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Pregnancy Rate
Percentage of Pregnancies developed after embryo transfer, for maternal age less than 38 years old.
Measured: 3 Years
Secondary outcomes (2)
Blastulation Rate (BR)
Percentage of blastocyst embryos produced from cleaved embryos, for maternal age less than 38 YO.
Measured: 3 years
Blastocyst formation Rate (BFR)
Developed embryos developed to Blastocyst stage from cleaved embryos.
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startMar 2007
- Primary completionSep 2013
- Study completionJan 2014
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 InfertilityStudies 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
- 890 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmad Mustafa Mohamed Metwalley
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmad Mustafa Mohamed Metwalley, Al Baraka Fertility Hospital
- Investigators
- Ahmad M Metwalley, Ms. Genetics, Study director, Adliyah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02328534
- Sponsor's protocol ID
- AlBarakaSD1
- Status last verified
- Dec 2014
- First submitted
- 28 Dec 2014
- Last updated
- 31 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Malvezzi H, Sharma R, Agarwal A, Abuzenadah AM, Abu-Elmagd M. Sperm quality after density gradient centrifugation with three commercially available media: a controlled trial. Reprod Biol Endocrinol. 2014 Dec 2;12:121. doi: 10.1186/1477-7827-12-121.
PubMed 25466430
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Approach of Semen Preparation to Improve ICSI Outcome.
- ClinicalTrials.gov ID
- NCT02328534
- Acronym / sponsor ID
- AlBarakaSD1
- Conditions
- Infertility
- Keywords
- ICSI/IVF, Semen processing, Semen preparation, Swim down, Density gradient, Silica solution
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 890 participants (actual)
- Lead sponsor
- Ahmad Mustafa Mohamed MetwalleyUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Sep 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 31 Dec 2014 (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.
The investigators evaluate the feedback of using swim down semen processing method during preparation for ICSI and compare the results of pregnancy and embryos quality with the cases used density gradient method for their semen processing.
Detailed description
There is different semen processing method, in this study we compared the ICSI output when the investigators used one method with higher separation method and minimum sperm stress or physical interface as swimming down using 100 % silica solution, with other more stressful procedure with high selection power as density gradient.
The routine used method as density gradient (DG) includes about 30 min centrifugation at 1200 RPM, and more working steps with more handling procedures. According to many references the investigators can approve that it is method to be indicated with all cases particularly with those severely decreases semen number or motility.
Using 100 % silica solution for semen processing used for ICSi, shews lesser centrifugation time and minimum processing procedures. As swimming down time is about 30 min followed by 5 min washing and finalized with other 3 minutes last wash. For that total interfering physical action is about 8 minutes compared with 30 min with DG method.
In swimming down we are using the natural sperm behavior and own swimming power for separate itself from other seminal components. As well as only the one normally structure and motility direction the only can penetrate the interface surface of silica solution and swim inside higher density matrix using its speed and power.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Density Gradient semen | – | Behavioral: Blastocyst Formation Rate, Procedure: Blastocyst Rate, Procedure: Pregnancy RateICSI Cases processed using DG semen processing and evaluated by Blastocyst Formation Rate Blastocyst Rate Pregnancy Rate |
| Swimming down semen | – | Behavioral: Blastocyst Formation Rate, Procedure: Blastocyst Rate, Procedure: Pregnancy RateICSI Cases processed using SD semen processing and evaluated by Blastocyst Formation Rate Blastocyst Rate Pregnancy Rate |
Who may qualify
- Ages
- 20 to 38 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Cases collected were submitted for ART treatment using ICSI/IVF procedures. In two different IVF clinics at Manama-Bahrain and Sohag-Egypt. The groups of about 890 couple prepared for treatment.
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Cases have semen examination criteria with motility less than 5%
- Cases have semen examination criteria with count less than 1.0 million
- Cases with TESE, TESA and EPSA, both fresh and frozen
- Cases produced less than 4 mature oocytes (M2)
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 |
|---|---|---|
| Blastocyst Formation RateAlso: Blastocyst developed form cleaved embryosEmbryos developed at Day3 cultures, are continued for Day5 culture tho reach blastocyst stage. The percentage of blastocyst produced from cleaved embryos to be evaluated ar rate. The evaluation with doe one time using Density Gradient semen one time and Swimming down semen another time. | Behavioural | Density Gradient semen, Swimming down semen |
| Blastocyst RateAlso: Pregnancey produced formblastocyst embryo transferDay 5 embryo transfer achieved pregnancy are compared with total embryo transfer cases at Day5. The evaluation with doe one time using Density Gradient semen one time and Swimming down semen another time. Pregnancy confirmed with day 12 after Et and repeated with 48 hours after 1st exam. | Procedure or surgery | Density Gradient semen, Swimming down semen |
| Pregnancy RateAlso: Pregnancy achieved after all ETAll pregnancy achieved from all ET. Pregnancy confirmed with day 12 after Et and repeated with 48 hours after 1st exam. The evaluation with doe one time using Density Gradient semen one time and Swimming down semen another time. | Procedure or surgery | Density Gradient semen, Swimming down semen |
Primary outcome
Total Pregnancy Rate
Time frame: 3 Years
Percentage of Pregnancies developed after embryo transfer, for maternal age less than 38 years old.
2 secondary outcomes
Blastulation Rate (BR)
Time frame: 3 years
Blastocyst formation Rate (BFR)
Time frame: 3 Years
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 31 Dec 2014.
- Results publication: PubMed 25466430Malvezzi H, Sharma R, Agarwal A, Abuzenadah AM, Abu-Elmagd M. Sperm quality after density gradient centrifugation with three commercially available media: a controlled trial. Reprod Biol Endocrinol. 2014 Dec 2;12:121. doi: 10.1186/1477-7827-12-121.
- Density Gradient procedures descriptionLink provided by the sponsor.
Related trials for Infertility
RecruitingObservational study
Safety and Efficacy of Corifollitropin Alfa N02 Injection in Elderly Women Undergoing Assisted Reproductive Technology (ART)
Infertility
Active, not recruiting
Automation of the In Vitro Fertilization Laboratory
Infertility, ART
RecruitingObservational study
Inherited Reproductive Disorders
Genetic Disorder, Infertility
RecruitingObservational study
Biorepository in Participants Who Undergo OTC for Gonadotoxic Therapy
Acute Ovarian Failure, Infertility
Not yet recruiting
Implementing IVM for Fertility Treatment in Clinical Practice
Infertility
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.
Ahmad M Metwalley, Ms. Genetics study director
Adliyah
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Ahmad Mustafa Mohamed Metwalley at 2 sites in 2 countries.
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 0 inclusion and 4 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 31 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Bahrain, 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?
Total Pregnancy Rate (time frame: 3 Years). 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 NCT02328534, 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 31 Dec 2014.