Unexplained InfertilityNCT03355937
Using Microfluidic Separation Sperm Selection for Unexplained Infertility and Reccurrent Implantation Failure
A study testing Sperm Chip in people with Unexplained Infertility and Recurrent Implantation Failure, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
In order to increase the likelihood of achieving IVF-treated pregnancy, good quality embryo transfer is important. To get good quality embryos, good quality gametes are needed. The selection of sperm is regulated according to the changing and mobility characteristics of today's conditions. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Unexplained Infertility, Recurrent Implantation Failure
- What is being tested?
- Sperm Chip
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 31 Dec 2019
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Unexplained Infertility Group; The inclusion criteria are;
- normal HSG,
- normal hormone levels,
- normal over functions,
- having normal uterine cavity and endometrial thickness determined by office hysteroscopy
- no endometriosis (determined by transvaginal ultrasonography and / or diagnostic laparoscopy)
- normal spermiogram result Recurrent Implantation Failure The inclusion criteria are;
1-The inclusion criteria of the working group are: 2-Failure of embryo transfer at least twice after high quality embryo transfer after 3-IVF treatment, 4-having normal hormone reserve (FSH <8 mIU / mL), 5-respond well to hormone stimulation (> 8 oocyte collection), 6-having normal uterine cavity and endometrial thickness determined by office hysteroscopy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Acibadem Fulya Hospital
Istanbul, Besiktas, 34349
Murat Dogan, 005056139577, muratdogan1984@gmail.com
Murat Dogan
About this study
Official title: The Effects of Using Microfluidic Separation Sperm Selection for Unexplained Infertility(UEI) and Reccurrent Implantation Failure(RIF)
In order to increase the likelihood of achieving IVF-treated pregnancy, good quality embryo transfer is important. To get good quality embryos, good quality gametes are needed. The selection of sperm is regulated according to the changing and mobility characteristics of today's conditions. The choice of multi-fluid sperm is thought to provide better sperm to obtain the environment in physiological conditions. Better embryo transfer to achieve better sperm elongation will increase the likelihood of pregnancy.
Read the detailed description
Patients will be treated with conventional IVF treatment. A vaginal ultrasound (US) examination will be perform on day 3 of the cycle for assessment of ovarian size and to exclude patients with large ovarian cysts. If a cyst >20 mm is present, the cycle will cancel. At an initial dose of 225 IU, hMG will be given daily by IM injection commencing on day 3 of the cycle. The dose will be adjusted as re- quired depending on the E2 (estradiol) level. Daily endovaginal US examinations for follicle growth assessment will be started when the E2 level reached 275 pg/mL (1,000 pmoljL). When at least two follicles would reach 18 mm in diameter, 5,000 IU of hCG will be administered intramuscularly. Oocyte retrieval will be performed vaginally under US guidance 36 hours later. Sperm for ICSI procedure of oocytes will be prepared by a standard swim-up technique using for control group and sperm chip method will be used for study group for Unexplained Infertility and Recurrent Implantation Failure group. Uterine transfer of embryos will be carry out fifth day after oocyte retrieval using a catheter.
- Being tested
- Sperm Chip
- Keywords
- unexplained infertility, recurrent implantation failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sperm ChipProcedure or surgery
Sperm selection using by conventional or with sperm chip
| Study group | Role | What they receive |
|---|---|---|
| UEI Sperm Chip (-) | Active comparator | Conventional IVF treatment and using conventional sperm selection Receives: Procedure: Sperm Chip |
| UEI Sperm Chip (+) | Experimental | Conventional IVF treatment and using sperm chip for sperm selection Receives: Procedure: Sperm Chip |
| RIF sperm chip (-) | Active comparator | Conventional IVF treatment and using conventional sperm selection Receives: Procedure: Sperm Chip |
| RIF sperm chip (+) | Experimental | Conventional IVF treatment and using sperm chip for sperm selection Receives: Procedure: Sperm Chip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Pregnancy Rate
Clinical pregnancy includes intrauterine gestation (pres- ence of a gestational sac on ultrasonography), ectopic preg- nancy, and miscarriage diagnosed by histology.Cycles with only a positive pregnancy test (biochemical pregnancy) are not considered to have a clinical pregnancy.
Measured: 36 month
Live Birth Rate
A delivery is the birth of one or more infants, either living or not, after 20 weeks of gestation. A live birth is a delivery that results in at least one living infant
Measured: 36 month
Abortion Rate
Pregnancy loss includes miscarriage and therapeutic abor- tion of a clinical intrauterine pregnancy occurring at %20 weeks of gestation.
Measured: 36 month
Implantation Rate
Implantation rate is the number of gestational sacs observed on ultrasonog- raphy, divided by the number of embryos transferred.
Measured: 36 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start1 Jan 2018 (estimated)
- Primary completion30 Jun 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
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 Unexplained 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Dogan, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03355937
- Sponsor's protocol ID
- Ob&Gyn Fulya
- Status last verified
- Nov 2017
- First submitted
- 15 Nov 2017
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tasoglu S, Safaee H, Zhang X, Kingsley JL, Catalano PN, Gurkan UA, Nureddin A, Kayaalp E, Anchan RM, Maas RL, Tuzel E, Demirci U. Exhaustion of racing sperm in nature-mimicking microfluidic channels during sorting. Small. 2013 Oct 25;9(20):3374-84. doi: 10.1002/smll.201300020. Epub 2013 May 16.
PubMed 23677651
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Using Microfluidic Separation Sperm Selection for Unexplained Infertility(UEI) and Reccurrent Implantation Failure(RIF)
- ClinicalTrials.gov ID
- NCT03355937
- Acronym / sponsor ID
- Ob&Gyn Fulya
- Keywords
- unexplained infertility, recurrent implantation failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 29 Nov 2017 (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.
In order to increase the likelihood of achieving IVF-treated pregnancy, good quality embryo transfer is important. To get good quality embryos, good quality gametes are needed. The selection of sperm is regulated according to the changing and mobility characteristics of today's conditions. The choice of multi-fluid sperm is thought to provide better sperm to obtain the environment in physiological conditions. Better embryo transfer to achieve better sperm elongation will increase the likelihood of pregnancy.
Detailed description
Patients will be treated with conventional IVF treatment. A vaginal ultrasound (US) examination will be perform on day 3 of the cycle for assessment of ovarian size and to exclude patients with large ovarian cysts. If a cyst >20 mm is present, the cycle will cancel. At an initial dose of 225 IU, hMG will be given daily by IM injection commencing on day 3 of the cycle. The dose will be adjusted as re- quired depending on the E2 (estradiol) level. Daily endovaginal US examinations for follicle growth assessment will be started when the E2 level reached 275 pg/mL (1,000 pmoljL). When at least two follicles would reach 18 mm in diameter, 5,000 IU of hCG will be administered intramuscularly. Oocyte retrieval will be performed vaginally under US guidance 36 hours later. Sperm for ICSI procedure of oocytes will be prepared by a standard swim-up technique using for control group and sperm chip method will be used for study group for Unexplained Infertility and Recurrent Implantation Failure group. Uterine transfer of embryos will be carry out fifth day after oocyte retrieval using a catheter.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| UEI Sperm Chip (-) | Active comparator | Procedure: Sperm ChipConventional IVF treatment and using conventional sperm selection |
| UEI Sperm Chip (+) | Experimental | Procedure: Sperm ChipConventional IVF treatment and using sperm chip for sperm selection |
| RIF sperm chip (-) | Active comparator | Procedure: Sperm ChipConventional IVF treatment and using conventional sperm selection |
| RIF sperm chip (+) | Experimental | Procedure: Sperm ChipConventional IVF treatment and using sperm chip for sperm selection |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Sperm ChipSperm selection using by conventional or with sperm chip | Procedure or surgery | RIF sperm chip (+), RIF sperm chip (-), UEI Sperm Chip (+), UEI Sperm Chip (-) |
Primary outcome
Clinical Pregnancy Rate
Time frame: 36 month
Clinical pregnancy includes intrauterine gestation (pres- ence of a gestational sac on ultrasonography), ectopic preg- nancy, and miscarriage diagnosed by histology.Cycles with only a positive pregnancy test (biochemical pregnancy) are not considered to have a clinical pregnancy.
Live Birth Rate
Time frame: 36 month
A delivery is the birth of one or more infants, either living or not, after 20 weeks of gestation. A live birth is a delivery that results in at least one living infant
Abortion Rate
Time frame: 36 month
Pregnancy loss includes miscarriage and therapeutic abor- tion of a clinical intrauterine pregnancy occurring at %20 weeks of gestation.
Implantation Rate
Time frame: 36 month
Implantation rate is the number of gestational sacs observed on ultrasonog- raphy, divided by the number of embryos transferred.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2017.
- Results publication: PubMed 23677651Tasoglu S, Safaee H, Zhang X, Kingsley JL, Catalano PN, Gurkan UA, Nureddin A, Kayaalp E, Anchan RM, Maas RL, Tuzel E, Demirci U. Exhaustion of racing sperm in nature-mimicking microfluidic channels during sorting. Small. 2013 Oct 25;9(20):3374-84. doi: 10.1002/smll.201300020. Epub 2013 May 16.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sperm Chip in people with Unexplained Infertility and Recurrent Implantation Failure, run by Acibadem University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 29 Nov 2017. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Murat Dogan (00905056139577, muratdogan1984@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Pregnancy Rate (time frame: 36 month). The study lists 4 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 NCT03355937, 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 29 Nov 2017.