Female Urogenital DiseasesNCT01765322
The Effect of Laser-assisted Zona Thinning on the Implantation Rate in the Women of Advanced Age
A study testing ZILOS-TK IVOS Analyzer in people with Female Urogenital Diseases, run by Shanxi Provincial Maternity and Children's Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine whether laser-assisted zona thinning improve the implantation rate of the women of advanced age in the first IVF/ICSI cycles Read more about this study
- Who is it for?
- Ages 35 to 46 years, women only
- Conditions the study is for
- Female Urogenital Diseases
- What is being tested?
- ZILOS-TK IVOS Analyzer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Nov 2013to Jul 2015
- 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 35 to 46 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age: 35y ≤age≤46y
- Basal FSH value: FSH≤10IU/L
- Day-3 embryos transferred in the fresh IVF/ICSI cycles
- the number of embryos available to be transferred on Day-3: ≥one embryo
Who cannot join
- cycles with thawed/warmed embryos biopsied for PGD/PGS.
- cycles with oocyte donation transfer.
- the maximum number of previous unsuccessful IVF attempts: ≥ 3 cycles(transfer cycles)
- any cycles with the risk of OHSS, fluid in the uterine cavity, abnormal endometrium, uterine abnormalities,pelvic inflammation, and other acute maternal problems.
- One or both spouses have an abnormal karyotype (including polymorphism)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Maternal and Children Health Care Hospital
Xi'an, Shaanxi, 710003
Wenhao Shi, Master, +86-029-87219120, swihao@yahoo.com
About this study
Official title: Center of Assisted Reproductive Technology
The purpose of this study is to determine whether laser-assisted zona thinning improve the implantation rate of the women of advanced age in the first IVF/ICSI cycles
Read the detailed description
Registry procedures：
- It's required to sign an informed consent form prior to the recruitment of all patients.
- Data collection and entry need double check and supervision.
The outcome measures:
the implantation rate per embryo transfer miscarriage live birth
- Conditions
- Female Urogenital Diseases
- Being tested
- ZILOS-TK IVOS Analyzer
- Medical subject headings
- Female Urogenital Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZILOS-TK IVOS AnalyzerDevice
The subjects are going to participate the treatment of assisted hatching in vitro fertilization by Zona Infrared Laser Optical System (ZILOS-TK,Hamilton Thorne Biosciences,USA)
| Study group | Role | What they receive |
|---|---|---|
| Assisted hatching group (AH group) | Experimental | The subjects are going to participate the treatment of assisted hatching in vitro fertilization by Zona Infrared Laser Optical System (ZILOS-TK IVOS Analyzer,Hamilton Thorne Biosciences,USA). Receives: Device: ZILOS-TK IVOS Analyzer |
| Control group | No intervention | The subjects are going to undergo the same procedure except for the treatment of assisted hatching. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The implantation rate
the implantation rate per embryo in first fresh embryos transfer cycles
Measured: 30 days
Secondary outcomes (1)
The miscarriage
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study startNov 2013
- Primary completionJan 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Urogenital DiseasesStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanxi Provincial Maternity and Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shi Wenhao, Shanxi Provincial Maternity and Children's Hospital
- Investigators
- Wenhao Shi, Master, Study director, Maternal and Children Health Care Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01765322
- Sponsor's protocol ID
- MCHC-2013-01
- Status last verified
- Nov 2013
- First submitted
- 9 Jan 2013
- Last updated
- 27 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Center of Assisted Reproductive Technology
- ClinicalTrials.gov ID
- NCT01765322
- Acronym / sponsor ID
- MCHC-2013-01
- Conditions
- Female Urogenital Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Shanxi Provincial Maternity and Children's HospitalUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 10 Jan 2013 (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 purpose of this study is to determine whether laser-assisted zona thinning improve the implantation rate of the women of advanced age in the first IVF/ICSI cycles
Detailed description
Registry procedures：
- It's required to sign an informed consent form prior to the recruitment of all patients.
- Data collection and entry need double check and supervision.
The outcome measures:
the implantation rate per embryo transfer miscarriage live birth
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Assisted hatching group (AH group) | Experimental | Device: ZILOS-TK IVOS AnalyzerThe subjects are going to participate the treatment of assisted hatching in vitro fertilization by Zona Infrared Laser Optical System (ZILOS-TK IVOS Analyzer,Hamilton Thorne Biosciences,USA). |
| Control group | No intervention | –The subjects are going to undergo the same procedure except for the treatment of assisted hatching. |
Who may qualify
- Ages
- 35 to 46 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: 35y ≤age≤46y
- Basal FSH value: FSH≤10IU/L
- Day-3 embryos transferred in the fresh IVF/ICSI cycles
- the number of embryos available to be transferred on Day-3: ≥one embryo
Key exclusion criteria (5 listed)
- cycles with thawed/warmed embryos biopsied for PGD/PGS.
- cycles with oocyte donation transfer.
- the maximum number of previous unsuccessful IVF attempts: ≥ 3 cycles(transfer cycles)
- any cycles with the risk of OHSS, fluid in the uterine cavity, abnormal endometrium, uterine abnormalities,pelvic inflammation, and other acute maternal problems.
- One or both spouses have an abnormal karyotype (including polymorphism)
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 |
|---|---|---|
| ZILOS-TK IVOS AnalyzerThe subjects are going to participate the treatment of assisted hatching in vitro fertilization by Zona Infrared Laser Optical System (ZILOS-TK,Hamilton Thorne Biosciences,USA) | Device | Assisted hatching group (AH group) |
Primary outcome
The implantation rate
Time frame: 30 days
the implantation rate per embryo in first fresh embryos transfer cycles
1 secondary outcome
The miscarriage
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2013.
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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.
Wenhao Shi, Master study director
Maternal and Children Health Care Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ZILOS-TK IVOS Analyzer in people with Female Urogenital Diseases, run by Shanxi Provincial Maternity and Children's Hospital at 1 site in China.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 27 Nov 2013. 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 China. 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 Juanzi Shi, Doctor (+86-029-87219120, shijuanzi123@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The implantation rate (time frame: 30 days). 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 27 Nov 2013.