Infertility, FemaleNCT03103113
The Evolution of Relationship Between Results of Peripheral Blood Test and Outcomes of in Vitro Fertilization
An observational study of Infertility, Female and Immune Tolerance, run by Yeh.
Trial summary
The purpose of this study was to assess the relationship between infertility blood test results and outcomes of pregnancy and alive birth of women who underwent with or without intravenous immunoglobulin (IVIG) before in vitro fertilization. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female, Immune Tolerance
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2012to 31 Dec 2012
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients had underwent infertility blood test and in vitro fertilization treatment in Lee's women hospital
Who may be able to join
- Patients had underwent both infertility blood test and IVF treatment in Lee's women hospital
Who cannot join
- No
About this study
Official title: Division of Infertility, Lee Women's Hospital, Taichung, Taiwan
The purpose of this study was to assess the relationship between infertility blood test results and outcomes of pregnancy and alive birth of women who underwent with or without intravenous immunoglobulin (IVIG) before in vitro fertilization.
Read the detailed description
Study Design (Brief Description)
- Inclusion criteria Patients had underwent infertility blood test or treatment in Lee's women hospital
- Exclusion criteria No
- Endpoint
- Values of blood test (PTT, IDM, ANA, Lupus, protein-s) 2. Embryo quality 3. Results of intravenous immunoglobulin (IVIG) treatment (pregnancy or not) 4. Alive birth rate
- Withdraw criteria and rescue medication No 5. Sample Size and Study Duration Sample Size: total 500 women who underwent IVF treatments and tests from Jan. 2007 to Dec. 2010.
Study Duration: from date of IRB agreement to Dec. 2012 6. Please specify objectives of study when collecting extra specimen from participants No more need to collect extra specimen from participants in this study 7. Expected Endpoints of Treatment No 8. Others No
- Conditions
- Infertility, Female, Immune Tolerance
- Medical subject headings
- Infertility, Female
What is being measured
The primary outcome is the main question the study is designed to answer.
implantation rate
sac and heart bit can be detected after embryo transfer
Measured: 6-8 weaks after last menstrual
Secondary outcomes (1)
live birth rate
live birth after IVF treatment
Measured: live birth after pregnant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start30 Apr 2012
- Primary completion31 Dec 2012
- Study completion31 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies 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
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yeh, Chung Shan Medical University
- Investigators
- Maw Sheng Lee, Study chair, Lee's Women Hospital, Taichung, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03103113
- Sponsor's protocol ID
- CS12033
- Status last verified
- Mar 2017
- First submitted
- 31 Mar 2017
- Last updated
- 6 Apr 2017
- Results posted
- No
- Individual data sharing
- Yes: IPD can be shared after manuscription publication
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Division of Infertility, Lee Women's Hospital, Taichung, Taiwan
- ClinicalTrials.gov ID
- NCT03103113
- Acronym / sponsor ID
- CS12033
- Conditions
- Infertility, Female, Immune Tolerance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- YehUniversity, hospital or other
- Study start
- 30 Apr 2012 (actual)
- Primary completion
- 31 Dec 2012 (actual)
- Study completion
- 31 Dec 2012 (actual)
- First posted
- 6 Apr 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.
The purpose of this study was to assess the relationship between infertility blood test results and outcomes of pregnancy and alive birth of women who underwent with or without intravenous immunoglobulin (IVIG) before in vitro fertilization.
Detailed description
Study Design (Brief Description)
- Inclusion criteria Patients had underwent infertility blood test or treatment in Lee's women hospital
- Exclusion criteria No
- Endpoint
- Values of blood test (PTT, IDM, ANA, Lupus, protein-s) 2. Embryo quality 3. Results of intravenous immunoglobulin (IVIG) treatment (pregnancy or not) 4. Alive birth rate
- Withdraw criteria and rescue medication No 5. Sample Size and Study Duration Sample Size: total 500 women who underwent IVF treatments and tests from Jan. 2007 to Dec. 2010.
Study Duration: from date of IRB agreement to Dec. 2012 6. Please specify objectives of study when collecting extra specimen from participants No more need to collect extra specimen from participants in this study 7. Expected Endpoints of Treatment No 8. Others No
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients had underwent infertility blood test and in vitro fertilization treatment in Lee's women hospital
Key inclusion criteria (1 listed)
- Patients had underwent both infertility blood test and IVF treatment in Lee's women hospital
Key exclusion criteria (1 listed)
- No
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
implantation rate
Time frame: 6-8 weaks after last menstrual
sac and heart bit can be detected after embryo transfer
1 secondary outcome
live birth rate
Time frame: live birth after pregnant
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 6 Apr 2017.
- Individual participant dataSharing planned: Yes. IPD can be shared after manuscription publication
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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.
Maw Sheng Lee study chair
Lee's Women Hospital, Taichung, Taiwan
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female and Immune Tolerance, run by Yeh.
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 1 inclusion and 1 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 6 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
implantation rate (time frame: 6-8 weaks after last menstrual). 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 6 Apr 2017.