In Vitro FertilizationNCT01600794
To Evaluate The Anrogens and Ovary Function in In Vitro Fertilization
An observational study of In Vitro Fertilization, run by Taipei Medical University WanFang Hospital.
Trial summary
Because the society convention is changed, people are late for getting married, leading to increasing the bearing age in women. According to the previous study, if the age is over 30, the oocyte number in ovary has left only 10％ and 3％ in over 40 years old. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- In Vitro Fertilization
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Oct 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: This study include the patients who are evaluated by the doctors and are sure to process the IVF cycle.
Who may be able to join
- This study include the patients who are evaluated by the doctors and are sure to process the IVF cycle.
Who cannot join
- This study exclude the patients who are not evaluated by the doctors and are not sure to process the IVF cycle.
About this study
Official title: To Evaluate The Androgens and Ovary Function Impact on The Pregnancy Outcome in In Vitro Fertilization
Because the society convention is changed, people are late for getting married, leading to increasing the bearing age in women. According to the previous study, if the age is over 30, the oocyte number in ovary has left only 10％ and 3％ in over 40 years old. The data is collected by Bureau of Health Promotion, Department of Health shows that there are about 7000 people treating the infertility and it spends about 150000 to 250000 NT dollars in every in vitro fertilization (IVF) cycle, but the live birth rate is only 30％. So it is important to know how to estimate and approve the ovary function that lead to increase the live birth rate. The investigators plan to estimate the correlation between the serum androgens levels and pregnancy outcome in the women who have infertility problem. Furthermore, for the repeated IVF cycle, the ovary function might be re-evlauated because of the possible effect from stimulated drugs used on previous cycle. It's important to understand the ovary function for IVF patient to choose the appropriate drugs and dose.
The investigators use blood and clinical test to analyze, the items for analysis are below:
- Routine blood test: FSH、LH、E2、P4、Anti-Mullerian Hormone(AMH)、
- Studied blood test: Inhibin B、total testosterone (TT)、Androstenedione、DHEA-S
- Clinical test: Ultrasound
- Personal condition. In order to finishing the test, every patient will be asked to collect about 10 to 15 cc blood for the research.
- Conditions
- In Vitro Fertilization
- Keywords
- In Vitro Fertilization (IVF), androgens, ovary function, This study include the patients who are evaluated by the doctors and are sure to process the In Vitro Fertilization cycle.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| male/female, immunity or others factor infertility, IVF | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2012 (estimated)
- Study startOct 2011
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In Vitro FertilizationStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming-I Hsu, Taipei Medical University WanFang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01600794
- Sponsor's protocol ID
- WFH-TMU-IVF-201107012
- Status last verified
- May 2012
- First submitted
- 14 May 2012
- Last updated
- 17 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate The Androgens and Ovary Function Impact on The Pregnancy Outcome in In Vitro Fertilization
- ClinicalTrials.gov ID
- NCT01600794
- Acronym / sponsor ID
- WFH-TMU-IVF-201107012
- Conditions
- In Vitro Fertilization
- Keywords
- In Vitro Fertilization (IVF), androgens, ovary function, This study include the patients who are evaluated by the doctors and are sure to process the In Vitro Fertilization cycle.
- Study type
- Observational
- Recruitment status
- Suspended
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- Oct 2011
- Study completion
- Oct 2012 (estimated)
- First posted
- 17 May 2012 (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.
Because the society convention is changed, people are late for getting married, leading to increasing the bearing age in women. According to the previous study, if the age is over 30, the oocyte number in ovary has left only 10％ and 3％ in over 40 years old. The data is collected by Bureau of Health Promotion, Department of Health shows that there are about 7000 people treating the infertility and it spends about 150000 to 250000 NT dollars in every in vitro fertilization (IVF) cycle, but the live birth rate is only 30％. So it is important to know how to estimate and approve the ovary function that lead to increase the live birth rate. The investigators plan to estimate the correlation between the serum androgens levels and pregnancy outcome in the women who have infertility problem. Furthermore, for the repeated IVF cycle, the ovary function might be re-evlauated because of the possible effect from stimulated drugs used on previous cycle. It's important to understand the ovary function for IVF patient to choose the appropriate drugs and dose.
The investigators use blood and clinical test to analyze, the items for analysis are below:
- Routine blood test: FSH、LH、E2、P4、Anti-Mullerian Hormone(AMH)、
- Studied blood test: Inhibin B、total testosterone (TT)、Androstenedione、DHEA-S
- Clinical test: Ultrasound
- Personal condition. In order to finishing the test, every patient will be asked to collect about 10 to 15 cc blood for the research.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| male/female, immunity or others factor infertility, IVF | – | – |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This study include the patients who are evaluated by the doctors and are sure to process the IVF cycle.
Key inclusion criteria (1 listed)
- This study include the patients who are evaluated by the doctors and are sure to process the IVF cycle.
Key exclusion criteria (1 listed)
- This study exclude the patients who are not evaluated by the doctors and are not sure to process the IVF cycle.
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of In Vitro Fertilization, run by Taipei Medical University WanFang Hospital.
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: paused, as of the sponsor's last update on 17 May 2012. 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?
Results are not available in the source record.
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.
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 17 May 2012.