Infertility and MiscarriageFertilityNCT02925390
Natural Procreative Technology Evaluation and Surveillance of Treatment for Infertility and Miscarriage
An observational study of Infertility and Miscarriage, run by St. Louis University.
Trial summary
This study involves research, and the purpose of this study is to evaluate live birth rates among couples who are treated by Natural procreative technology, (NPT) for infertility and miscarriage. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Infertility and Miscarriage
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to 10 Sep 2020
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Couples seeking NPT treatment or consultation to achieve pregnancy, to maintain pregnancy, or for fertility-related health issues will recruited from our practice. Providers will present the study information to the patients at their initial visit. No recruitment by phone or mail will be done.
Who may be able to join
- Couple or women, seeking NPT treatment or consultation to achieve pregnancy, to maintain pregnancy, or for fertility-related health issues.
- Couple or women who is seeking pregnancy WITHIN the coming year.
Who cannot join
- Couple or women is not a candidate for NPT for pregnancy (for example, couple or women is medically sterile or medically too high risk for pregnancy).
- Couple or women is not able to provide informed consent (for example, language barriers).
About this study
This study involves research, and the purpose of this study is to evaluate live birth rates among couples who are treated by Natural procreative technology, (NPT) for infertility and miscarriage.
Comparisons will be made to those declining NPT treatment, waiting for NPT treatment, receiving other treatment, or stopping treatment. The investigator seeks to document specific pregnancy rates for different factors such as age and type of infertility diagnosis. Investigators will also assess characteristics of environmental exposures that may be associated with infertility. Couples will be followed for up to three years, regardless of when they begin NPT treatment, or whether they continue treatment. Data from all couples will be useful for this study, regardless of their individual circumstances or actual treatment.
Read the detailed description
This is a prospective cohort observational study. Couples presenting for possible treatment with NPT will be recruited for participation in the study. No randomization will occur. If a couple agrees to participate, investigators will collect information in three ways:
- Questionnaires. (standard of care) These will be done at entry (SOC) to the study, on an annual basis for up to three years (research related), for any pregnancy, or whenever a patient exits the study. Questionnaires may be done by mail, email, or telephone. Each questionnaire has a woman's and a man's version, except the pregnancy questionnaire, which only has a woman's version. Each questionnaire will take approximately 30-45 minutes to complete.
- The subject's own Creighton Model fertility charts. (standard of care)
- Information about NPT treatment and pregnancies from the medical records of their NPT physician(s). (standard of care)
- Conditions
- Infertility and Miscarriage
- Medical subject headings
- Infertility, Abortion, Spontaneous
What is being measured
The primary outcome is the main question the study is designed to answer.
live birth rates over time for patients who are treated with natural procreative technology
to determine what the live birth rates are over time for patients who are treated with natural procreative technology (NPT) for infertility or history of spontaneous abortion, and how the live birth rate may vary by patient characteristics, especially the age of the woman, prior pregnancy, and underlying diagnoses
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 posted5 Oct 2016 (estimated)
- Study startSep 2016
- Primary completion10 Sep 2020
- Study completion10 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility and MiscarriageStudies 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
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Yeung Jr., MD, St. Louis University
- Investigators
- Patrick Yeung, MD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02925390
- Sponsor's protocol ID
- 26221
- Acronym
- Fertility
- Status last verified
- Sep 2020
- First submitted
- 4 Oct 2016
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural Procreative Technology Evaluation and Surveillance of Treatment for Infertility and Miscarriage
- ClinicalTrials.gov ID
- NCT02925390
- Acronym / sponsor ID
- Fertility / 26221
- Conditions
- Infertility and Miscarriage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- 10 Sep 2020 (actual)
- Study completion
- 10 Sep 2020 (actual)
- First posted
- 5 Oct 2016 (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.
This study involves research, and the purpose of this study is to evaluate live birth rates among couples who are treated by Natural procreative technology, (NPT) for infertility and miscarriage.
Comparisons will be made to those declining NPT treatment, waiting for NPT treatment, receiving other treatment, or stopping treatment. The investigator seeks to document specific pregnancy rates for different factors such as age and type of infertility diagnosis. Investigators will also assess characteristics of environmental exposures that may be associated with infertility. Couples will be followed for up to three years, regardless of when they begin NPT treatment, or whether they continue treatment. Data from all couples will be useful for this study, regardless of their individual circumstances or actual treatment.
Detailed description
This is a prospective cohort observational study. Couples presenting for possible treatment with NPT will be recruited for participation in the study. No randomization will occur. If a couple agrees to participate, investigators will collect information in three ways:
- Questionnaires. (standard of care) These will be done at entry (SOC) to the study, on an annual basis for up to three years (research related), for any pregnancy, or whenever a patient exits the study. Questionnaires may be done by mail, email, or telephone. Each questionnaire has a woman's and a man's version, except the pregnancy questionnaire, which only has a woman's version. Each questionnaire will take approximately 30-45 minutes to complete.
- The subject's own Creighton Model fertility charts. (standard of care)
- Information about NPT treatment and pregnancies from the medical records of their NPT physician(s). (standard of care)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Couples seeking NPT treatment or consultation to achieve pregnancy, to maintain pregnancy, or for fertility-related health issues will recruited from our practice. Providers will present the study information to the patients at their initial visit. No recruitment by phone or mail will be done.
Key inclusion criteria (2 listed)
- Couple or women, seeking NPT treatment or consultation to achieve pregnancy, to maintain pregnancy, or for fertility-related health issues.
- Couple or women who is seeking pregnancy WITHIN the coming year.
Key exclusion criteria (2 listed)
- Couple or women is not a candidate for NPT for pregnancy (for example, couple or women is medically sterile or medically too high risk for pregnancy).
- Couple or women is not able to provide informed consent (for example, language barriers).
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
live birth rates over time for patients who are treated with natural procreative technology
Time frame: 3 years
to determine what the live birth rates are over time for patients who are treated with natural procreative technology (NPT) for infertility or history of spontaneous abortion, and how the live birth rate may vary by patient characteristics, especially the age of the woman, prior pregnancy, and underlying diagnoses
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 10 Sep 2020.
- 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.
Patrick Yeung, MD principal investigator
St. Louis University
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility and Miscarriage, run by St. Louis University.
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 2 inclusion and 2 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 10 Sep 2020. 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?
live birth rates over time for patients who are treated with natural procreative technology (time frame: 3 years). 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 10 Sep 2020.