ThyroidNCT02912442
Thyroid Autoimmunity and Reproductive Failure in Danish Women
An observational study of Thyroid and Infertility, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The present Ph.D.-study investigates the mechanisms behind the association between thyroid autoimmunity and reproductive failure. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Thyroid, Infertility, Autoantibodies
- How many people
- 1,200 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2016to Dec 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Women referred to the infertility clinic
Who may be able to join
- Women followed in the Fertility Clinic
Who cannot join
- Pregnancy at time of blood sampling. Immune-suppressive ⁄modulatory treatments. Women referred for oocyt donation, genetic testing, and hepatitis and HIV-positivity
Trial locations and contacts
1 site in 1 country.
Ulla Feldt-Rasmussen, Proff., DMSc contact
About this study
Official title: Thyroid Autoimmunity and Reproductive Failure - a Study of Autoimmunity in Association With Treatment Outcome in Infertile Danish Women With Infertility or Recurrent Miscarriages.
The present Ph.D.-study investigates the mechanisms behind the association between thyroid autoimmunity and reproductive failure.
- Conditions
- Thyroid, Infertility, Autoantibodies, Autoimmunity, Pregnancy Loss
- Keywords
- thyroid, infertility, autoimmunity, pregnancy loss, autoantibodies
- Medical subject headings
- Thyroid Diseases, Infertility, Autoimmune Diseases
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 |
|---|---|---|
| Infertile women study 1 | Not described | |
| Infertile women study 2 | Not described | |
| Repeated pregnancy loss | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth
Measured: 2011-2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThyroidStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulla Feldt-Rasmussen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02912442
- Sponsor's protocol ID
- THY-FER-IMM
- Status last verified
- Sep 2016
- First submitted
- 21 Sep 2016
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyroid Autoimmunity and Reproductive Failure - a Study of Autoimmunity in Association With Treatment Outcome in Infertile Danish Women With Infertility or Recurrent Miscarriages.
- ClinicalTrials.gov ID
- NCT02912442
- Acronym / sponsor ID
- THY-FER-IMM
- Conditions
- Thyroid, Infertility, Autoantibodies, Autoimmunity, Pregnancy Loss
- Keywords
- thyroid, infertility, autoimmunity, pregnancy loss, autoantibodies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 23 Sep 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.
The present Ph.D.-study investigates the mechanisms behind the association between thyroid autoimmunity and reproductive failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Infertile women study 1 | – | – |
| Infertile women study 2 | – | – |
| Repeated pregnancy loss | – | – |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women referred to the infertility clinic
Key inclusion criteria (1 listed)
- Women followed in the Fertility Clinic
Key exclusion criteria (1 listed)
- Pregnancy at time of blood sampling. Immune-suppressive ⁄modulatory treatments. Women referred for oocyt donation, genetic testing, and hepatitis and HIV-positivity
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
Time frame: 2011-2015
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
- Individual participant dataSharing planned: Undecided. Undecided
Related trials for Thyroid
Recruiting
NIRAF-Guided Parathyroid Identification During Thyroidectomy
Hypocalcemia, Hypoparathyroidism
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Not yet recruitingObservational study
Validation of Uzbek SARC-F and IPAQ-SF Questionnaires in Adults With and Without Hypothyroidism
Hypothyroidism, Psychometrics
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
Recruiting
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Thyroid Diseases, Wound Healing
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.
Ulla Feldt-Rasmussen, Proff., DMSc contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid and Infertility, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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: status not confirmed, as of the sponsor's last update on 23 Sep 2016. 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 Denmark. 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 Ulla Feldt-Rasmussen, Proff., DMSc (ulla.feldt-rasmussen@dadlnet.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth (time frame: 2011-2015). 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 23 Sep 2016.