HyperprolactinemiaNCT03569787
Hyperprolactinaemia Management in Reproductive Services at University Hospital of Coventry and Warwickshire
An observational study of Hyperprolactinemia and Subfertility, run by University Hospitals Coventry and Warwickshire NHS Trust at 1 site in United Kingdom.
Trial summary
Hyperprolactinaemia and thyroid disorders can significantly reduce fertility by causing ovulatory dysfunction. There is no evidence to suggest treatment of hyperprolactinaemia in the presence of regular ovulatory menstruation will improve fertility. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hyperprolactinemia, Subfertility, Subclinical hypothyroïdism
- What is being tested?
- MRI Pituitary
- How many people
- 107 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Sep 2017to 1 Dec 2017
- 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: All patients seen in subfertility services at UHCW between January 2014 to October 2017
Who may be able to join
- Undergoing care through subfertility services at UHCW
- Referred and seen in subfertility services between January 2014 to October 2017
- Identified as having had at least one episode of hyperprolactinaemia within the study period (Jan 2014 to January 2017)
Who cannot join
- Referred outside of study period
- Hyperprolactinaemia reading outside of study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Cohort Study of Hyperprolactinaemia Management in Reproductive Services at University Hospital of Coventry and Warwickshire (UHCW)
Hyperprolactinaemia and thyroid disorders can significantly reduce fertility by causing ovulatory dysfunction. There is no evidence to suggest treatment of hyperprolactinaemia in the presence of regular ovulatory menstruation will improve fertility. However, anecdotal observation of practice at UHCW NHS Trust suggested that dopamine agonists are often prescribed irrespective of whether symptoms of hyperprolactinaemia are present.
The aim of the study was to establish the prevalence of hyperprolactinaemia and incidence of subclinical hypothyroidism in patients undergoing subfertility investigations at UHCW NHS Trust. Also, to examine management of patients with hyperprolactinaemia and a normal pituitary MRI scan, and explore the trends in treatment; and finally, to explore how this could improve reproductive services.
Read more
107 patients were identified as having a high prolactin reading between January 2014 and January 2017. Hospital records were examined for patient demographics, relevant blood and scan results, medical history, any treatment, and treatment outcomes.
The prevalence of hyperprolactinaemia was 23%. 20.6% of patients had suboptimal thyroid function and were started on levothyroxine. Prolactin levels, and presence of relevant symptoms, only had a partial bearing on whether dopamine agonists were used in those with normal pituitary MRI results (or where no scan was performed). The use of dopamine agonists appeared to correlate with assisted conception and a lower incidence of birth complications (inc. miscarriage, prematurity), though the significance of this was limited by the size of the dataset.
Dopamine agonists often appeared to be used in more complex patients, rather than exclusively those with a higher prolactin reading and/or the presence of related symptomatology. Patients frequently underwent a pituitary MRI scan in the absence of symptoms, contrary to evidence. The findings suggest that less patients should be scanned and less treated with dopamine agonists. A health economics evaluation study would be useful to elucidate the potential cost saving this could represent. It may be better to prioritise optimisation of thyroid function, particularly when noting the similarities in the prevalence of suboptimal thyroid function and that of hyperprolactinaemia.
- Conditions
- Hyperprolactinemia, Subfertility, Subclinical hypothyroïdism
- Being tested
- MRI Pituitary
- Medical subject headings
- Hyperprolactinemia, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI PituitaryDiagnostic test
Identification of whether of not patients had had an MRI pituitary following hyperprolactinaemia reading
| Study group | Role | What they receive |
|---|---|---|
| Patients with hyperprolactinaemia | Patients undergoing subfertility studies with at least one high prolactin reading (>500mU/L). Receives: Diagnostic Test: MRI Pituitary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of people referred to subfertility services identified as having at least one high serum prolactin result (>500mU/L) as identified by UHCW CRRS (University Hospital of Coventry and Warwickshire Clinical Records Reporting System) records
Not to date of study start to allow period to follow up on conception and birth data
Measured: January 2014 - January 2017
Number of patients who received a course of dopamine agonist (of any length, at any point during access to subfertility services) as identified by UHCW CRRS (University Hospital of Coventry and Warwickshire Clinical Records Reporting System) records
This typically included bromocriptine or cabergoline. Whether or not they were concurrently treated with Levothyroxine was also recorded (either for new subclinical hypothyroidism or coexisting previously diagnosed hypothyroidism).
Measured: January 2014 - January 2017
Number of patients who received a pituitary MRI scan, and the reported result, as identified by UHCW CRRS records
Measured: January 2014 - October 2017
Secondary outcomes (7)
Demographics of the mother, including: age at referral, BMI at referral, ethnicity, whether primary or secondary subfertility, previous parities, smoking status, any recorded alcohol consumption as identified by UHCW CRRS records
Measured: January 2014 - October 2017
Demographics of father, including: smoking status, any alcohol consumption, semen analysis result, whether the father is receiving treatment for improving semen quality as identified by UHCW CRRS records
Measured: January 2014 - October 2017
Relevant blood results for mother (outlined in desciption), as close as possible to referral date to subfertility services as identified by UHCW CRRS records
Including: anti-mullerian hormone (mU/L); oestrodiol; FSH (IU/L); LH (IU/L); testosterone (nmol/L); SHBG; androstenedione; TSH (mU/L); free T4 (pmol/L); TPO antibodies; TSH receptor antibodies; macroprolactin (where negative is more than 50% recovery following PEG test)
Measured: January 2014 - October 2017
Number of patients who experienced symptoms of hyperprolactinaemia, namely any record of: amenorrhoea, oligomenorrhoea, galactorrhoea (inc. whether unilateral or bilateral) and any other relevant symptoms recorded as identified by UHCW CRRS records
Measured: January 2014 - October 2017
Number of patients identified as having PCOS, including what elements of the Rotterdam Criteria led to diagnosis as identified by UHCW CRRS records
Measured: January 2014 - October 2017
Number of patients with pre-exisitng thyroid disorder, any past medical history, and/or any concomitant medications as identified by UHCW CRRS records
Measured: January 2014 - October 2017
Number of patients that managed to conceive, if this was spontaneous (and if not, by what method of assistance), and the outcome of the pregnancy as identified by UHCW CRRS records
Outcome of pregnancy categorised by: birth at term, premature birth, miscarriage, stillbirth or ectopic
Measured: January 2014 - October 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start25 Sep 2017
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperprolactinemiaStudies 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
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03569787
- Sponsor's protocol ID
- GF0253
- Status last verified
- Jun 2018
- First submitted
- 30 Apr 2018
- Last updated
- 26 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Cohort Study of Hyperprolactinaemia Management in Reproductive Services at University Hospital of Coventry and Warwickshire (UHCW)
- ClinicalTrials.gov ID
- NCT03569787
- Acronym / sponsor ID
- GF0253
- Conditions
- Hyperprolactinemia, Subfertility, Subclinical hypothyroïdism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS TrustUniversity, hospital or other
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 26 Jun 2018 (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.
Hyperprolactinaemia and thyroid disorders can significantly reduce fertility by causing ovulatory dysfunction. There is no evidence to suggest treatment of hyperprolactinaemia in the presence of regular ovulatory menstruation will improve fertility. However, anecdotal observation of practice at UHCW NHS Trust suggested that dopamine agonists are often prescribed irrespective of whether symptoms of hyperprolactinaemia are present.
The aim of the study was to establish the prevalence of hyperprolactinaemia and incidence of subclinical hypothyroidism in patients undergoing subfertility investigations at UHCW NHS Trust. Also, to examine management of patients with hyperprolactinaemia and a normal pituitary MRI scan, and explore the trends in treatment; and finally, to explore how this could improve reproductive services.
107 patients were identified as having a high prolactin reading between January 2014 and January 2017. Hospital records were examined for patient demographics, relevant blood and scan results, medical history, any treatment, and treatment outcomes.
The prevalence of hyperprolactinaemia was 23%. 20.6% of patients had suboptimal thyroid function and were started on levothyroxine. Prolactin levels, and presence of relevant symptoms, only had a partial bearing on whether dopamine agonists were used in those with normal pituitary MRI results (or where no scan was performed). The use of dopamine agonists appeared to correlate with assisted conception and a lower incidence of birth complications (inc. miscarriage, prematurity), though the significance of this was limited by the size of the dataset.
Dopamine agonists often appeared to be used in more complex patients, rather than exclusively those with a higher prolactin reading and/or the presence of related symptomatology. Patients frequently underwent a pituitary MRI scan in the absence of symptoms, contrary to evidence. The findings suggest that less patients should be scanned and less treated with dopamine agonists. A health economics evaluation study would be useful to elucidate the potential cost saving this could represent. It may be better to prioritise optimisation of thyroid function, particularly when noting the similarities in the prevalence of suboptimal thyroid function and that of hyperprolactinaemia.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with hyperprolactinaemia | – | Diagnostic Test: MRI PituitaryPatients undergoing subfertility studies with at least one high prolactin reading (>500mU/L). |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients seen in subfertility services at UHCW between January 2014 to October 2017
Key inclusion criteria (3 listed)
- Undergoing care through subfertility services at UHCW
- Referred and seen in subfertility services between January 2014 to October 2017
- Identified as having had at least one episode of hyperprolactinaemia within the study period (Jan 2014 to January 2017)
Key exclusion criteria (2 listed)
- Referred outside of study period
- Hyperprolactinaemia reading outside of study period
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 |
|---|---|---|
| MRI PituitaryIdentification of whether of not patients had had an MRI pituitary following hyperprolactinaemia reading | Diagnostic test | Patients with hyperprolactinaemia |
Primary outcome
Number of people referred to subfertility services identified as having at least one high serum prolactin result (>500mU/L) as identified by UHCW CRRS (University Hospital of Coventry and Warwickshire Clinical Records Reporting System) records
Time frame: January 2014 - January 2017
Not to date of study start to allow period to follow up on conception and birth data
Number of patients who received a course of dopamine agonist (of any length, at any point during access to subfertility services) as identified by UHCW CRRS (University Hospital of Coventry and Warwickshire Clinical Records Reporting System) records
Time frame: January 2014 - January 2017
This typically included bromocriptine or cabergoline. Whether or not they were concurrently treated with Levothyroxine was also recorded (either for new subclinical hypothyroidism or coexisting previously diagnosed hypothyroidism).
Number of patients who received a pituitary MRI scan, and the reported result, as identified by UHCW CRRS records
Time frame: January 2014 - October 2017
7 secondary outcomes
Demographics of the mother, including: age at referral, BMI at referral, ethnicity, whether primary or secondary subfertility, previous parities, smoking status, any recorded alcohol consumption as identified by UHCW CRRS records
Time frame: January 2014 - October 2017
Demographics of father, including: smoking status, any alcohol consumption, semen analysis result, whether the father is receiving treatment for improving semen quality as identified by UHCW CRRS records
Time frame: January 2014 - October 2017
Relevant blood results for mother (outlined in desciption), as close as possible to referral date to subfertility services as identified by UHCW CRRS records
Time frame: January 2014 - October 2017
Number of patients who experienced symptoms of hyperprolactinaemia, namely any record of: amenorrhoea, oligomenorrhoea, galactorrhoea (inc. whether unilateral or bilateral) and any other relevant symptoms recorded as identified by UHCW CRRS records
Time frame: January 2014 - October 2017
Number of patients identified as having PCOS, including what elements of the Rotterdam Criteria led to diagnosis as identified by UHCW CRRS records
Time frame: January 2014 - October 2017
Number of patients with pre-exisitng thyroid disorder, any past medical history, and/or any concomitant medications as identified by UHCW CRRS records
Time frame: January 2014 - October 2017
Number of patients that managed to conceive, if this was spontaneous (and if not, by what method of assistance), and the outcome of the pregnancy as identified by UHCW CRRS records
Time frame: January 2014 - October 2017
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 26 Jun 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hyperprolactinemia and Subfertility, run by University Hospitals Coventry and Warwickshire NHS Trust at 1 site in United Kingdom.
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 3 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 26 Jun 2018. 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 United Kingdom. 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?
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?
Number of people referred to subfertility services identified as having at least one high serum prolactin result (>500mU/L) as identified by UHCW CRRS (University Hospital of Coventry and Warwickshire Clinical Records Reporting System) records (time frame: January 2014 - January 2017). The study lists 3 primary outcomes in all. 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 26 Jun 2018.