Hyperprolactinaemia Management in Reproductive Services at University Hospital of Coventry and Warwickshire

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Brief Title

Hyperprolactinaemia Management in Reproductive Services at University Hospital of Coventry and Warwickshire

Official Title

A Retrospective Cohort Study of Hyperprolactinaemia Management in Reproductive Services at University Hospital of Coventry and Warwickshire (UHCW)

Brief 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. 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 Type

Observational


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

Secondary Outcome

 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

Condition

Hyperprolactinemia

Intervention

MRI Pituitary

Study Arms / Comparison Groups

 Patients with hyperprolactinaemia
Description:  Patients undergoing subfertility studies with at least one high prolactin reading (>500mU/L).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

107

Start Date

September 25, 2017

Completion Date

December 1, 2017

Primary Completion Date

December 1, 2017

Eligibility Criteria

        Inclusion Criteria:

          -  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)

        Exclusion Criteria:

          -  Referred outside of study period

          -  Hyperprolactinaemia reading outside of study period
      

Gender

Female

Ages

N/A - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, , 

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT03569787

Organization ID

GF0253


Responsible Party

Sponsor

Study Sponsor

University Hospitals Coventry and Warwickshire NHS Trust


Study Sponsor

, , 


Verification Date

June 2018