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

NCT03569787 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 107

Last updated 2018-06-26

No results posted yet for this study

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.

Conditions

  • Hyperprolactinemia
  • Subfertility
  • Subclinical hypothyroïdism

Interventions

DIAGNOSTIC_TEST

MRI Pituitary

Identification of whether of not patients had had an MRI pituitary following hyperprolactinaemia reading

Sponsors & Collaborators

  • University Hospitals Coventry and Warwickshire NHS Trust

    lead OTHER

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-25
Primary Completion
2017-12-01
Completion
2017-12-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03569787 on ClinicalTrials.gov