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NCT05782725
Subclinical Hypothyroidism and Normogonadotropic Anovulation
trial testing Comparison of laboratory test results in women in the 4 study arms in Polycystic Ovary Syndrome in 300 participants. Completed in 10 January 2024.
1 December 2023
Quick facts
| Lead sponsor | Jagiellonian University |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 300 |
| Start date | 1 March 2023 |
| Primary completion | 1 December 2023 |
| Estimated completion | 10 January 2024 |
| Sites | 1 location across Poland |
Drugs / interventions tested
- Comparison of laboratory test results in women in the 4 study arms
Conditions studied
- Polycystic Ovary Syndrome — all drugs for Polycystic Ovary Syndrome →
- Hypothalamic-Pituitary-Ovarian Axis Dysfunction (Disorder) — all drugs for Hypothalamic-Pituitary-Ovarian Axis Dysfunction (Disorder) →
Sponsor
Jagiellonian University
Who can join
Adults 18 to 45, female only, with Polycystic Ovary Syndrome or Hypothalamic-Pituitary-Ovarian Axis Dysfunction (Disorder). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Thyroid hormones (TH) can modify the functioning of the hypothalamic-pituitary-ovarian axis, affecting the functions of granulosa cells and the development and apoptosis of preantral follicles. TH receptors are present within the oocytes, and TH and anti-thyroid antibodies (ATA) are present in the follicular fluid. Improper thyroid function can cause ovulation disorders, luteal phase failure, impaired endometrial receptivity and result in implantation failures and recurrent miscarriages. While overt hypothyroidism is treated to improve fertility, the effect of subclinical hypothyroidism (SCH) and the presence of circulating ATAs on fertility and obstetric outcomes is uncertain and data on ovarian reserve rates are conflicting. Among the causes of ovulation disorders (group II according to the WHO classification), polycystic ovary syndrome (PCOS) dominates, found in 3-15% of women of reproductive age, and the remaining group of causes is the so-called Hypothalamic-Pituitary-Ovarian Axis Dysfunction (HPOD). The exact etiology of both entities is unknown.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05782725
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Jagiellonian University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05782725 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jagiellonian University
- Last refreshed: 7 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05782725.
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