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Subclinical Hypothyroidism and Normogonadotropic Anovulation

Subclinical Hypothyroidism and Ovarian Reserve Indices in Women With Normogonadotropic Anovulation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05782725
Enrollment
300
Registered
2023-03-23
Start date
2023-03-01
Completion date
2024-01-10
Last updated
2024-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypothalamic-Pituitary-Ovarian Axis Dysfunction (Disorder), Polycystic Ovary Syndrome

Keywords

Polycystic ovary syndrome, Hypothalamic-Pituitary-Ovarian axis dysfunction, Ovarian reserve, Anovulation, Any-Mullerian hormone

Brief summary

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.

Detailed description

Purpose of the study Evaluation of ovarian reserve indices in women with normogonadotropic anovulation with SCH and without thyroid disease. Detailed objectives i) Assessment of AMH, FSH, LH, estradiol, astral follicle count (AFC)/ovarian volume in the subpopulation of women with PCOS and SCH compared to women with PCOS without thyroid disease ii) Assessment of AMH, FSH, LH, estradiol, AFC/ovarian volume in the subpopulation of women with HPOD (other than PCOS) with SCH compared to women with HPOD without thyroid disease iii) Comparison of AMH, FSH, LH, estradiol, AFC/ovarian volume in women with PCOS and HPOD with and without thyroid disease and evaluation of correlation with US ovarian morphology iv) Calculation of the cut-off point of AMH concentration correlating with a high probability of PCOS diagnosis and TSH correlating with unfavorable parameters of ovarian function/HPO axis.

Interventions

OTHERComparison of laboratory test results in women in the 4 study arms

Comparison of AMH, FSH, LH, estradiol, AFC/ ovarian volume on ultrasound in women in the 4 study arms

Sponsors

Jagiellonian University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* age 18-45 * irregular periods * infertility due to ovulation disorders * euthyreosis

Exclusion criteria

* diagnosed and treated thyroid dysfunction, * history of thyroidectomy

Design outcomes

Primary

MeasureTime frameDescription
Blood serum AMH concentration01.07.2022-01.12.2023Measurement of serum AMH concentration in women in 4 arms of the study

Secondary

MeasureTime frameDescription
Blood serum FSH, LH, estradiol01.07.2022-01.12.2023Measurement of serum FSH, LH, estradiol concentration in women in 4 arms of the study
AFC/ovarian volume01.07.2022-01.12.2023Ultrasound measurement of AFC/ovarian volume

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026