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NCT Number: NCT05782725

Subclinical Hypothyroidism and Normogonadotropic Anovulation

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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Anovulation Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Hypothalamic-Pituitary-Ovarian Axis Dysfunction (Disorder) Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Jagiellonian University Medical College, Department of Gynecology and Obstetrics

Krakow, 31-501, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • diagnosed and treated thyroid dysfunction,
  • history of thyroidectomy

Treatment and study plan

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

Other

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

Primary outcomes

  1. Blood serum AMH concentration

    Time frame: 01.07.2022-01.12.2023

    Measurement of serum AMH concentration in women in 4 arms of the study

Secondary outcomes

  1. Blood serum FSH, LH, estradiol

    Time frame: 01.07.2022-01.12.2023

    Measurement of serum FSH, LH, estradiol concentration in women in 4 arms of the study

  2. AFC/ovarian volume

    Time frame: 01.07.2022-01.12.2023

    Ultrasound measurement of AFC/ovarian volume

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Official study title

Subclinical Hypothyroidism and Ovarian Reserve Indices in Women With Normogonadotropic Anovulation

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Mar 23, 2023
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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