Clinical trial NCT05782725: Subclinical Hypothyroidism and Normogonadotropic Anovulation
Official title: Subclinical Hypothyroidism and Ovarian Reserve Indices in Women With Normogonadotropic Anovulation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome
Hypothalamic-Pituitary-Ovarian Axis Dysfunction (Disorder)
Keywords: Polycystic ovary syndrome
Hypothalamic-Pituitary-Ovarian axis dysfunction
Ovarian reserve
Anovulation
Any-Mullerian hormone
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2023-03-23
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study group will consist of women aged 18-45, diagnosed due to menstrual disorders and/or infertility due to ovulation disorders. Inclusion criteria will include age 18-45 and euthyroidism. The exclusion criteria will be: i) diagnosed and treated thyroid dysfunction, ii) history of thyroidectomy. The study population of women will be characterized in terms of demographic (age, BMI) and obstetric data (pregnancy, childbirth, miscarriage, cycle length, infertility).

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* diagnosed and treated thyroid dysfunction,
* history of thyroidectomy

Primary outcomes:
measure: Blood serum AMH concentration
timeFrame: 01.07.2022-01.12.2023
Secondary outcomes:
measure: Blood serum FSH, LH, estradiol
timeFrame: 01.07.2022-01.12.2023
measure: AFC/ovarian volume
timeFrame: 01.07.2022-01.12.2023
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: Jagiellonian University Medical College, Department of Gynecology and Obstetrics
Study officials:
affiliation: Jagiellonian University
name: Robert Jach, Prof.
role: STUDY_CHAIR
References: