An observational study in Polycystic Ovary Syndrome and Hypothalamic-Pituitary-Ovarian Axis Dysfunction (Disorder), sponsored by Jagiellonian University. Completed at 1 site in Poland. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-02-07.
Sponsored by Jagiellonian University · Observational
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.
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.
956 studies on the registry are indexed under Polycystic Ovary Syndrome; 176 are open to participants now.
This study's enrollment of 300 is above the median of 118 across 223 observational studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →Jagiellonian University is the lead sponsor of 161 studies on the registry; 35 are open to participants now.
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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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
PCOS and SCH
Other: Comparison of laboratory test results in women in the 4 study arms
PCOH without SCH
Other: Comparison of laboratory test results in women in the 4 study arms
HPOD and SCH
Other: Comparison of laboratory test results in women in the 4 study arms
HPOD without SCH
Other: Comparison 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
Blood serum AMH concentration
Measurement of serum AMH concentration in women in 4 arms of the study
Time frame: 01.07.2022-01.12.2023
Blood serum FSH, LH, estradiol
Measurement of serum FSH, LH, estradiol concentration in women in 4 arms of the study
Time frame: 01.07.2022-01.12.2023
AFC/ovarian volume
Ultrasound measurement of AFC/ovarian volume
Time frame: 01.07.2022-01.12.2023
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2023 to primary completion in Dec 2023, 9 months.
Of 71 non-industry observational studies under Polycystic Ovary Syndrome, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 47. This study's 9 months is below that.
Counting every sponsor, half of 74 studies reached it within 14 months; a quarter within 6 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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