Subclinical Hypothyroidism and Normogonadotropic Anovulation

Polycystic Ovary Syndrome Clinical Trial

Official title:

Subclinical Hypothyroidism and Ovarian Reserve Indices in Women With Normogonadotropic Anovulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05782725
• Other study ID #: 1072.6120.172.2022
• Status: Completed
• Start date: March 1, 2023
• Est. completion date: January 10, 2024

Study information

• Verified date: February 2024
• Source: Jagiellonian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: January 10, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• age 18-45

• irregular periods

• infertility due to ovulation disorders

• euthyreosis

Exclusion Criteria:

• diagnosed and treated thyroid dysfunction,

• history of thyroidectomy

Related Conditions & MeSH terms

• Anovulation
• Hypothyroidism
• Pituitary Diseases
• Polycystic Ovary Syndrome

Intervention

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

Locations

Country	Name	City	State
Poland	Jagiellonian University Medical College, Department of Gynecology and Obstetrics	Krakow

Sponsors (1)

Lead Sponsor	Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood serum AMH concentration	Measurement of serum AMH concentration in women in 4 arms of the study	01.07.2022-01.12.2023
Secondary	Blood serum FSH, LH, estradiol	Measurement of serum FSH, LH, estradiol concentration in women in 4 arms of the study	01.07.2022-01.12.2023
Secondary	AFC/ovarian volume	Ultrasound measurement of AFC/ovarian volume	01.07.2022-01.12.2023