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Subclinical Hypothyroidism and Normogonadotropic Anovulation

Sponsor
Jagiellonian University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05782725
Collaborator
(none)
300
Enrollment
1
Location
18
Anticipated Duration (Months)
16.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Comparison of laboratory test results in women in the 4 study arms

Detailed Description

Purpose of the study

Evaluation of ovarian reserve indices in women with normogonadotropic anovulation with SCH and without thyroid disease.

Detailed objectives

  1. 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
  2. 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Subclinical Hypothyroidism and Ovarian Reserve Indices in Women With Normogonadotropic Anovulation
Actual Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
1

PCOS and 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
2

PCOH 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
3

HPOD and 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
4

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

Outcome Measures

Primary Outcome Measures

  1. Blood serum AMH concentration [01.07.2022-01.12.2023]

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

Secondary Outcome Measures

  1. Blood serum FSH, LH, estradiol [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 [01.07.2022-01.12.2023]

    Ultrasound measurement of AFC/ovarian volume

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jagiellonian University Medical College, Department of Gynecology and Obstetrics Krakow Poland 31-501

Sponsors and Collaborators

  • Jagiellonian University

Investigators

  • Study Chair: Robert Jach, Prof., Jagiellonian University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Iwona Magdalena Gawron, Ph.D., Jagiellonian University
ClinicalTrials.gov Identifier:
NCT05782725
Other Study ID Numbers:
  • 1072.6120.172.2022
First Posted:
Mar 23, 2023
Last Update Posted:
Mar 23, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Anovulation
Hypothyroidism

Study Results

No Results Posted as of Mar 23, 2023