NCT05782725

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 23, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2024

Completed
Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

9 months

First QC Date

March 11, 2023

Last Update Submit

February 4, 2024

Conditions

Polycystic Ovary SyndromeHypothalamic-Pituitary-Ovarian Axis Dysfunction (Disorder)

Keywords

Polycystic ovary syndromeHypothalamic-Pituitary-Ovarian axis dysfunctionOvarian reserveAnovulationAny-Mullerian hormone

Outcome Measures

Primary Outcomes (1)

  • Blood serum AMH concentration

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

    01.07.2022-01.12.2023

Secondary Outcomes (2)

  • Blood serum FSH, LH, estradiol

    01.07.2022-01.12.2023

  • AFC/ovarian volume

    01.07.2022-01.12.2023

Study Arms (4)

1

PCOS and SCH

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

2

PCOH without SCH

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

3

HPOD and SCH

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

4

HPOD without SCH

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

Interventions

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

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

1234

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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).

You may qualify if:

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

You may not qualify if:

  • diagnosed and treated thyroid dysfunction,
  • history of thyroidectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jagiellonian University Medical College, Department of Gynecology and Obstetrics

Krakow, 31-501, Poland

Location

MeSH Terms

Conditions

Polycystic Ovary SyndromeAnovulation

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Robert Jach, Prof.

    Jagiellonian University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 11, 2023

First Posted

March 23, 2023

Study Start

March 1, 2023

Primary Completion

December 1, 2023

Study Completion

January 10, 2024

Last Updated

February 7, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)