Polycystic Ovary SyndromeNCT05782725
Subclinical Hypothyroidism and Normogonadotropic Anovulation
An observational study of Polycystic Ovary Syndrome and Hypothalamic-Pituitary-Ovarian Axis Dysfunction (Disorder), run by Jagiellonian University at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Hypothalamic-Pituitary-Ovarian Axis Dysfunction (Disorder)
- What is being tested?
- Comparison of laboratory test results in women in the 4 study arms
- How many people
- 300 participants
- Where
- 1 sitePoland
- Study dates
- 1 Mar 2023to 10 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
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).
Who may be able to join
- age 18-45
- irregular periods
- infertility due to ovulation disorders
- euthyreosis
Who cannot join
- diagnosed and treated thyroid dysfunction,
- history of thyroidectomy
Trial locations and contacts
1 site in 1 country.
Poland1 site
Jagiellonian University Medical College, Department of Gynecology and Obstetrics
Krakow, 31-501
About this study
Official title: Subclinical Hypothyroidism and Ovarian Reserve Indices in Women With Normogonadotropic Anovulation
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.
Read the detailed description
Purpose of the study
Evaluation of ovarian reserve indices in women with normogonadotropic anovulation with SCH and without thyroid disease.
Detailed objectives
- 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.
- Being tested
- Comparison of laboratory test results in women in the 4 study arms
- Keywords
- Polycystic ovary syndrome, Hypothalamic-Pituitary-Ovarian axis dysfunction, Ovarian reserve, Anovulation, Any-Mullerian hormone
- Medical subject headings
- Polycystic Ovary Syndrome, Anovulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | PCOS and SCH Receives: Other: Comparison of laboratory test results in women in the 4 study arms | |
| 2 | PCOH without SCH Receives: Other: Comparison of laboratory test results in women in the 4 study arms | |
| 3 | HPOD and SCH Receives: Other: Comparison of laboratory test results in women in the 4 study arms | |
| 4 | HPOD without SCH Receives: Other: Comparison of laboratory test results in women in the 4 study arms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood serum AMH concentration
Measurement of serum AMH concentration in women in 4 arms of the study
Measured: 01.07.2022-01.12.2023
Secondary outcomes (2)
Blood serum FSH, LH, estradiol
Measurement of serum FSH, LH, estradiol concentration in women in 4 arms of the study
Measured: 01.07.2022-01.12.2023
AFC/ovarian volume
Ultrasound measurement of AFC/ovarian volume
Measured: 01.07.2022-01.12.2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start1 Mar 2023
- Primary completion1 Dec 2023
- Study completion10 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iwona Magdalena Gawron, Jagiellonian University
- Investigators
- Robert Jach, Prof., Study chair, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782725
- Sponsor's protocol ID
- 1072.6120.172.2022
- Status last verified
- Feb 2024
- First submitted
- 11 Mar 2023
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subclinical Hypothyroidism and Ovarian Reserve Indices in Women With Normogonadotropic Anovulation
- ClinicalTrials.gov ID
- NCT05782725
- Acronym / sponsor ID
- 1072.6120.172.2022
- Keywords
- Polycystic ovary syndrome, Hypothalamic-Pituitary-Ovarian axis dysfunction, Ovarian reserve, Anovulation, Any-Mullerian hormone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Comparison of laboratory test results in women in the 4 study armsPCOS and SCH |
| 2 | – | Other: Comparison of laboratory test results in women in the 4 study armsPCOH without SCH |
| 3 | – | Other: Comparison of laboratory test results in women in the 4 study armsHPOD and SCH |
| 4 | – | Other: Comparison of laboratory test results in women in the 4 study armsHPOD without SCH |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (4 listed)
- age 18-45
- irregular periods
- infertility due to ovulation disorders
- euthyreosis
Key exclusion criteria (2 listed)
- diagnosed and treated thyroid dysfunction,
- history of thyroidectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comparison of laboratory test results in women in the 4 study armsComparison of AMH, FSH, LH, estradiol, AFC/ ovarian volume on ultrasound in women in the 4 study arms | Other | 1, 2, 3, 4 |
Primary outcome
Blood serum AMH concentration
Time frame: 01.07.2022-01.12.2023
Measurement of serum AMH concentration in women in 4 arms of the study
2 secondary outcomes
Blood serum FSH, LH, estradiol
Time frame: 01.07.2022-01.12.2023
AFC/ovarian volume
Time frame: 01.07.2022-01.12.2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Jach, Prof. study chair
Jagiellonian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome and Hypothalamic-Pituitary-Ovarian Axis Dysfunction (Disorder), run by Jagiellonian University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood serum AMH concentration (time frame: 01.07.2022-01.12.2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.