Fertility DisordersNCT05409729
Subclinical Hypothyrodism and Ovarian Reserve
An observational study of Fertility Disorders, run by Assiut University at 1 site in Egypt.
Trial summary
This study aimed to evaluate the potential association of subclinical hypothyrodism and ovarian reserve in reproductive age in age groups more than 35 and age groups less than 35 using retrospective study included women with subclinical hypothyrodism and controls .Evaluation of potential association of antithyroid… Read more about this study
- Who is it for?
- Ages 13 to 45 years, women only
- Conditions the study is for
- Fertility Disorders
- What is being tested?
- retrospective charts reviewing
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2016to 1 Aug 2023
- 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 13 to 45 years
- Women only
- Child, Adult
Study population: patients with thyroid dysfunction who seeking fertility
Who may be able to join
- All reproductive age groups included women less than 35 and women more than 35
Who cannot join
- Previous ovarian surgery Women with long term thyroid hormone replacement Endometriosis History of radiotheraby
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut Medical School
Asyut, 71511
Eman Ahmed Abed Eltawaab, MBBCH, 01065933793, emanedahmed49@gmail.com
About this study
Official title: Evaluation of Ovarian Reserve in Women With Subclinical Hypothyrodism in Reproductive Age
This study aimed to evaluate the potential association of subclinical hypothyrodism and ovarian reserve in reproductive age in age groups more than 35 and age groups less than 35 using retrospective study included women with subclinical hypothyrodism and controls .Evaluation of potential association of antithyroid antibodies positivity on ovarian reserve
Primary outcome:
Measure the association of SCH with ovarian reserve markers (basal FSH ,LH/basal AFC /AMH)
Read the detailed description
Thyroid dysfunction is one of the commonest disorders in women of reproductive age .there is association between subclinical hypothyrodism and infertility and ovarian reserve .It's known that subclinical hypothyrodism can be associated with reduced ovarian reserve in women more than 35 years old .Aclear association between subclinical hypothyrodism and ovarian reserve not established in reproductive age in women less than 35 .This retrospective study investigate serum thyroid hormone /Antithyroid hormone ,ovarian reserve markers (basal FSH,AMH,Antral follicle count on day 2-4/prolactin level .
- Conditions
- Fertility Disorders
- Being tested
- retrospective charts reviewing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrospective charts reviewingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the association of SCH with ovarian reserve markers (basal FSH ,LH/basal AFC /AMH)
This study aimed to evaluate the potential association of subclinical hypothyrodism and ovarian reserve in reproductive age in age groups more than 35 and age groups less than 35 using retrospective study included women with subclinical hypothyrodism and controls .Evaluation of potential association of antithyroid antibodies positivity on ovarian reserve
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start1 Jan 2016
- Primary completion1 Jan 2020
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fertility DisordersStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Ahmed Abed Eltawaab Abdo, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05409729
- Sponsor's protocol ID
- AMH
- Status last verified
- Jun 2022
- First submitted
- 4 Jun 2022
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rao M, Wang H, Zhao S, Liu J, Wen Y, Wu Z, Yang Z, Su C, Su Z, Wang K, Tang L. Subclinical Hypothyroidism Is Associated with Lower Ovarian Reserve in Women Aged 35 Years or Older. Thyroid. 2020 Jan;30(1):95-105. doi: 10.1089/thy.2019.0031. Epub 2019 Dec 20.
PubMed 31650898Korevaar TIM, Minguez-Alarcon L, Messerlian C, de Poortere RA, Williams PL, Broeren MA, Hauser R, Souter IC. Association of Thyroid Function and Autoimmunity with Ovarian Reserve in Women Seeking Infertility Care. Thyroid. 2018 Oct;28(10):1349-1358. doi: 10.1089/thy.2017.0582. Epub 2018 Aug 14.
PubMed 29943679
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ovarian Reserve in Women With Subclinical Hypothyrodism in Reproductive Age
- ClinicalTrials.gov ID
- NCT05409729
- Acronym / sponsor ID
- AMH
- Conditions
- Fertility Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 8 Jun 2022 (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.
This study aimed to evaluate the potential association of subclinical hypothyrodism and ovarian reserve in reproductive age in age groups more than 35 and age groups less than 35 using retrospective study included women with subclinical hypothyrodism and controls .Evaluation of potential association of antithyroid antibodies positivity on ovarian reserve
Primary outcome:
Measure the association of SCH with ovarian reserve markers (basal FSH ,LH/basal AFC /AMH)
Detailed description
Thyroid dysfunction is one of the commonest disorders in women of reproductive age .there is association between subclinical hypothyrodism and infertility and ovarian reserve .It's known that subclinical hypothyrodism can be associated with reduced ovarian reserve in women more than 35 years old .Aclear association between subclinical hypothyrodism and ovarian reserve not established in reproductive age in women less than 35 .This retrospective study investigate serum thyroid hormone /Antithyroid hormone ,ovarian reserve markers (basal FSH,AMH,Antral follicle count on day 2-4/prolactin level .
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 13 to 45 years
- Sex
- Female only
- Age groups
- Child, Adult
- Study population
- patients with thyroid dysfunction who seeking fertility
Key inclusion criteria (1 listed)
- All reproductive age groups included women less than 35 and women more than 35
Key exclusion criteria (1 listed)
- Previous ovarian surgery Women with long term thyroid hormone replacement Endometriosis History of radiotheraby
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 |
|---|---|---|
| retrospective charts reviewing | Behavioural | – |
Primary outcome
Measure the association of SCH with ovarian reserve markers (basal FSH ,LH/basal AFC /AMH)
Time frame: 48 months
This study aimed to evaluate the potential association of subclinical hypothyrodism and ovarian reserve in reproductive age in age groups more than 35 and age groups less than 35 using retrospective study included women with subclinical hypothyrodism and controls .Evaluation of potential association of antithyroid antibodies positivity on ovarian reserve
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- Results publication: PubMed 31650898Rao M, Wang H, Zhao S, Liu J, Wen Y, Wu Z, Yang Z, Su C, Su Z, Wang K, Tang L. Subclinical Hypothyroidism Is Associated with Lower Ovarian Reserve in Women Aged 35 Years or Older. Thyroid. 2020 Jan;30(1):95-105. doi: 10.1089/thy.2019.0031. Epub 2019 Dec 20.
- Results publication: PubMed 29943679Korevaar TIM, Minguez-Alarcon L, Messerlian C, de Poortere RA, Williams PL, Broeren MA, Hauser R, Souter IC. Association of Thyroid Function and Autoimmunity with Ovarian Reserve in Women Seeking Infertility Care. Thyroid. 2018 Oct;28(10):1349-1358. doi: 10.1089/thy.2017.0582. Epub 2018 Aug 14.
- 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.
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 Fertility Disorders, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 Jun 2022. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eman Ahmed Abed Eltawaab, MBBCH (01065933793, emanedahmed49@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the association of SCH with ovarian reserve markers (basal FSH ,LH/basal AFC /AMH) (time frame: 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05409729, which also lists 2 linked publications.
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 8 Jun 2022.