Infertility, FemaleNCT03964779
Prevalence of Thyroid Dysfunction and Anti-thyroid Antibodies in Infertile Women
An observational study of Infertility, Female, run by Cairo University at 1 site in Egypt.
Trial summary
The study population will be divided into three groups: Group (A) consisting of 40 infertile women with either unexplained or anovulatory infertility with/without associated male factor of infertility, Group (B) consisting of 40 infertile women with tubal (mechanical) factor of infertility with/without associated male… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Hormonal assay and Antibody assay
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- May 2019to Jan 2020
- 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 20 to 40 years
- Women only
- Adult
Study population: 120 women with infertility will be divided into three groups: * Group (A) consisting of 40 infertile women with either unexplained or anovulatory infertility with/without associated male factor of infertility, * Group (B) consisting of 40 infertile women with tubal (mechanical) factor of infertility with/without associated male factor of infertility, and * Group (C) consisting of 40 women with exclusive male factor of infertility and will be used as a control group.
Who may be able to join
- - Age: 18 - 38 years
- Infertile women whether due to functional, anatomical, male factors OR unexplained OR combined factors
Who cannot join
- - Age: below 18 and above 38 years
- Patients with autoimmune diseases (such as lupus and rheumatoid arthritis)
- Acute illness that require hospitalization
- Patients on the following medications: steroids, dopamine, iodine, amiodarone, lithium, donperidone, thyroid hormone, and phenytoin.
- Patients who work at night.
Trial locations and contacts
1 site in 1 country.
About this study
The study population will be divided into three groups:
- Group (A) consisting of 40 infertile women with either unexplained or anovulatory infertility with/without associated male factor of infertility,
- Group (B) consisting of 40 infertile women with tubal (mechanical) factor of infertility with/without associated male factor of infertility, and
- Group (C) consisting of 40 women with exclusive male factor of infertility and will be used as a control group. . All women will be subjected to:
- Informed consent
- Full history taking, including age, duration of infertility and whether primary or secondary
- General and pelvix examination
- Trans-vaginal ultrasonography
- Determination of hormonal profile (FSH, LH, Estradiol, Prolactin)
- Determination of ovulatory status
- Determination of of tubal patency
- Determination of presence of male factor
- Determination of TSH and antithyroid antibodies (antithyroglobulin and antithyroid peroxidase) blood levels
Read the detailed description
The study population will be divided into three groups:
- Group (A) consisting of 40 infertile women with either unexplained or anovulatory infertility with/without associated male factor of infertility,
- Group (B) consisting of 40 infertile women with tubal (mechanical) factor of infertility with/without associated male factor of infertility, and
- Group (C) consisting of 40 women with exclusive male factor of infertility and will be used as a control group. . All women will be subjected to:
- Informed consent
- Full history taking, including age, duration of infertility and whether primary or secondary
- General and pelvix examination
- Trans-vaginal ultrasonography
- Determination of hormonal profile (FSH, LH, Estradiol, Prolactin)
- Determination of ovulatory status (by previous documented history of induction of ovulation OR previous ultrasonography OR previous estimation midluteal serum progesterone, etc …)
- Determination of of tubal patency (by previous hysterosalpingiography or laparoscopy)
- Determination of presence of male factor (by seminal fluid analysis)
- Determination of TSH and antithyroid antibodies (antithyroglobulin and antithyroid peroxidase) blood levels
- Conditions
- Infertility, Female
- Being tested
- Hormonal assay, Antibody assay
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hormonal assayDiagnostic test
Also called TSH assay
Measurement of Thyroid stimulating hormone
Antibody assayDiagnostic test
Also called antithyroid antibodies
antithyroglobulin and antithyroid peroxidase
| Study group | Role | What they receive |
|---|---|---|
| Anovulatory women | 40 infertile women with either unexplained or anovulatory infertility with/without associated male factor of infertility Receives: Diagnostic Test: Hormonal assay; Diagnostic Test: Antibody assay | |
| Tubal factor women | 40 infertile women with tubal (mechanical) factor of infertility with/without associated male factor of infertility Receives: Diagnostic Test: Hormonal assay; Diagnostic Test: Antibody assay | |
| male factor couple | 40 women with exclusive male factor of infertility and will be used as a control group Receives: Diagnostic Test: Hormonal assay; Diagnostic Test: Antibody assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of thyroid dysfunction among infertile women
prevalence of thyroid dysfunction (clinical or subclinical, hypothyroidism or hyperthyroidism) among infertile women
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study startMay 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed M Maged, MD, Cairo University
- Investigators
- Ahmed Maged, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03964779
- Sponsor's protocol ID
- 57
- Status last verified
- May 2019
- First submitted
- 23 May 2019
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Thyroid Dysfunction and Anti-thyroid Antibodies in Infertile Women
- ClinicalTrials.gov ID
- NCT03964779
- Acronym / sponsor ID
- 57
- Conditions
- Infertility, Female
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- May 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 28 May 2019 (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.
The study population will be divided into three groups:
- Group (A) consisting of 40 infertile women with either unexplained or anovulatory infertility with/without associated male factor of infertility,
- Group (B) consisting of 40 infertile women with tubal (mechanical) factor of infertility with/without associated male factor of infertility, and
- Group (C) consisting of 40 women with exclusive male factor of infertility and will be used as a control group. . All women will be subjected to:
- Informed consent
- Full history taking, including age, duration of infertility and whether primary or secondary
- General and pelvix examination
- Trans-vaginal ultrasonography
- Determination of hormonal profile (FSH, LH, Estradiol, Prolactin)
- Determination of ovulatory status
- Determination of of tubal patency
- Determination of presence of male factor
- Determination of TSH and antithyroid antibodies (antithyroglobulin and antithyroid peroxidase) blood levels
Detailed description
The study population will be divided into three groups:
- Group (A) consisting of 40 infertile women with either unexplained or anovulatory infertility with/without associated male factor of infertility,
- Group (B) consisting of 40 infertile women with tubal (mechanical) factor of infertility with/without associated male factor of infertility, and
- Group (C) consisting of 40 women with exclusive male factor of infertility and will be used as a control group. . All women will be subjected to:
- Informed consent
- Full history taking, including age, duration of infertility and whether primary or secondary
- General and pelvix examination
- Trans-vaginal ultrasonography
- Determination of hormonal profile (FSH, LH, Estradiol, Prolactin)
- Determination of ovulatory status (by previous documented history of induction of ovulation OR previous ultrasonography OR previous estimation midluteal serum progesterone, etc …)
- Determination of of tubal patency (by previous hysterosalpingiography or laparoscopy)
- Determination of presence of male factor (by seminal fluid analysis)
- Determination of TSH and antithyroid antibodies (antithyroglobulin and antithyroid peroxidase) blood levels
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anovulatory women | – | Diagnostic Test: Hormonal assay, Diagnostic Test: Antibody assay40 infertile women with either unexplained or anovulatory infertility with/without associated male factor of infertility |
| Tubal factor women | – | Diagnostic Test: Hormonal assay, Diagnostic Test: Antibody assay40 infertile women with tubal (mechanical) factor of infertility with/without associated male factor of infertility |
| male factor couple | – | Diagnostic Test: Hormonal assay, Diagnostic Test: Antibody assay40 women with exclusive male factor of infertility and will be used as a control group |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- 120 women with infertility will be divided into three groups: * Group (A) consisting of 40 infertile women with either unexplained or anovulatory infertility with/without associated male factor of infertility, * Group (B) consisting of 40 infertile women with tubal (mechanical) factor of infertility with/without associated male factor of infertility, and * Group (C) consisting of 40 women with exclusive male factor of infertility and will be used as a control group.
Key inclusion criteria (2 listed)
- - Age: 18 - 38 years
- Infertile women whether due to functional, anatomical, male factors OR unexplained OR combined factors
Key exclusion criteria (5 listed)
- - Age: below 18 and above 38 years
- Patients with autoimmune diseases (such as lupus and rheumatoid arthritis)
- Acute illness that require hospitalization
- Patients on the following medications: steroids, dopamine, iodine, amiodarone, lithium, donperidone, thyroid hormone, and phenytoin.
- Patients who work at night.
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 |
|---|---|---|
| Hormonal assayAlso: TSH assayMeasurement of Thyroid stimulating hormone | Diagnostic test | Anovulatory women, Tubal factor women, male factor couple |
| Antibody assayAlso: antithyroid antibodiesantithyroglobulin and antithyroid peroxidase | Diagnostic test | Anovulatory women, Tubal factor women, male factor couple |
Primary outcome
prevalence of thyroid dysfunction among infertile women
Time frame: through study completion, an average of 6 months
prevalence of thyroid dysfunction (clinical or subclinical, hypothyroidism or hyperthyroidism) among infertile women
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
- Individual participant dataSharing planned: Undecided
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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.
Ahmed Maged principal investigator
Professor
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 Infertility, Female, run by Cairo 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 2 inclusion and 5 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 28 May 2019. 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 Ahmed Maged (+201005227404, prof.ahmedmaged@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of thyroid dysfunction among infertile women (time frame: through study completion, an average of 6 months). 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 28 May 2019.