Sub Clinical HypothyroidismNCT03712683
Thyroxin in Subclinical Hypothyroidism
A study testing Thyroxine in people with Sub Clinical Hypothyroidism and Pregnancy Loss, run by Hawler Medical University.
Trial summary
Subclinical hypothyroidism(SCH) is the elevated thyroid stimulating hormone (TSH) with normal free Thyroxine levels and it is a mild or compensated form of primary hypothyroidism. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Sub Clinical Hypothyroidism, Pregnancy Loss
- What is being tested?
- Thyroxine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 1 Jul 2017
- Phase
- Interventional
- 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 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Unexplained infertility
- TSH more than 2.5 and normal T3,T4 levels
- Negative for Anti-thyroid antibodies
Who cannot join
- current history of overt hypo or hyperthyroidism
- recurrent pregnancy loss
- women having franked causes for infertility like tubal blockage, pelvic inflammatory disease, endometriosis , ,uterine factor
- Ovarian dysfunction or decreased ovarian reserve
- abnormal seminal fluid analysis or male factor
About this study
Official title: Prevalence of Subclinical Hypothyroidism in Women With Unexplained Infertility and the Effect of Thyroxin on Pregnancy Rate
Subclinical hypothyroidism(SCH) is the elevated thyroid stimulating hormone (TSH) with normal free Thyroxine levels and it is a mild or compensated form of primary hypothyroidism. It has been suggested that SCH is more prevalent in infertile women (especially in women with ovulatory disorders.Various rates of SCH was reported in infertile women in different populations
Read the detailed description
Despite well-established recommendations on screening and treatment of overt hypothyroid in infertile women, there is a controversy regard the treatment of SCH in infertile women .
There are few published data on the prevalence of SCH and the outcome of treatment of SCH in infertile women, many were conducted during IVF cycles . Moreover there are inconsistent results in these studies being authors advised to treat SCH before IVF and some other articles find out no any benefit regarding treatment with Thyroxine in SCH
- Conditions
- Sub Clinical Hypothyroidism, Pregnancy Loss
- Being tested
- Thyroxine
- Keywords
- Unexplained Infertility, pregnancy rate,hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThyroxineDrug
Also called Euthyrox
Thyroxine was prescribed with the diagnosis of SCH and continued when pregnancy was confirmed
| Study group | Role | What they receive |
|---|---|---|
| Sub clinical hypothyroid women | Experimental | Levothyroxine sodium(Euthyrox 50µg and 25 µg MerckSerono) treatment was initiated and the women were followed in a combined clinic of endocrinologist and Gynecologist.
2.5 µg of Thyroxine daily was prescribed to women with TSH more than 2.5 mIU/L. Women with TSH more than 4mIU/L were given 50 µg daily . When pregnancy was confirmed Thyroxine was continued till 13 weeks gestation . Receives: Drug: Thyroxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy
Pregnancy was confirmed using human chorionic gonadotropin hormone (hCG) estimation from blood
Measured: 2 years
Secondary outcomes (1)
Miscarriage rate
viability and growth of embryos were confirmed by ultrasound
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start1 Sep 2016
- Primary completion1 Jul 2017
- Study completion1 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sub Clinical HypothyroidismStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hawler Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ariana Jawad, Hawler Medical University
- Investigators
- Ariana Kh. Jawad, CABOG, Principal investigator, Hawler Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712683
- Sponsor's protocol ID
- HawlerMU2
- Status last verified
- Oct 2018
- First submitted
- 17 Oct 2018
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data of the research can be applied on request
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Subclinical Hypothyroidism in Women With Unexplained Infertility and the Effect of Thyroxin on Pregnancy Rate
- ClinicalTrials.gov ID
- NCT03712683
- Acronym / sponsor ID
- HawlerMU2
- Conditions
- Sub Clinical Hypothyroidism, Pregnancy Loss
- Keywords
- Unexplained Infertility, pregnancy rate,hypothyroidism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Hawler Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 19 Oct 2018 (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.
Subclinical hypothyroidism(SCH) is the elevated thyroid stimulating hormone (TSH) with normal free Thyroxine levels and it is a mild or compensated form of primary hypothyroidism. It has been suggested that SCH is more prevalent in infertile women (especially in women with ovulatory disorders.Various rates of SCH was reported in infertile women in different populations
Detailed description
Despite well-established recommendations on screening and treatment of overt hypothyroid in infertile women, there is a controversy regard the treatment of SCH in infertile women .
There are few published data on the prevalence of SCH and the outcome of treatment of SCH in infertile women, many were conducted during IVF cycles . Moreover there are inconsistent results in these studies being authors advised to treat SCH before IVF and some other articles find out no any benefit regarding treatment with Thyroxine in SCH
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sub clinical hypothyroid women | Experimental | Drug: ThyroxineLevothyroxine sodium(Euthyrox 50µg and 25 µg MerckSerono) treatment was initiated and the women were followed in a combined clinic of endocrinologist and Gynecologist. 2.5 µg of Thyroxine daily was prescribed to women with TSH more than 2.5 mIU/L. Women with TSH more than 4mIU/L were given 50 µg daily . When pregnancy was confirmed Thyroxine was continued till 13 weeks gestation . |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Unexplained infertility
- TSH more than 2.5 and normal T3,T4 levels
- Negative for Anti-thyroid antibodies
Key exclusion criteria (5 listed)
- current history of overt hypo or hyperthyroidism
- recurrent pregnancy loss
- women having franked causes for infertility like tubal blockage, pelvic inflammatory disease, endometriosis , ,uterine factor
- Ovarian dysfunction or decreased ovarian reserve
- abnormal seminal fluid analysis or male factor
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 |
|---|---|---|
| ThyroxineAlso: EuthyroxThyroxine was prescribed with the diagnosis of SCH and continued when pregnancy was confirmed | Drug | Sub clinical hypothyroid women |
Primary outcome
Pregnancy
Time frame: 2 years
Pregnancy was confirmed using human chorionic gonadotropin hormone (hCG) estimation from blood
1 secondary outcome
Miscarriage rate
Time frame: 13 weeks
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 29 Oct 2018.
- Individual participant dataSharing planned: No. Data of the research can be applied on request
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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.
Ariana Kh. Jawad, CABOG principal investigator
Hawler Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Thyroxine in people with Sub Clinical Hypothyroidism and Pregnancy Loss, run by Hawler Medical University.
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 3 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: finished, as of the sponsor's last update on 29 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Pregnancy (time frame: 2 years). 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 29 Oct 2018.