InfertilityNCT02710175
TSH And AMH in Infertile Women
An observational study of Infertility, run by Ain Shams Maternity Hospital.
Trial summary
Infertility is defined as the inability of a couple to achieve pregnancy over an average period of one year (in women under 35 years of age) or 6 months (in women above 35 years of age) of unprotected sexual intercourse. Infertility can be due to female, male reasons or both. It can be either primary or secondary. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- serum TSH level
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Aug 2016
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Ain shams maternity patients in infertility unit
Who may be able to join
- Age: 20-35 years
- Diagnosed as primary infertility.
- Duration of marriage more than 1 year.
- Controls should be normal fertile women aged 20- 35 years had no history of treatment for infertility or thyroid disorders.
Who cannot join
- Age: above 35 years old.
- Women with ovarian dysfunction (PCO, post ovarian surgery).
- Treated thyroid dysfunction (Autoimmune thyroiditis, hypothyroidism).
About this study
Official title: TSH and AMH in Infertile Women
Infertility is defined as the inability of a couple to achieve pregnancy over an average period of one year (in women under 35 years of age) or 6 months (in women above 35 years of age) of unprotected sexual intercourse. Infertility can be due to female, male reasons or both. It can be either primary or secondary.
Thyroid dysfunction and autoimmune thyroiditis are known adverse risk factors for pregnancy as well as fertility, regardless of the presence of disease in women of reproductive age. In particular, hypothyroid women are at an increased risk of menstrual disorders and infertility because of altered peripheral estrogen metabolism, hyperprolactinaemia and abnormal release of gonadotropin-releasing hormone.
Read more
The prevalence of subclinical hypothyroidism characterized by aberrant high serum thyroid-stimulating hormone (TSH) levels with normal free thyroxin (FT4) levels in infertile women are reported to be approximately 20% and it is a primary cause of subfertility.
Indeed, average TSH levels in infertile women were reportedly higher than those in normal fertile women. And elevated serum TSH levels were associated with diminished ovarian reserve in infertile patients. Moreover, although levothyroxine replacement therapy for subclinical hypothyroidism in infertile patients remains debatable, thyroxin supplementation may improve fertility to successful pregnancy.
This data suggests that hypothyroidism is strongly correlated with infertility (Velkeniers et al., 2013).
On the other hand, female fecundity decreases with increasing age, primarily because of decreased ovarian function. Anti-mullerian hormone (AMH) is a dimeric glycoprotein belonging to the transforming growth factor-beta (TGF-B) super family, which act on tissue growth and differentiation. It is produced by the granulosa cells from pre-antral and small antral follicles. Ovarian research after oophorectomy showed that serum AMH levels were closely correlated with the number of primordial follicles; therefore, AMH is a suitable biomarker of ovarian age in women of reproductive age.
Expectedly, ovarian function may be affected by impaired thyroid function, although this association has not been elucidated. In this study, we will evaluate the relationship between thyroid function and AMH levels by comparing them in infertile patients and healthy fertile women.
- Conditions
- Infertility
- Being tested
- serum TSH level
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum TSH levelOther
What is being measured
The primary outcome is the main question the study is designed to answer.
TSH Levels in mIU/L
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2016 (estimated)
- Study startDec 2015
- Primary completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haitham Hassan Ahmed, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02710175
- Sponsor's protocol ID
- HAhmed
- Status last verified
- Mar 2016
- First submitted
- 30 Dec 2015
- Last updated
- 16 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TSH and AMH in Infertile Women
- ClinicalTrials.gov ID
- NCT02710175
- Acronym / sponsor ID
- HAhmed
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Aug 2016 (estimated)
- First posted
- 16 Mar 2016 (estimated)
- 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.
Infertility is defined as the inability of a couple to achieve pregnancy over an average period of one year (in women under 35 years of age) or 6 months (in women above 35 years of age) of unprotected sexual intercourse. Infertility can be due to female, male reasons or both. It can be either primary or secondary.
Thyroid dysfunction and autoimmune thyroiditis are known adverse risk factors for pregnancy as well as fertility, regardless of the presence of disease in women of reproductive age. In particular, hypothyroid women are at an increased risk of menstrual disorders and infertility because of altered peripheral estrogen metabolism, hyperprolactinaemia and abnormal release of gonadotropin-releasing hormone.
The prevalence of subclinical hypothyroidism characterized by aberrant high serum thyroid-stimulating hormone (TSH) levels with normal free thyroxin (FT4) levels in infertile women are reported to be approximately 20% and it is a primary cause of subfertility.
Indeed, average TSH levels in infertile women were reportedly higher than those in normal fertile women. And elevated serum TSH levels were associated with diminished ovarian reserve in infertile patients. Moreover, although levothyroxine replacement therapy for subclinical hypothyroidism in infertile patients remains debatable, thyroxin supplementation may improve fertility to successful pregnancy.
This data suggests that hypothyroidism is strongly correlated with infertility (Velkeniers et al., 2013).
On the other hand, female fecundity decreases with increasing age, primarily because of decreased ovarian function. Anti-mullerian hormone (AMH) is a dimeric glycoprotein belonging to the transforming growth factor-beta (TGF-B) super family, which act on tissue growth and differentiation. It is produced by the granulosa cells from pre-antral and small antral follicles. Ovarian research after oophorectomy showed that serum AMH levels were closely correlated with the number of primordial follicles; therefore, AMH is a suitable biomarker of ovarian age in women of reproductive age.
Expectedly, ovarian function may be affected by impaired thyroid function, although this association has not been elucidated. In this study, we will evaluate the relationship between thyroid function and AMH levels by comparing them in infertile patients and healthy fertile women.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Ain shams maternity patients in infertility unit
Key inclusion criteria (4 listed)
- Age: 20-35 years
- Diagnosed as primary infertility.
- Duration of marriage more than 1 year.
- Controls should be normal fertile women aged 20- 35 years had no history of treatment for infertility or thyroid disorders.
Key exclusion criteria (3 listed)
- Age: above 35 years old.
- Women with ovarian dysfunction (PCO, post ovarian surgery).
- Treated thyroid dysfunction (Autoimmune thyroiditis, hypothyroidism).
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 |
|---|---|---|
| serum TSH level | Other | – |
Primary outcome
TSH Levels in mIU/L
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Ain Shams Maternity Hospital.
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 3 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 16 Mar 2016. 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?
Results are not available in the source record.
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?
TSH Levels in mIU/L (time frame: 1 year). 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 16 Mar 2016.