TSH And AMH in Infertile Women

March 11, 2016 updated by: Haitham Hassan Ahmed, Ain Shams Maternity Hospital

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.

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Ain shams maternity patients in infertility unit

Description

Inclusion Criteria:

  1. Age: 20-35 years
  2. Diagnosed as primary infertility.
  3. Duration of marriage more than 1 year.
  4. Controls should be normal fertile women aged 20- 35 years had no history of treatment for infertility or thyroid disorders.

Exclusion Criteria:

  1. Age: above 35 years old.
  2. Women with ovarian dysfunction (PCO, post ovarian surgery).
  3. Treated thyroid dysfunction (Autoimmune thyroiditis, hypothyroidism).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
TSH Levels in mIU/L
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

August 1, 2016

Study Registration Dates

First Submitted

December 30, 2015

First Submitted That Met QC Criteria

March 11, 2016

First Posted (Estimate)

March 16, 2016

Study Record Updates

Last Update Posted (Estimate)

March 16, 2016

Last Update Submitted That Met QC Criteria

March 11, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HAhmed

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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