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TSH And AMH in Infertile Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02710175
Recruitment Status : Unknown
Verified March 2016 by Haitham Hassan Ahmed, Ain Shams Maternity Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : March 16, 2016
Last Update Posted : March 16, 2016
Information provided by (Responsible Party):
Haitham Hassan Ahmed, Ain Shams Maternity Hospital

Tracking Information
First Submitted Date December 30, 2015
First Posted Date March 16, 2016
Last Update Posted Date March 16, 2016
Study Start Date December 2015
Estimated Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 11, 2016)
TSH Levels in mIU/L [ Time Frame: 1 year ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title TSH And AMH in Infertile Women
Official Title TSH and AMH in Infertile Women
Brief 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.

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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Ain shams maternity patients in infertility unit
Condition Infertility
Intervention Other: serum TSH level
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Unknown status
Actual Enrollment
 (submitted: March 11, 2016)
Original Actual Enrollment Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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).
Sexes Eligible for Study: Female
Ages 20 Years to 35 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
Administrative Information
NCT Number NCT02710175
Other Study ID Numbers HAhmed
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Haitham Hassan Ahmed, Ain Shams Maternity Hospital
Study Sponsor Ain Shams Maternity Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Ain Shams Maternity Hospital
Verification Date March 2016