ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 29 of 1991 for:    infertility AND (woman OR women OR female)

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.
ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
Haitham Hassan Ahmed, Ain Shams Maternity Hospital

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.


Condition or disease Intervention/treatment
Infertility Other: serum TSH level

Study Type : Observational
Actual Enrollment : 2 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: TSH and AMH in Infertile Women
Study Start Date : December 2015
Estimated Primary Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility




Primary Outcome Measures :
  1. TSH Levels in mIU/L [ Time Frame: 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Ain shams maternity patients in infertility unit
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).

Responsible Party: Haitham Hassan Ahmed, Maghagha general hospital, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier: NCT02710175     History of Changes
Other Study ID Numbers: HAhmed
First Posted: March 16, 2016    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female