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Completed

NCT Number: NCT03433768

Androgen Receptor mRNA Expression is Positively Associated With Live Birth in Women Undergoing IVF Independently of the Type of Ovarian Response

AR is a steroid hormone receptor that regulates various genes' expression and affects cellular proliferation and differentiation. Androgens interact with AR, exert their paracrine action on granulosa cells and regulate gonadotropin synthesis, follicle development, oocyte maturation and corpus luteum function. Estrogens increase AR mRNA and testosterone binding site in uterine endometrium and leiomyoma. In human cancer cells, low estradiol increases AR levels, suggesting the estrogen/androgen ratio as a predictor of sex steroid response. AR mRNA expression is, also, regulated by progesterone. Although AR mRNA is expressed in the female reproductive tissues, its expression has never been studied in peripheral blood.

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Key information

Conditions

Androgen Receptor Gene Overexpression Bologna Criteria Normal Responders Poor Ovarian Response

Age range

20 year–42 year

Sex eligibility

Female

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women with poor ovarian response according to bologna criteria
  • Advanced maternal age (≥40 years) or any other risk factor for poor ovarian response
  • A previous poor ovarian response (≤3 oocytes with a conventional stimulation protocol)
  • Abnormal ovarian reserve test, (AFC ˂5-7 follicles or AMH ˂0.5-1.1 ng/ml).
  • Women with normal ovarian response with normal menstrual cycles, normal astral follicle count and normal hormonal assay.

Exclusion criteria

  • Not more than 43 years old.
  • No history of malignancies, endometriosis or polycystic ovary syndrome.
  • Underlying genetic cause of infertility
  • History of severe cardiac, hepatic or renal disease.
  • History of systemic disease or treatment during the last three (3) months
  • Participation in another interventional study and a likelihood of being unavailable for follow-up.

Treatment and study plan

Real time PCR

Genetic

We take peripheral blood sample at day one, six and ten of ovarian stimulation and measure mRNA expression of androgen receptor.

Primary outcomes

  1. Androgen Receptor mRNA expression

    Time frame: day one, six and ten of ovarian stimulation

    The expression of androgen receptor mRNA in peripheral blood of normal and poor responders level of expression in peripheral blood according to the Delta-Delta-Ct (ddCt) Algorithm.

    Percentage of increase?

Secondary outcomes

  1. Serum LH levels in peripheral blood of normal and poor responders

    Time frame: day one, six and ten of ovarian stimulation

    level of hormone in international unit.

  2. Serum progesterone levels in peripheral blood of normal and poor responders.

    Time frame: day one, six and ten of ovarian stimulation

    level of hormone in international unit.

  3. Serum estradiol levels in peripheral blood of normal and poor responders

    Time frame: day one, six and ten of ovarian stimulation

    level of hormone in international unit.

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Official study title

Androgen Receptor (AR) mRNA Expression is Positively Associated With Live Birth in Women Undergoing In-vitro Fertilization Independently of the Type of Ovarian Response

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Feb 15, 2018
Registry last updated
Feb 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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