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

NCT03433768 — Completed, 67 participants, Aristotle University Of Thessaloniki
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Androgen Receptor (AR) mRNA Expression is Positively Associated With Live Birth in Women Undergoing In-vitro Fertilization Independently of the Type of Ovarian Response

RegistryNCT03433768
StatusCompleted
Study typeObservational
Enrollment67 (Actual)
SponsorAristotle University Of Thessaloniki (Other)
ConditionsAndrogen Receptor Gene Overexpression, Normal Responders, Poor Ovarian Response, Bologna Criteria
InterventionsReal time PCR (Genetic)
Datesstart 2014-09-14, primary completion 2017-10-10, completion 2018-01-10, first posted 2018-02-15, last updated 2018-02-15

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-Summary

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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+Arms and interventions

ArmTypeInterventionsDescription
poor respondersGenetic: Real time PCR
normal respondersGenetic: Real time PCR
  • 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.

+Outcome measures

Primary outcomes

  • Androgen Receptor mRNA expression [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

  • Serum LH levels in peripheral blood of normal and poor responders [day one, six and ten of ovarian stimulation]: level of hormone in international unit.
  • Serum progesterone levels in peripheral blood of normal and poor responders. [day one, six and ten of ovarian stimulation]: level of hormone in international unit.
  • Serum estradiol levels in peripheral blood of normal and poor responders [day one, six and ten of ovarian stimulation]: level of hormone in international unit.

+Eligibility

Sex: Female, ages: 20 Years to 42 Years

Inclusion Criteria:

* Women with poor ovarian response according to bologna criteria

  1. Advanced maternal age (≥40 years) or any other risk factor for poor ovarian response
  2. A previous poor ovarian response (≤3 oocytes with a conventional stimulation protocol)
  3. 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.

My Notes