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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Androgen Receptor Gene Overexpression, Normal Responders, Poor Ovarian Response, Bologna Criteria

Intervention / Treatment
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* Genetic: Real time PCR


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| poor responders<br> | Genetic: Real time PCR<br>* We take peripheral blood sample at day one, six and ten of ovarian stimulation and measure mRNA expression of androgen receptor.<br>|
| normal responders<br> | Genetic: Real time PCR<br>* We take peripheral blood sample at day one, six and ten of ovarian stimulation and measure mRNA expression of androgen receptor.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Androgen Receptor mRNA expression | 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? | day one, six and ten of ovarian stimulation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum LH levels in peripheral blood of normal and poor responders | level of hormone in international unit. | day one, six and ten of ovarian stimulation | 
| Serum progesterone levels in peripheral blood of normal and poor responders. | level of hormone in international unit. | day one, six and ten of ovarian stimulation | 
| Serum estradiol levels in peripheral blood of normal and poor responders | level of hormone in international unit. | day one, six and ten of ovarian stimulation |