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

Completed

• Conditions: Androgen Receptor Gene Overexpression; Normal Responders; Bologna Criteria; Poor Ovarian Response
• Interventions: Genetic: Real time PCR

• Registration Number: NCT03433768
• Lead Sponsor: Aristotle University Of Thessaloniki

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-14
• Primary Completion: 2017-10-10
• Study Completion: 2018-01-10
• Study First Submitted: 2018-01-31
• Status Verified: 2018-02
• Study First Submitted QC: 2018-02-08
• Last Update Submitted: 2018-02-08
• Study First Posted: 2018-02-15
• Last Update Posted: 2018-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 67

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
normal responders	Real time PCR	-
poor responders	Real time PCR	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.