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

Androgen Receptor (AR) mRNA Expression is Positively Associated With Live Birth in Women Undergoing In-vitro Fertilization 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.

Study Overview

• Status: Completed
• Conditions: Poor Ovarian Response; Androgen Receptor Gene Overexpression; Normal Responders; Bologna Criteria
• Intervention / Treatment: Genetic: Real time PCR

• Study Type: Observational
• Enrollment (Actual): 67

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 42 years (ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Forty normal responders and twenty-seven poor responders according to Bologna criteria, undergoing IVF/ICSI. Ovarian stimulation was performed with 200 IU recombinant follicle stimulating hormone (rFSH) and gonadotrophin releasing hormone (GnRH) antagonists. Triggering of final oocyte maturation was performed by recombinant human chorionic gonadotrophic (rhCG)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
poor responders	Genetic: Real time PCR; We take peripheral blood sample at day one, six and ten of ovarian stimulation and measure mRNA expression of androgen receptor.
normal responders	Genetic: Real time PCR; We take peripheral blood sample at day one, six and ten of ovarian stimulation and measure mRNA expression of androgen receptor.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Aristotle University Of Thessaloniki

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 14, 2014
• Primary Completion (ACTUAL): October 10, 2017
• Study Completion (ACTUAL): January 10, 2018

Study Registration Dates

• First Submitted: January 31, 2018
• First Submitted That Met QC Criteria: February 8, 2018
• First Posted (ACTUAL): February 15, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 15, 2018
• Last Update Submitted That Met QC Criteria: February 8, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: UHR 13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No