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

NCT ID: NCT03433768

Last Updated: 2018-02-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 67 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-09-14
• Study Completion Date: 2018-01-10

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.

Conditions

Androgen Receptor Gene Overexpression; Normal Responders; Poor Ovarian Response; Bologna Criteria

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

poor responders

Real time PCR

Intervention Type: GENETIC

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

normal responders

Real time PCR

Intervention Type: GENETIC

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

Interventions

Real time PCR

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

Intervention Type: GENETIC

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Aristotle University Of Thessaloniki

OTHER

Sponsor Role: lead

Responsible Party

E.M. Kolibianakis

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

UHR 13

Identifier Type: -

Identifier Source: org_study_id