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

NCT03433768 | Completed

• 1 other identifier: UHR 13
• Study Type: observational
• Target: 67
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Serum LH levels in peripheral blood of normal and poor responders

  day one, six and ten of ovarian stimulation

• Serum progesterone levels in peripheral blood of normal and poor responders.

  day one, six and ten of ovarian stimulation

• Serum estradiol levels in peripheral blood of normal and poor responders

  day one, six and ten of ovarian stimulation

Study Arms (2)

poor responders

Genetic: Real time PCR

normal responders

Genetic: Real time PCR

Interventions

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.

normal responders; poor responders

Eligibility Criteria

• Age: 20 Years - 42 Years
• Sex: female
• Age Groups: Adult (18-64)
• 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)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

MeSH Terms

Interventions

Real-Time Polymerase Chain Reaction

Intervention Hierarchy (Ancestors)

Polymerase Chain Reaction; Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: February 15, 2018
• Study Start: September 14, 2014
• Primary Completion: October 10, 2017
• Study Completion: January 10, 2018
• Last Updated: February 15, 2018

Record last verified: 2018-02