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

Poor Ovarian Response Clinical Trial

Official title:

Androgen Receptor (AR) mRNA Expression is Positively Associated With Live Birth in Women Undergoing In-vitro Fertilization Independently of the Type of Ovarian Response

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03433768
• Other study ID #: UHR 13
• Status: Completed
• Phase: N/A
• First received: January 31, 2018
• Last updated: February 8, 2018
• Start date: September 14, 2014
• Est. completion date: January 10, 2018

Study information

• Verified date: February 2018
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: January 10, 2018
• Est. primary completion date: October 10, 2017
• Gender: Female
• Age group: 20 Years to 42 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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