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Trial record 13 of 103 for:    "Kennedy disease"

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

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ClinicalTrials.gov Identifier: NCT03433768
Recruitment Status : Completed
First Posted : February 15, 2018
Last Update Posted : February 15, 2018
Sponsor:
Information provided by (Responsible Party):
E.M. Kolibianakis, 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.

Condition or disease Intervention/treatment
Androgen Receptor Gene Overexpression Normal Responders Poor Ovarian Response Bologna Criteria Genetic: Real time PCR

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Study Type : Observational [Patient Registry]
Actual Enrollment : 67 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 4 Weeks
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
Actual Study Start Date : September 14, 2014
Actual Primary Completion Date : October 10, 2017
Actual Study Completion Date : January 10, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Androgen Receptor mRNA expression [ Time Frame: 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 :
  1. Serum LH levels in peripheral blood of normal and poor responders [ Time Frame: day one, six and ten of ovarian stimulation ]
    level of hormone in international unit.

  2. Serum progesterone levels in peripheral blood of normal and poor responders. [ Time Frame: day one, six and ten of ovarian stimulation ]
    level of hormone in international unit.

  3. Serum estradiol levels in peripheral blood of normal and poor responders [ Time Frame: day one, six and ten of ovarian stimulation ]
    level of hormone in international unit.



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Ages Eligible for Study:   20 Years to 42 Years   (Adult)
Sexes 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)
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.

Additional Information:

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Responsible Party: E.M. Kolibianakis, Associate Professor, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT03433768     History of Changes
Other Study ID Numbers: UHR 13
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs