ClinicalTrials.gov
ClinicalTrials.gov Menu

Tachykinin and Kisspeptin Expression in Human Granulosa and Cumulus Cells

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02877992
Recruitment Status : Recruiting
First Posted : August 25, 2016
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Manuel Fernandez-Sanchez, IVI Sevilla

Brief Summary:
The purpose of this project is to study the presence of expression differences - at RNA and protein level - of different members of the tachykinin family and kisspeptin and their receptors, between fertile women and infertile patients with different etiologies.

Condition or disease Intervention/treatment Phase
Infertility Procedure: Ovarian puncture Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Development of a New Diagnostic Tool to Assess Oocyte Quality Based on Tachykinin and Kisspeptin Expression Analysis in Human Granulosa and Cumulus Cells
Study Start Date : January 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
Active Comparator: Donors
Oocyte donors without infertility problems
Procedure: Ovarian puncture
Donors and patients are subjected to ovarian puncture as part of their donation procedure or IVF treatment. Oocyte are retrieved in this procedure along with granulosa and cumulus cells. Donors and patients sign an informed consent in order to donate their granulosa and cumulus cells for the study.

Experimental: PCOS
Patients with Polycystic Ovary Syndrome (PCOS) according to Rotterdam criteria
Procedure: Ovarian puncture
Donors and patients are subjected to ovarian puncture as part of their donation procedure or IVF treatment. Oocyte are retrieved in this procedure along with granulosa and cumulus cells. Donors and patients sign an informed consent in order to donate their granulosa and cumulus cells for the study.

Experimental: Endometriosis
Patients with endometriosis (I-IV)
Procedure: Ovarian puncture
Donors and patients are subjected to ovarian puncture as part of their donation procedure or IVF treatment. Oocyte are retrieved in this procedure along with granulosa and cumulus cells. Donors and patients sign an informed consent in order to donate their granulosa and cumulus cells for the study.

Experimental: Age
Patients with advanced maternal age (38 years or more)
Procedure: Ovarian puncture
Donors and patients are subjected to ovarian puncture as part of their donation procedure or IVF treatment. Oocyte are retrieved in this procedure along with granulosa and cumulus cells. Donors and patients sign an informed consent in order to donate their granulosa and cumulus cells for the study.

Experimental: Low ovarian response
Patients with low ovarian response according to Bologna criteria
Procedure: Ovarian puncture
Donors and patients are subjected to ovarian puncture as part of their donation procedure or IVF treatment. Oocyte are retrieved in this procedure along with granulosa and cumulus cells. Donors and patients sign an informed consent in order to donate their granulosa and cumulus cells for the study.




Primary Outcome Measures :
  1. Expression level of Substance P (SP) [ Time Frame: 4 years ]
    Expression analysis at mRNA (mRNA = messenger ribonucleic acid) and protein level using techniques of real time quantitative PCR (PCR = polymerase chain reaction), immunocytochemistry and western blot

  2. Expression level of neurokinin A (NKA) [ Time Frame: 4 years ]
    Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot

  3. Expression level of neurokinin B (NKB) [ Time Frame: 4 years ]
    Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot

  4. Expression level of hemokinin 1 (HK-1) [ Time Frame: 4 years ]
    Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot

  5. Expression level of neurokinin 1 receptor (NK1R) [ Time Frame: 4 years ]
    Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot

  6. Expression of neurokinin 2 receptor (NK2R) [ Time Frame: 4 years ]
    Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot

  7. Expression level of neurokinin 3 receptor (NK3R) [ Time Frame: 4 years ]
    Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot

  8. Expression level of kisspeptin 1 (KISS1) [ Time Frame: 4 years ]
    Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot

  9. Expression level of kisspeptin 1 receptor (KISS1R) [ Time Frame: 4 years ]
    Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot


Secondary Outcome Measures :
  1. Patient or donor age [ Time Frame: 4 years ]
    Years

  2. Patient or donor body mass index [ Time Frame: 4 years ]
    kg/m2

  3. Years of infertility [ Time Frame: 4 years ]
    Number of years that the patient has been trying to have a child without success

  4. Estradiol level (day of ovulation induction) [ Time Frame: 4 years ]
    Estradiol level in blood (pg/mL), measured the day in which ovulation is induced

  5. Progesterone level (day of ovulation induction) [ Time Frame: 4 years ]
    Progesterone level in blood (ng/mL), measured the day in which ovulation is induced

  6. Number of oocytes retrieved in the ovarian puncture [ Time Frame: 4 years ]
  7. Number of mature oocytes (metaphase II) obtained in the ovarian puncture [ Time Frame: 4 years ]
  8. Fertilization rate [ Time Frame: 4 years ]
    Proportion of oocytes correctly fertilized (2 pronuclei and 2 polar bodies) after the ICSI (ICSI = intracytoplasmic sperm injection) procedure

  9. Embryo quality [ Time Frame: 4 years ]
    Embryo quality at day 3 of embryo development (of each embryo of the cohort). Quality assessed according to ASEBIR (ASEBIR = "Asociación Española para el estudio de la Biología de la Reproducción" = Spanish society for reproductive biology) criteria. Embryo quality grade A to D.

  10. Daily and total dose of FSH (FSH = follicle stimulating hormone) [ Time Frame: 4 years ]
    Daily dose of FSH for controlled ovarian stimulation. International Units (IU)

  11. Daily and total dose of HMG (HMG = human menopausal gonadotropin) [ Time Frame: 4 years ]
    Daily dose of HMG for controlled ovarian stimulation. International Units (IU)

  12. Type of ovulation induction [ Time Frame: 4 years ]
    Ovulation induction using 6500 IU of hCG (hCG = human chorionic gonadotropin) or 0.2 mg of triptorelin (Decapeptyl)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Two groups of subjects (each one with different criteria):

  1. Oocyte donors

    Inclusion Criteria:

    • Age between 18 and 34 years
    • Normal caryotype
    • Normal psychological test

    Exclusion Criteria:

    • Presence of hereditary diseases
    • Beta-thalassemia
    • Cystic fibrosis
    • Human immunodeficiency virus (HIV), Hepatitis B virus (HBV), Hepatitis C virus (HCV)
  2. Infertility patients

Inclusion Criteria:

  • Age between 18 and 45 years
  • One of the following etiologies:
  • Patient with PCOS according to Rotterdam Criteria or
  • Patients with endometriosis stage I-IV or
  • Patients with low ovarian response according to Bologna criteria or
  • Patients with advances maternal age (between 38 and 45 years)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02877992


Contacts
Contact: Víctor Blasco, MSc +34 954 286 274 ext 19523 victor.blasco@ivi.es

Locations
Spain
Instituto de Investigaciones Químicas Recruiting
Sevilla, Spain, 41011
Contact: Luz Candenas, PhD         
IVI Sevilla Recruiting
Sevilla, Spain, 41011
Contact: Víctor Blasco, MSc    +34 954 286 274 ext 19523    victor.blasco@ivi.es   
Sponsors and Collaborators
IVI Sevilla

Publications of Results:
Other Publications:
Responsible Party: Manuel Fernandez-Sanchez, Dr, IVI Sevilla
ClinicalTrials.gov Identifier: NCT02877992     History of Changes
Other Study ID Numbers: IVISEVILLA
First Posted: August 25, 2016    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018

Keywords provided by Manuel Fernandez-Sanchez, IVI Sevilla:
Infertility
Tachykinin
Kisspeptin

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Tachykinins
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs