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Tachykinin and Kisspeptin Expression in Human Granulosa and Cumulus Cells

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Ovarian puncture
Sponsored by
IVI Sevilla
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Infertility focused on measuring Infertility, Tachykinin, Kisspeptin

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Instituto de Investigaciones Químicas
  • IVI Sevilla

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Donors

PCOS

Endometriosis

Age

Low ovarian response

Arm Description

Oocyte donors without infertility problems

Patients with Polycystic Ovary Syndrome (PCOS) according to Rotterdam criteria

Patients with endometriosis (I-IV)

Patients with advanced maternal age (38 years or more)

Patients with low ovarian response according to Bologna criteria

Outcomes

Primary Outcome Measures

Expression level of Substance P (SP)
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
Expression level of neurokinin A (NKA)
Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot
Expression level of neurokinin B (NKB)
Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot
Expression level of hemokinin 1 (HK-1)
Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot
Expression level of neurokinin 1 receptor (NK1R)
Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot
Expression of neurokinin 2 receptor (NK2R)
Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot
Expression level of neurokinin 3 receptor (NK3R)
Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot
Expression level of kisspeptin 1 (KISS1)
Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot
Expression level of kisspeptin 1 receptor (KISS1R)
Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot

Secondary Outcome Measures

Patient or donor age
Years
Patient or donor body mass index
kg/m2
Years of infertility
Number of years that the patient has been trying to have a child without success
Estradiol level (day of ovulation induction)
Estradiol level in blood (pg/mL), measured the day in which ovulation is induced
Progesterone level (day of ovulation induction)
Progesterone level in blood (ng/mL), measured the day in which ovulation is induced
Number of oocytes retrieved in the ovarian puncture
Number of mature oocytes (metaphase II) obtained in the ovarian puncture
Fertilization rate
Proportion of oocytes correctly fertilized (2 pronuclei and 2 polar bodies) after the ICSI (ICSI = intracytoplasmic sperm injection) procedure
Embryo quality
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.
Daily and total dose of FSH (FSH = follicle stimulating hormone)
Daily dose of FSH for controlled ovarian stimulation. International Units (IU)
Daily and total dose of HMG (HMG = human menopausal gonadotropin)
Daily dose of HMG for controlled ovarian stimulation. International Units (IU)
Type of ovulation induction
Ovulation induction using 6500 IU of hCG (hCG = human chorionic gonadotropin) or 0.2 mg of triptorelin (Decapeptyl)

Full Information

First Posted
August 12, 2016
Last Updated
February 11, 2020
Sponsor
IVI Sevilla
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1. Study Identification

Unique Protocol Identification Number
NCT02877992
Brief Title
Tachykinin and Kisspeptin Expression in Human Granulosa and Cumulus Cells
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 Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
July 2019 (Actual)
Study Completion Date
July 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IVI Sevilla

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Infertility, Tachykinin, Kisspeptin

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
236 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Donors
Arm Type
Active Comparator
Arm Description
Oocyte donors without infertility problems
Arm Title
PCOS
Arm Type
Experimental
Arm Description
Patients with Polycystic Ovary Syndrome (PCOS) according to Rotterdam criteria
Arm Title
Endometriosis
Arm Type
Experimental
Arm Description
Patients with endometriosis (I-IV)
Arm Title
Age
Arm Type
Experimental
Arm Description
Patients with advanced maternal age (38 years or more)
Arm Title
Low ovarian response
Arm Type
Experimental
Arm Description
Patients with low ovarian response according to Bologna criteria
Intervention Type
Procedure
Intervention Name(s)
Ovarian puncture
Intervention Description
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 Measure Information:
Title
Expression level of Substance P (SP)
Description
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
Time Frame
4 years
Title
Expression level of neurokinin A (NKA)
Description
Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot
Time Frame
4 years
Title
Expression level of neurokinin B (NKB)
Description
Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot
Time Frame
4 years
Title
Expression level of hemokinin 1 (HK-1)
Description
Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot
Time Frame
4 years
Title
Expression level of neurokinin 1 receptor (NK1R)
Description
Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot
Time Frame
4 years
Title
Expression of neurokinin 2 receptor (NK2R)
Description
Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot
Time Frame
4 years
Title
Expression level of neurokinin 3 receptor (NK3R)
Description
Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot
Time Frame
4 years
Title
Expression level of kisspeptin 1 (KISS1)
Description
Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot
Time Frame
4 years
Title
Expression level of kisspeptin 1 receptor (KISS1R)
Description
Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Patient or donor age
Description
Years
Time Frame
4 years
Title
Patient or donor body mass index
Description
kg/m2
Time Frame
4 years
Title
Years of infertility
Description
Number of years that the patient has been trying to have a child without success
Time Frame
4 years
Title
Estradiol level (day of ovulation induction)
Description
Estradiol level in blood (pg/mL), measured the day in which ovulation is induced
Time Frame
4 years
Title
Progesterone level (day of ovulation induction)
Description
Progesterone level in blood (ng/mL), measured the day in which ovulation is induced
Time Frame
4 years
Title
Number of oocytes retrieved in the ovarian puncture
Time Frame
4 years
Title
Number of mature oocytes (metaphase II) obtained in the ovarian puncture
Time Frame
4 years
Title
Fertilization rate
Description
Proportion of oocytes correctly fertilized (2 pronuclei and 2 polar bodies) after the ICSI (ICSI = intracytoplasmic sperm injection) procedure
Time Frame
4 years
Title
Embryo quality
Description
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.
Time Frame
4 years
Title
Daily and total dose of FSH (FSH = follicle stimulating hormone)
Description
Daily dose of FSH for controlled ovarian stimulation. International Units (IU)
Time Frame
4 years
Title
Daily and total dose of HMG (HMG = human menopausal gonadotropin)
Description
Daily dose of HMG for controlled ovarian stimulation. International Units (IU)
Time Frame
4 years
Title
Type of ovulation induction
Description
Ovulation induction using 6500 IU of hCG (hCG = human chorionic gonadotropin) or 0.2 mg of triptorelin (Decapeptyl)
Time Frame
4 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Two groups of subjects (each one with different criteria): 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) 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)
Facility Information:
Facility Name
Instituto de Investigaciones Químicas
City
Sevilla
ZIP/Postal Code
41011
Country
Spain
Facility Name
IVI Sevilla
City
Sevilla
ZIP/Postal Code
41011
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
25316443
Citation
Garcia-Ortega J, Pinto FM, Fernandez-Sanchez M, Prados N, Cejudo-Roman A, Almeida TA, Hernandez M, Romero M, Tena-Sempere M, Candenas L. Expression of neurokinin B/NK3 receptor and kisspeptin/KISS1 receptor in human granulosa cells. Hum Reprod. 2014 Dec;29(12):2736-46. doi: 10.1093/humrep/deu247. Epub 2014 Oct 14.
Results Reference
background
PubMed Identifier
27146034
Citation
Garcia-Ortega J, Pinto FM, Prados N, Bello AR, Almeida TA, Fernandez-Sanchez M, Candenas L. Expression of Tachykinins and Tachykinin Receptors and Interaction with Kisspeptin in Human Granulosa and Cumulus Cells. Biol Reprod. 2016 Jun;94(6):124. doi: 10.1095/biolreprod.116.139881. Epub 2016 May 4.
Results Reference
result

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Tachykinin and Kisspeptin Expression in Human Granulosa and Cumulus Cells

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