Tachykinin and Kisspeptin Expression in Human Granulosa and Cumulus Cells

Sponsor
IVI Sevilla (Other)
Overall Status
Completed
CT.gov ID
NCT02877992
Collaborator
(none)
236
2
5
65.9
118
1.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Ovarian puncture
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
236 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 :
Jan 1, 2014
Actual Primary Completion Date :
Jul 1, 2019
Actual Study Completion Date :
Jul 1, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Expression level of Substance P (SP) [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) [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) [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) [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) [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) [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) [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) [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) [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 [4 years]

    Years

  2. Patient or donor body mass index [4 years]

    kg/m2

  3. Years of infertility [4 years]

    Number of years that the patient has been trying to have a child without success

  4. Estradiol level (day of ovulation induction) [4 years]

    Estradiol level in blood (pg/mL), measured the day in which ovulation is induced

  5. Progesterone level (day of ovulation induction) [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 [4 years]

  7. Number of mature oocytes (metaphase II) obtained in the ovarian puncture [4 years]

  8. Fertilization rate [4 years]

    Proportion of oocytes correctly fertilized (2 pronuclei and 2 polar bodies) after the ICSI (ICSI = intracytoplasmic sperm injection) procedure

  9. Embryo quality [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) [4 years]

    Daily dose of FSH for controlled ovarian stimulation. International Units (IU)

  11. Daily and total dose of HMG (HMG = human menopausal gonadotropin) [4 years]

    Daily dose of HMG for controlled ovarian stimulation. International Units (IU)

  12. Type of ovulation induction [4 years]

    Ovulation induction using 6500 IU of hCG (hCG = human chorionic gonadotropin) or 0.2 mg of triptorelin (Decapeptyl)

Eligibility Criteria

Criteria

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

  1. 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Instituto de Investigaciones Químicas Sevilla Spain 41011
2 IVI Sevilla Sevilla Spain 41011

Sponsors and Collaborators

  • IVI Sevilla

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Manuel Fernandez-Sanchez, Dr, IVI Sevilla
ClinicalTrials.gov Identifier:
NCT02877992
Other Study ID Numbers:
  • IVISEVILLA
First Posted:
Aug 25, 2016
Last Update Posted:
Feb 13, 2020
Last Verified:
Feb 1, 2020
Keywords provided by Manuel Fernandez-Sanchez, Dr, IVI Sevilla
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 13, 2020