Skip to main content
OpenTrials
Completed

NCT Number: NCT02877992

Tachykinin and Kisspeptin Expression in Human Granulosa and Cumulus Cells

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

IVI Sevilla, Seville, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ovarian puncture

Procedure

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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Vida Recoletas Sevilla

Other

Registry information

Official study title

Development of a New Diagnostic Tool to Assess Oocyte Quality Based on Tachykinin and Kisspeptin Expression Analysis in Human Granulosa and Cumulus Cells

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Aug 25, 2016
Registry last updated
Feb 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.