Tachykinin and Kisspeptin Expression in Human Granulosa and Cumulus Cells

February 11, 2020 updated by: Manuel Fernandez-Sanchez, IVI Sevilla

Development of a New Diagnostic Tool to Assess Oocyte Quality Based on Tachykinin and Kisspeptin Expression Analysis 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
236

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Sevilla, Spain, 41011
        • IVI Sevilla
      • Sevilla, Spain, 41011
        • Instituto de Investigaciones Químicas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
4 years
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
4 years
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 years
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
4 years
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
4 years
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
4 years
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
4 years
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
4 years
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
4 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient or donor age
Time Frame: 4 years
Years
4 years
Patient or donor body mass index
Time Frame: 4 years
kg/m2
4 years
Years of infertility
Time Frame: 4 years
Number of years that the patient has been trying to have a child without success
4 years
Estradiol level (day of ovulation induction)
Time Frame: 4 years
Estradiol level in blood (pg/mL), measured the day in which ovulation is induced
4 years
Progesterone level (day of ovulation induction)
Time Frame: 4 years
Progesterone level in blood (ng/mL), measured the day in which ovulation is induced
4 years
Number of oocytes retrieved in the ovarian puncture
Time Frame: 4 years
4 years
Number of mature oocytes (metaphase II) obtained in the ovarian puncture
Time Frame: 4 years
4 years
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
4 years
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.
4 years
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)
4 years
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)
4 years
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)
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IVI Sevilla

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 12, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 13, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IVISEVILLA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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