NCT02877992

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
236

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 25, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

February 13, 2020

Status Verified

February 1, 2020

Enrollment Period

5.5 years

First QC Date

August 12, 2016

Last Update Submit

February 11, 2020

Conditions

Infertility

Keywords

InfertilityTachykininKisspeptin

Outcome Measures

Primary Outcomes (9)

  • 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

    4 years

  • Expression level of neurokinin A (NKA)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot

    4 years

Secondary Outcomes (12)

  • Patient or donor age

    4 years

  • Patient or donor body mass index

    4 years

  • Years of infertility

    4 years

  • Estradiol level (day of ovulation induction)

    4 years

  • Progesterone level (day of ovulation induction)

    4 years

  • +7 more secondary outcomes

Study Arms (5)

Donors

ACTIVE COMPARATOR

Oocyte donors without infertility problems

Procedure: Ovarian puncture

PCOS

EXPERIMENTAL

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

Procedure: Ovarian puncture

Endometriosis

EXPERIMENTAL

Patients with endometriosis (I-IV)

Procedure: Ovarian puncture

Age

EXPERIMENTAL

Patients with advanced maternal age (38 years or more)

Procedure: Ovarian puncture

Low ovarian response

EXPERIMENTAL

Patients with low ovarian response according to Bologna criteria

Procedure: Ovarian puncture

Interventions

Ovarian puncturePROCEDURE

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.

AgeDonorsEndometriosisLow ovarian responsePCOS

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Instituto de Investigaciones QuĂ­micas

Seville, 41011, Spain

Location

IVI Sevilla

Seville, 41011, Spain

Location

Related Publications (2)

  • 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.

    PMID: 25316443BACKGROUND

  • 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.

    PMID: 27146034RESULT

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

August 12, 2016

First Posted

August 25, 2016

Study Start

January 1, 2014

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

February 13, 2020

Record last verified: 2020-02

Locations

ES(2)