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Clinical Trials/NCT02877992
NCT02877992
Completed
Not Applicable

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

IVI Sevilla2 sites in 1 country236 target enrollmentJanuary 2014
ConditionsInfertility

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infertility
Sponsor
IVI Sevilla
Enrollment
236
Locations
2
Primary Endpoint
Expression level of neurokinin A (NKA)
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
July 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
IVI Sevilla
Responsible Party
Principal Investigator
Principal Investigator

Manuel Fernandez-Sanchez

Dr

IVI Sevilla

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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

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

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

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

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

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

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

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

Secondary Outcomes

  • Years of infertility(4 years)
  • Fertilization rate(4 years)
  • Embryo quality(4 years)
  • Daily and total dose of FSH (FSH = follicle stimulating hormone)(4 years)
  • Patient or donor age(4 years)
  • Estradiol level (day of ovulation induction)(4 years)
  • Patient or donor body mass index(4 years)
  • Progesterone level (day of ovulation induction)(4 years)
  • Number of oocytes retrieved in the ovarian puncture(4 years)
  • Daily and total dose of HMG (HMG = human menopausal gonadotropin)(4 years)
  • Number of mature oocytes (metaphase II) obtained in the ovarian puncture(4 years)
  • Type of ovulation induction(4 years)

Study Sites (2)

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