Tachykinin and Kisspeptin Expression in Human Granulosa and Cumulus Cells

Not Applicable

Completed

• Conditions: Infertility

• Registration Number: NCT02877992
• Lead Sponsor: IVI Sevilla

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2016-08-12
• Study First Submitted QC: 2016-08-19
• Study First Posted: 2016-08-25
• Primary Completion: 2019-07
• Study Completion: 2019-07
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-11
• Last Update Posted: 2020-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 236

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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
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
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
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
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
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
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
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
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

Secondary Outcome Measures

Name	Time	Method
Years of infertility	4 years	Number of years that the patient has been trying to have a child without success
Fertilization rate	4 years	Proportion of oocytes correctly fertilized (2 pronuclei and 2 polar bodies) after the ICSI (ICSI = intracytoplasmic sperm injection) procedure
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.
Daily and total dose of FSH (FSH = follicle stimulating hormone)	4 years	Daily dose of FSH for controlled ovarian stimulation. International Units (IU)
Estradiol level (day of ovulation induction)	4 years	Estradiol level in blood (pg/mL), measured the day in which ovulation is induced
Progesterone level (day of ovulation induction)	4 years	Progesterone level in blood (ng/mL), measured the day in which ovulation is induced
Number of oocytes retrieved in the ovarian puncture	4 years
Daily and total dose of HMG (HMG = human menopausal gonadotropin)	4 years	Daily dose of HMG for controlled ovarian stimulation. International Units (IU)
Number of mature oocytes (metaphase II) obtained in the ovarian puncture	4 years
Type of ovulation induction	4 years	Ovulation induction using 6500 IU of hCG (hCG = human chorionic gonadotropin) or 0.2 mg of triptorelin (Decapeptyl)
Patient or donor age	4 years	Years
Patient or donor body mass index	4 years	kg/m2

Trial Locations

Locations (2)

Instituto de Investigaciones Químicas; 🇪🇸 Sevilla, Spain

IVI Sevilla; 🇪🇸 Sevilla, Spain