Tachykinin and Kisspeptin Expression in Human Granulosa and Cumulus Cells

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Procedure: Ovarian puncture

• 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

Arm && Interventions

Group	Intervention	Description
Age	Ovarian puncture	Patients with advanced maternal age (38 years or more)
PCOS	Ovarian puncture	Patients with Polycystic Ovary Syndrome (PCOS) according to Rotterdam criteria
Low ovarian response	Ovarian puncture	Patients with low ovarian response according to Bologna criteria
Donors	Ovarian puncture	Oocyte donors without infertility problems
Endometriosis	Ovarian puncture	Patients with endometriosis (I-IV)

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
Patient or donor age	4 years	Years
Patient or donor body mass index	4 years	kg/m2
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)

Trial Locations

Locations (2)

Instituto de Investigaciones Químicas; 🇪🇸 Sevilla, Spain

IVI Sevilla; 🇪🇸 Sevilla, Spain