Tachykinin and Kisspeptin Expression in Human Granulosa and Cumulus Cells

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02877992
• Other study ID #: IVISEVILLA
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: July 2019

Study information

• Verified date: February 2020
• Source: IVI Sevilla
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Infertility

Intervention

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.

Locations

Country	Name	City	State
Spain	Instituto de Investigaciones Químicas	Sevilla
Spain	IVI Sevilla	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
IVI Sevilla

Country where clinical trial is conducted

Spain, 

References & Publications (2)

García-Ortega J, Pinto FM, Fernández-Sánchez M, Prados N, Cejudo-Román A, Almeida TA, Hernández 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. — View Citation

García-Ortega J, Pinto FM, Prados N, Bello AR, Almeida TA, Fernández-Sánchez 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: 10.1 — View Citation

Outcome

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