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Tachykinin and Kisspeptin Expression in Human Granulosa and Cumulus Cells

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02877992
Enrollment
236
Registered
2016-08-25
Start date
2014-01-31
Completion date
2019-07-31
Last updated
2020-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

Infertility, Tachykinin, Kisspeptin

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.

Interventions

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.

Sponsors

Vida Recoletas Sevilla
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

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)

Design outcomes

Primary

MeasureTime frameDescription
Expression level of Substance P (SP)4 yearsExpression 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 A (NKA)4 yearsExpression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot
Expression level of neurokinin B (NKB)4 yearsExpression 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 yearsExpression 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 yearsExpression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot
Expression of neurokinin 2 receptor (NK2R)4 yearsExpression 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 yearsExpression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot
Expression level of kisspeptin 1 (KISS1)4 yearsExpression 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 yearsExpression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot

Secondary

MeasureTime frameDescription
Years of infertility4 yearsNumber of years that the patient has been trying to have a child without success
Daily and total dose of FSH (FSH = follicle stimulating hormone)4 yearsDaily dose of FSH for controlled ovarian stimulation. International Units (IU)
Progesterone level (day of ovulation induction)4 yearsProgesterone level in blood (ng/mL), measured the day in which ovulation is induced
Estradiol level (day of ovulation induction)4 yearsEstradiol level in blood (pg/mL), measured the day in which ovulation is induced
Daily and total dose of HMG (HMG = human menopausal gonadotropin)4 yearsDaily dose of HMG for controlled ovarian stimulation. International Units (IU)
Type of ovulation induction4 yearsOvulation induction using 6500 IU of hCG (hCG = human chorionic gonadotropin) or 0.2 mg of triptorelin (Decapeptyl)
Number of oocytes retrieved in the ovarian puncture4 years
Number of mature oocytes (metaphase II) obtained in the ovarian puncture4 years
Fertilization rate4 yearsProportion of oocytes correctly fertilized (2 pronuclei and 2 polar bodies) after the ICSI (ICSI = intracytoplasmic sperm injection) procedure
Embryo quality4 yearsEmbryo 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.
Patient or donor age4 yearsYears
Patient or donor body mass index4 yearskg/m2

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026