Clinical trial NCT02877992: Tachykinin and Kisspeptin Expression in Human Granulosa and Cumulus Cells
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: Infertility
Tachykinin
Kisspeptin
Lead sponsor: Vida Recoletas Sevilla
Sponsor class: OTHER
First posted: 2016-08-25
Enrollment: 236
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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)

Primary outcomes:
measure: Expression level of Substance P (SP)
timeFrame: 4 years
measure: Expression level of neurokinin A (NKA)
timeFrame: 4 years
measure: Expression level of neurokinin B (NKB)
timeFrame: 4 years
measure: Expression level of hemokinin 1 (HK-1)
timeFrame: 4 years
measure: Expression level of neurokinin 1 receptor (NK1R)
timeFrame: 4 years
measure: Expression of neurokinin 2 receptor (NK2R)
timeFrame: 4 years
measure: Expression level of neurokinin 3 receptor (NK3R)
timeFrame: 4 years
measure: Expression level of kisspeptin 1 (KISS1)
timeFrame: 4 years
measure: Expression level of kisspeptin 1 receptor (KISS1R)
timeFrame: 4 years
Secondary outcomes:
measure: Patient or donor age
timeFrame: 4 years
measure: Patient or donor body mass index
timeFrame: 4 years
measure: Years of infertility
timeFrame: 4 years
measure: Estradiol level (day of ovulation induction)
timeFrame: 4 years
measure: Progesterone level (day of ovulation induction)
timeFrame: 4 years
measure: Number of oocytes retrieved in the ovarian puncture
timeFrame: 4 years
measure: Number of mature oocytes (metaphase II) obtained in the ovarian puncture
timeFrame: 4 years
measure: Fertilization rate
timeFrame: 4 years
measure: Embryo quality
timeFrame: 4 years
measure: Daily and total dose of FSH (FSH = follicle stimulating hormone)
timeFrame: 4 years
measure: Daily and total dose of HMG (HMG = human menopausal gonadotropin)
timeFrame: 4 years
measure: Type of ovulation induction
timeFrame: 4 years
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Instituto de Investigaciones Químicas
city: Sevilla
country: Spain
facility: IVI Sevilla
Study officials:
References:
citation: Garcia-Ortega J, Pinto FM, Fernandez-Sanchez M, Prados N, Cejudo-Roman A, Almeida TA, Hernandez 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.
citation: Garcia-Ortega J, Pinto FM, Prados N, Bello AR, Almeida TA, Fernandez-Sanchez 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: 10.1095/biolreprod.116.139881. Epub 2016 May 4.