Tachykinin and Kisspeptin Expression in Human Granulosa and Cumulus Cells

NCT ID: NCT02877992

Last Updated: 2020-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

236 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2019-07-31

Brief Summary

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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

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Conditions

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Infertility

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Donors

Oocyte donors without infertility problems

Group Type ACTIVE_COMPARATOR

Ovarian puncture

Intervention Type PROCEDURE

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.

PCOS

Patients with Polycystic Ovary Syndrome (PCOS) according to Rotterdam criteria

Group Type EXPERIMENTAL

Ovarian puncture

Intervention Type PROCEDURE

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.

Endometriosis

Patients with endometriosis (I-IV)

Group Type EXPERIMENTAL

Ovarian puncture

Intervention Type PROCEDURE

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.

Age

Patients with advanced maternal age (38 years or more)

Group Type EXPERIMENTAL

Ovarian puncture

Intervention Type PROCEDURE

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.

Low ovarian response

Patients with low ovarian response according to Bologna criteria

Group Type EXPERIMENTAL

Ovarian puncture

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age between 18 and 34 years
* Normal caryotype
* Normal psychological test


* 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)

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Vida Recoletas Sevilla

OTHER

Sponsor Role lead

Responsible Party

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Manuel Fernandez-Sanchez

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Instituto de Investigaciones QuĂ­micas

Seville, , Spain

Site Status

IVI Sevilla

Seville, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 25316443 (View on PubMed)

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.

Reference Type RESULT
PMID: 27146034 (View on PubMed)

Other Identifiers

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IVISEVILLA

Identifier Type: -

Identifier Source: org_study_id

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