Mitochondrial Energy Production in ART (Assisted Reproductive Technology ) (Mitenergy)

April 16, 2018 updated by: IVI Madrid

Impact on Mitochondrial Energy Production in Different Patient Populations in Women Undergoing IVF-ICSI (in Vitro Fertilization-intracytoplasmic Sperm Injection)

Oocyte maturation requires a lot of energy, which is provided by the mitochondria via the synthesis of ATP. The majority of patients with advanced maternal age (AMA) have poor egg quality. One of the reasons depends on oxidative phosphorylation of Pyruvate to undergo maturation; on the contrary, the cells of the cumulus (CC) show great activity glycolytic so that these cells are able to provide ATP(adenosine triphosphate and energy substrates to the oocyte. The goal of this work is to analyze the mitochondrial function and energy production in oocyte donors compared with a group of women of advanced maternal age subject to a same ovarian stimulation Protocol

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28035
        • IVI Madrid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 46 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Controls: Young women between 18-35 years old with good reproductive prognostic undergoing COS (controlled ovarian stimulation) for IVF-ICSI

Cases: Infertile Women > 38 years old undergoing COS (controlled ovarian stimulation) for IVF-ICSI

Description

Inclusion Criteria:

  • Controls: Women between 18-35 years old who are oocyte donors and fulfill the requirements of the our program of oocyte donation according to the Spanish Law of Human Reproduction
  • Cases: infertile women undergoing IVF due to advanced maternal age (>38 years)

Exclusion criteria:

For controls: Women with antral follicle count >20 or <6 follicle per ovary or with pathologies which, in the opinion of the investigator, may interfere with the treatment of ovarian stimulation

  • Severe hypersensitivity to drugs of similar structure
  • In the case of associated pathologies which can be considered as exclusion criteria on the part of the researcher are endocrine disruption and multi-follicular ovaries with risk of OHSS (Ovarian hyperstimulation syndrome)
  • Be positive in serology for syphilis, toxoplasmosis, rubella, gonorrhea, hepatitis B, hepatitis C and HIV and lack of personal history and family of hereditary diseases.

Cases

  • Irregular cycles
  • Previous Ovarian surgery
  • Previous chemotherapy or radiotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
advanced maternal age
Infertile women due to advanced maternal age
Young patients
women under 35 undergoing infertility treatments

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adenosine Triphosphate (ATP) production (nmol)
Time Frame: 15 days
ATP levels with the ATP assay kit (ab113849) Succinate dehydrogenase (SDH) activity assay kit (BioVision, USA) Mitochondrial Complex IV by colorimetric determination of oxidation-reduction processes of Cytochrome C
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IVI Madrid

Investigators

  • Principal Investigator: Juan A Garcia-Velasco, MD, PhD, IVI Madrid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2017

Primary Completion (Actual)

April 16, 2018

Study Completion (Actual)

April 16, 2018

Study Registration Dates

First Submitted

January 23, 2016

First Submitted That Met QC Criteria

March 29, 2016

First Posted (Estimate)

April 4, 2016

Study Record Updates

Last Update Posted (Actual)

April 17, 2018

Last Update Submitted That Met QC Criteria

April 16, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1512-MAD-064-JGPROTOCOLOf-151

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Female Infertility Due to Advanced Maternal Age

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe