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OpenTrials
Completed

NCT Number: NCT02727400

Mitochondrial Energy Production in ART (Assisted Reproductive Technology )

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

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Key information

Conditions

Female Infertility Due to Advanced Maternal Age

Age range

18 year–46 year

Sex eligibility

Female

Study type

Observational

Primary location

IVI Madrid

Madrid, 28035, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

IVI Madrid

Other

Registry information

Official study title

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

Acronym: Mitenergy

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 4, 2016
Registry last updated
Apr 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.