Mitochondrial Energy Production in ART (Assisted Reproductive Technology )

Completed

• Conditions: Female Infertility Due to Advanced Maternal Age

• Registration Number: NCT02727400
• Lead Sponsor: IVI Madrid

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-23
• Study First Submitted QC: 2016-03-29
• Study First Posted: 2016-04-04
• Study Start: 2017-04-01
• Status Verified: 2018-04
• Primary Completion: 2018-04-16
• Study Completion: 2018-04-16
• Last Update Submitted: 2018-04-16
• Last Update Posted: 2018-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adenosine Triphosphate (ATP) production (nmol)	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

Trial Locations

Locations (1)

IVI Madrid; 🇪🇸 Madrid, Spain