Mitochondrial Energy Production in ART (Assisted Reproductive Technology )

NCT ID: NCT02727400

Last Updated: 2018-04-17

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-01

Study Completion Date

2018-04-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Female Infertility Due to Advanced Maternal Age

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

advanced maternal age

Infertile women due to advanced maternal age

No interventions assigned to this group

Young patients

women under 35 undergoing infertility treatments

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

46 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

IVI Madrid

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Juan A Garcia-Velasco, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

IVI Madrid

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

IVI Madrid

Madrid, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1512-MAD-064-JGPROTOCOLOf-151

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.