Female Infertility Due to Advanced Maternal AgeMitenergyNCT02727400
Mitochondrial Energy Production in ART (Assisted Reproductive Technology )
An observational study of Female Infertility Due to Advanced Maternal Age, run by IVI Madrid at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 46 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female Infertility Due to Advanced Maternal Age
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2017to 16 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 46 years
- Women only
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| advanced maternal age | Infertile women due to advanced maternal age | |
| Young patients | women under 35 undergoing infertility treatments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenosine Triphosphate (ATP) production (nmol)
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
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2016 (estimated)
- Study start1 Apr 2017
- Primary completion16 Apr 2018
- Study completion16 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Infertility Due to Advanced Maternal AgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- IVI Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan A Garcia-Velasco, MD, PhD, Principal investigator, IVI Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02727400
- Sponsor's protocol ID
- 1512-MAD-064-JGPROTOCOLOf-151
- Acronym
- Mitenergy
- Status last verified
- Apr 2018
- First submitted
- 23 Jan 2016
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on Mitochondrial Energy Production in Different Patient Populations in Women Undergoing IVF-ICSI (in Vitro Fertilization-intracytoplasmic Sperm Injection)
- ClinicalTrials.gov ID
- NCT02727400
- Acronym / sponsor ID
- Mitenergy / 1512-MAD-064-JGPROTOCOLOf-151
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- IVI MadridUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 16 Apr 2018 (actual)
- Study completion
- 16 Apr 2018 (actual)
- First posted
- 4 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| advanced maternal age | – | –Infertile women due to advanced maternal age |
| Young patients | – | –women under 35 undergoing infertility treatments |
Who may qualify
- Ages
- 18 to 46 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan A Garcia-Velasco, MD, PhD principal investigator
IVI Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Female Infertility Due to Advanced Maternal Age, run by IVI Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenosine Triphosphate (ATP) production (nmol) (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.