Female Infertility Due to Advanced Maternal Age Clinical Trial
— MitenergyOfficial title:
Impact on Mitochondrial Energy Production in Different Patient Populations in Women Undergoing IVF-ICSI (in Vitro Fertilization-intracytoplasmic Sperm Injection)
| Verified date | April 2018 |
| Source | IVI Madrid |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | April 16, 2018 |
| Est. primary completion date | April 16, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 46 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Spain | IVI Madrid | Madrid |
| Lead Sponsor | Collaborator |
|---|---|
| IVI Madrid |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 15 days |