Infertility Clinical Trial
Official title:
The Effect of Ovamax on Oocyte Quality in Women Undergoing IVF
NCT number | NCT06203223 |
Other study ID # | UHR-17 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2021 |
Est. completion date | June 30, 2024 |
Oocyte quality is a basic parameter that affects embryo quality and therefore it influences the outcome of assisted reproduction. It has been suggested that oocyte quality is improved by the intake of vitamins and antioxidants. Ova-Max is a dietary supplement that consists of vitamins, minerals and antioxidants which improve women's oocytes by preventing oxidative stress. Specifically, Ovamax includes Chasteberry, Melatonin, Myo-Inositol, Folic Acid, Co-Enzyme Q10, Vitamin E, L-Arginine, Grape seed extract and Alpha-lipoic Acid. The purpose of this study is to evaluate the influence of Ova-max intake on oocyte quality in women undergoing In Vitro Fertilization. According to the research hypothesis the administration of Ova-Max for three months increases oocyte quality in women undergoing intracellular sperm injection after ovarian stimulation and oocyte retrieval.
Status | Recruiting |
Enrollment | 158 |
Est. completion date | June 30, 2024 |
Est. primary completion date | March 31, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 46 Years |
Eligibility | Inclusion Criteria: - Patients less than 46 years of age - ICSI for fertilisation to allow evaluation of oocyte quality Exclusion criteria: - Women with endometriosis - Women with only one ovary - More than two previous IVF cycles - Use of testicular sperm - Intake of other dietary supplements - Poor responders |
Country | Name | City | State |
---|---|---|---|
Greece | Papageorgiou Hospital | Thessaloníki | Central Macedonia |
Lead Sponsor | Collaborator |
---|---|
Aristotle University Of Thessaloniki | Eugonia IVF Unit, Athens, Greece |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean oocyte score | The sum of the total oocyte scores of the patient divided by the number of her oocytes.
Oocytes is assessed according to the following parameters: Oocyte shape Oocyte size Ooplasm characteristics Structure of the perivitelline space (PVS) Zona pellucida (ZP) and Polar body (PB) morphology Each parameter is graded as worst (-1), average (0), or best (1) and a total oocyte score (TOS) is calculated by summing up individual parameter assessments. The maximal TOS of an oocyte, therefore, could be +6, the lowest -6. |
1-3 hours after oocyte retrieval | |
Secondary | Percentage of mature oocytes | number of mature oocytes of a woman divided by her total oocyte number | 1-3 hours after oocyte retrieval | |
Secondary | Percentage of fertilised oocytes | number of oocytes of a woman that are fertilised divided by the total oocyte injected with sperm | 16-18 hours after fertilisation | |
Secondary | Blastulation rate | the number of embryos that have reached blastocyst stage divided by the number of fertilised oocytes | day 5 after fertilisation | |
Secondary | Pregnancy rate | the number of women who got pregnant divided by the number of women who underwent embryo transfer | 6 weeks after embryo transfer | |
Secondary | Total number of COCs collected | total number of cumulus oocyte complexes collected from each woman | immediately after oocyte retrieval |
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