Observational Study to Evaluate Fertility in Women Between 32 and 38 Years Old Treated With the Ovosicare® Fertility
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Fertility. Basic parameters: 32 years — 38 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Observational Study to Evaluate Fertility in Women Between 32 and 38 Years Old Treated With the Ovosicare® Fertility Food Supplement Containing a Combination of MYO/DCI in a 3.6:1 Ratio, Antioxidants, Vitamins and Minerals
Overview
The goal of this observational study is to evaluate whether supplementation with the Ovosicare® Fertility food supplement increases the possibility of becoming pregnant in women aged between 32 and 38 years who have been trying to become pregnant for at least 6 months before starting supplementation.
Detailed description
The duration of participation in the study for each patient will be a maximum of 18 months. This follow-up period may be shorter if a pregnancy occurs.
The number of visits throughout the study will be a total of three. Please note that you will not have to undergo additional tests or attend any extraordinary visits due to participating in this study, since the procedures you will undergo are the same as those routinely carried out in clinical practice.
Primary outcome measures
- Evaluate the rate of spontaneous pregnancy in women between 32 and 38 years old after a maximum of 6 months of supplementation with Ovosicare Fertility [Time frame: From enrollment to visit 2 (9 months)]
Secondary outcome measures (11)
- Evaluate the time until spontaneous clinical pregnancy [Time frame: From enrollment to visit 2 (9 months)]
- Evaluate changes in analytical parameters in blood: Biochemistry panel [Time frame: From enrollment to visit 2 (9 months)]
- Evaluate changes in analytical parameters in blood: Hormonal panel [Time frame: From enrollment to visit 2 (9 months)]
- Evaluate changes in karyotype [Time frame: From enrollment to visit 2 (9 months)]
- Evaluate the presence of anatomy changes by ultrasound test [Time frame: From enrollment to visit 2 (9 months)]
- To evaluate changes in the number of antral follicle by ultrasound test [Time frame: From enrollment to visit 2 (9 months)]
- Evaluate the safety profile of Ovosicare Fertility [Time frame: From enrollment to 6months (during sumplementation)]
- Ovosicare Fertility tolerability degree [Time frame: From enrollment to 6 months (during sumplementation)]
- Ovosicare Fertility use satisfaction degree [Time frame: From enrollment to 6 months (during sumplementation)]
- Ovosicare Fertility Adherence [Time frame: From enrollment to 6 months (during sumplementation)]
- Live birth rate [Time frame: After 9 moths after pregnancy confirmation]
Eligibility criteria
Inclusion criteria
- \- Women who agree to participate in the study by signing the informed consent.
- \- Between 32 and 38 years old.
- \- Who come to doctor´s office stating that they have been trying to get pregnant for at least 6 months.
Exclusion criteria
- \- BMI > 30 kg/m2.
- \- Existence of severe male factor subfertility according to the criteria of the World Health Organization (WHO), with at least one analysis obtained in the last 6 months with one or more variables with values of:
- Azoospermia
- Progressive motility <25%
- Normal morphology ≤2%
- \- Pregnant or breastfeeding women.
- \- Patients with type 1 diabetes or thyroid disease.
- \- Patients with any assisted reproduction technique scheduled during the duration of the study.
- \- Patients who have used or taken systemic steroids, anticonvulsants, antiretroviral treatment for HIV or hepatitis B in the last month.
- \- Patients with a known allergy to any of the components of Ovosicare® Fertility.
- \- Any other situation that, in the medical opinion, advises against treatment with Ovosicare® Fertility or that may make patient follow-up difficult.
- \- Patients with suspected endometriosis.
- \- Existence of fibroids affecting the endometrial cavity.
- \- Patients with 2 or more previous abortions.
- \- Patients with a current diagnosis of a high-risk human papillomavirus (HPV) cervical lesion.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Spain · 27 centers
- CM Sitges — Sitges
- HU de Getafe — Getafe
- Clínica Rv Benalmádena — Benalmádena
- H García Orcoyen — Estella-Lizarra
- CP Dr. Andrade Andrade — A Coruña
- CP Dra. Domenech Casanova — Alicante
- H Vega Baja de Orihuela — Alicante
- Clinica Alboran — Almería
- … and 19 more centers
Identifiers
NCT: NCT07083999 · FERTILOBS