FERTILOBSOvosicare® Fertility Supplement in Women Aged 32-38
Data Collection
Collected from today forward - ProspectiveCase-Only
Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.Summary
Study start date: February 13, 2025
Actual date on which the first participant was enrolled.This study aims to understand how a fertility supplement called Ovosicare® affects women aged 32 to 38 who are trying to become pregnant. Ovosicare® contains a mix of ingredients, including MYO/DCI in a specific ratio, plus antioxidants, vitamins, and minerals. The research focuses on whether taking this supplement can increase the chances of getting pregnant naturally within six months. This is important because it could provide a non-invasive option for women in this age range who are looking to boost their fertility and increase their chances of conception. Participants in the study will take Ovosicare® for up to 18 months, but the period may be shorter if they become pregnant. Over the course of the study, they will have three visits, but these will not require any extra tests beyond standard clinical practice. To check if the supplement is effective, women suspected of being pregnant will have a blood test to measure the hormone beta-hCG and an ultrasound to confirm the pregnancy. This process aims to ensure that any pregnancies occurring are documented and analyzed to assess the supplement's potential benefits.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.300 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-only
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 32 to 38 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion Criteria: 1. \- Women who agree to participate in the study by signing the informed consent. 2. \- Between 32 and 38 years old. 3. \- Who come to doctor´s office stating that they have been trying to get pregnant for at least 6 months. Exclusion Criteria: 1. \- BMI \> 30 kg/m2. 2. \- 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% 3. \- Pregnant or breastfeeding women. 4. \- Patients with type 1 diabetes or thyroid disease. 5. \- Patients with any assisted reproduction technique scheduled during the duration of the study. 6. \- Patients who have used or taken systemic steroids, anticonvulsants, antiretroviral treatment for HIV or hepatitis B in the last month. 7. \- Patients with a known allergy to any of the components of Ovosicare® Fertility. 8. \- Any other situation that, in the medical opinion, advises against treatment with Ovosicare® Fertility or that may make patient follow-up difficult. 9. \- Patients with suspected endometriosis. 10. \- Existence of fibroids affecting the endometrial cavity. 11. \- Patients with 2 or more previous abortions. 12. \- Patients with a current diagnosis of a high-risk human papillomavirus (HPV) cervical lesion.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 27 locations
CP Dra. Skouri-Bnihech Tioua
Granada, SpainCHU Insular - H Materno-Infantil
Las Palmas, SpainClínica Palacios
Madrid, Spain