Ovosicare® Fertility supplementation for women aged 32–38 trying to conceive
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
This study will try whether taking the Ovosicare® Fertility supplement helps women aged 32–38 who have been trying to get pregnant for at least six months become pregnant.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 32 Years to 38 Years |
| Sex | Female |
| Sponsor | Procare Health Iberia S.L. Industry-sponsored |
| Locations | 27 sites (Sitges, Barcelona and 26 other locations) |
| Trial ID | NCT07083999 on ClinicalTrials.gov |
What this trial studies
This observational study follows women aged 32–38 who begin taking the Ovosicare® Fertility food supplement after trying to conceive for at least six months. Participants are followed for up to 18 months with three routine clinic visits, and no extra tests beyond standard care are required. The study excludes women with BMI >30, partners with severe male-factor infertility, current pregnancy or breastfeeding, type 1 diabetes or thyroid disease, scheduled assisted reproduction, recent use of certain systemic medications, or known allergy to the supplement components. Pregnancies that occur during follow-up shorten the observation period and are recorded as study outcomes.
Who should consider this trial
Good fit: Women aged 32–38 who have been trying to conceive for at least six months, are not pregnant or breastfeeding, have BMI ≤30, have partners without severe male-factor infertility, and are not scheduled for assisted reproduction would be ideal candidates.
Not a fit: Women with severe male-factor infertility, BMI >30, active pregnancy or breastfeeding, type 1 diabetes or thyroid disease, scheduled assisted reproduction, recent use of excluded systemic medications, or known allergy to the product are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this could offer a simple, noninvasive supplement option to increase conception chances for women in this age group.
How similar studies have performed: Nutritional and supplement approaches to improve fertility have produced mixed results in prior studies, with limited high-quality evidence showing clear benefit.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Sitges, Barcelona and 26 other locations
- CM Sitges — Sitges, Barcelona, Spain (Recruiting)
- HU de Getafe — Getafe, Madrid, Spain (Recruiting)
- Clínica Rv Benalmádena — Benalmádena, Malaga, Spain (Recruiting)
- H García Orcoyen — Estella-Lizarra, Navarre, Spain (Recruiting)
- CP Dr. Andrade Andrade — A Coruña, Spain (Recruiting)
- CP Dra. Domenech Casanova — Alicante, Spain (Recruiting)
- H Vega Baja de Orihuela — Alicante, Spain (Recruiting)
- Clinica Alboran — Almería, Spain (Recruiting)
- CP Dr. Aragón Albillos — Almería, Spain (Recruiting)
- CM Teknon — Barcelona, Spain (Recruiting)
- CP Dra. Mallafre — Barcelona, Spain (Not_yet_recruiting)
- HU Vall d'Hebron — Barcelona, Spain (Recruiting)
- OBS Ginecólogos Burgos — Burgos, Spain (Recruiting)
- Clínica Attella — Castelló, Spain (Recruiting)
- HU de Donostia — Donostia / San Sebastian, Spain (Not_yet_recruiting)
- CP Dra. Skouri-Bnihech Tioua — Granada, Spain (Recruiting)
- CHU Insular - H Materno-Infantil — Las Palmas, Spain (Recruiting)
- Clínica Palacios — Madrid, Spain (Recruiting)
- Gymeiaka Dra. Oltra Badui — Madrid, Spain (Recruiting)
- Gymeiaka Dra. Pavón Sanz — Madrid, Spain (Recruiting)
- HU La Paz — Madrid, Spain (Recruiting)
- Clínica Imar — Murcia, Spain (Recruiting)
- Ancla Clínica Ginecológica — Pontevedra, Spain (Recruiting)
- HG de la Santísima Trinidad — Salamanca, Spain (Recruiting)
- CP Dra. Sánchez Quintana — Seville, Spain (Recruiting)
- HU i Politècnic la Fe — Valencia, Spain (Recruiting)
- Centro Ginecológico Bolonia — Zaragoza, Spain (Recruiting)
Study contacts
- Study coordinator: Josep Combalia
- Email: combalia.j@procarehealth.com
- Phone: 0034 93 645 54 51
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.