RecruitingNCT07083999

Observational Study to Evaluate Fertility in Women Between 32 and 38 Years Old Treated With the Ovosicare® Fertility

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


Sponsor

Procare Health Iberia S.L.

Enrollment

300 participants

Start Date

Feb 13, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 32 YearsMax Age: 38 Years

Inclusion Criteria3

  • \- 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 Criteria15

  • \- 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.

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Locations(27)

CM Sitges

Sitges, Barcelona, Spain

HU de Getafe

Getafe, Madrid, Spain

Clínica Rv Benalmádena

Benalmádena, Malaga, Spain

H García Orcoyen

Estella-Lizarra, Navarre, Spain

CP Dr. Andrade Andrade

A Coruña, Spain

CP Dra. Domenech Casanova

Alicante, Spain

H Vega Baja de Orihuela

Alicante, Spain

Clinica Alboran

Almería, Spain

CP Dr. Aragón Albillos

Almería, Spain

CM Teknon

Barcelona, Spain

CP Dra. Mallafre

Barcelona, Spain

HU Vall d'Hebron

Barcelona, Spain

OBS Ginecólogos Burgos

Burgos, Spain

Clínica Attella

Castelló, Spain

HU de Donostia

Donostia / San Sebastian, Spain

CP Dra. Skouri-Bnihech Tioua

Granada, Spain

CHU Insular - H Materno-Infantil

Las Palmas, Spain

Clínica Palacios

Madrid, Spain

Gymeiaka Dra. Oltra Badui

Madrid, Spain

Gymeiaka Dra. Pavón Sanz

Madrid, Spain

HU La Paz

Madrid, Spain

Clínica Imar

Murcia, Spain

Ancla Clínica Ginecológica

Pontevedra, Spain

HG de la Santísima Trinidad

Salamanca, Spain

CP Dra. Sánchez Quintana

Seville, Spain

HU i Politècnic la Fe

Valencia, Spain

Centro Ginecológico Bolonia

Zaragoza, Spain

View Full Details on ClinicalTrials.gov

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NCT07083999


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