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

NCT07083999 | Recruiting

• 1 other identifier: FERTILOBS
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 27

Brief 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.

Conditions

Fertility

Keywords

FERTILOBS; Pregnancy; Food supplement; Ovosicare Fertility

Outcome Measures

Primary Outcomes (1)

• 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

  Women suspected of being pregnant will undergo a blood test to detect the hormone beta-hCG and a transvaginal ultrasound to confirm the pregnancy.

  From enrollment to visit 2 (9 months)

Secondary Outcomes (11)

• Evaluate the time until spontaneous clinical pregnancy

  From enrollment to visit 2 (9 months)

• Evaluate changes in analytical parameters in blood: Biochemistry panel

  From enrollment to visit 2 (9 months)

• Evaluate changes in analytical parameters in blood: Hormonal panel

  From enrollment to visit 2 (9 months)

• Evaluate changes in karyotype

  From enrollment to visit 2 (9 months)

• Evaluate the presence of anatomy changes by ultrasound test

  From enrollment to visit 2 (9 months)

Study Arms (1)

Suplementation

Women on Ovosicare Fertility supplementation prescribed according to standard clinical practice

Eligibility Criteria

• Age: 32 Years - 38 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be approximately 300 women between 32 and 38 years of age who go to the doctor indicating that they are having difficulty getting pregnant (at least 6 months without getting pregnant), to whom a dietary supplement based on Myo-inositol and D-Chiro-inositol in combination (Ovosicare® Fertility) will be prescribed as per standard clinical practice.

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Procare Health Iberia S.L.: lead

Study Sites (27)

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, 12004, Spain

RECRUITING

HU de Donostia

Donostia / San Sebastian, 20014, 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

Central Study Contacts

Josep Combalia

CONTACT

0034 93 645 54 51; combalia.j@procarehealth.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: July 24, 2025
• Study Start: February 13, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-07

Locations

ES (27)