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

NCT ID: NCT07083999

Last Updated: 2025-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-13

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Fertility

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Suplementation

Women on Ovosicare Fertility supplementation prescribed according to standard clinical practice

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

32 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Procare Health Iberia S.L.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CM Sitges

Sitges, Barcelona, Spain

Site Status RECRUITING

HU de Getafe

Getafe, Madrid, Spain

Site Status RECRUITING

Clínica Rv Benalmádena

Benalmádena, Malaga, Spain

Site Status RECRUITING

H García Orcoyen

Estella-Lizarra, Navarre, Spain

Site Status RECRUITING

CP Dr. Andrade Andrade

A Coruña, , Spain

Site Status RECRUITING

CP Dra. Domenech Casanova

Alicante, , Spain

Site Status RECRUITING

H Vega Baja de Orihuela

Alicante, , Spain

Site Status RECRUITING

Clinica Alboran

Almería, , Spain

Site Status RECRUITING

CP Dr. Aragón Albillos

Almería, , Spain

Site Status RECRUITING

CM Teknon

Barcelona, , Spain

Site Status RECRUITING

CP Dra. Mallafre

Barcelona, , Spain

Site Status NOT_YET_RECRUITING

HU Vall d'Hebron

Barcelona, , Spain

Site Status RECRUITING

OBS Ginecólogos Burgos

Burgos, , Spain

Site Status RECRUITING

Clínica Attella

Castelló, , Spain

Site Status RECRUITING

HU de Donostia

Donostia / San Sebastian, , Spain

Site Status NOT_YET_RECRUITING

CP Dra. Skouri-Bnihech Tioua

Granada, , Spain

Site Status RECRUITING

CHU Insular - H Materno-Infantil

Las Palmas, , Spain

Site Status RECRUITING

Clínica Palacios

Madrid, , Spain

Site Status RECRUITING

Gymeiaka Dra. Oltra Badui

Madrid, , Spain

Site Status RECRUITING

Gymeiaka Dra. Pavón Sanz

Madrid, , Spain

Site Status RECRUITING

HU La Paz

Madrid, , Spain

Site Status RECRUITING

Clínica Imar

Murcia, , Spain

Site Status RECRUITING

Ancla Clínica Ginecológica

Pontevedra, , Spain

Site Status RECRUITING

HG de la Santísima Trinidad

Salamanca, , Spain

Site Status RECRUITING

CP Dra. Sánchez Quintana

Seville, , Spain

Site Status RECRUITING

HU i Politècnic la Fe

Valencia, , Spain

Site Status RECRUITING

Centro Ginecológico Bolonia

Zaragoza, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Josep Combalia

Role: CONTACT

0034 93 645 54 51

Other Identifiers

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FERTILOBS

Identifier Type: -

Identifier Source: org_study_id

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