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FertilityFERTILOBSNCT07083999

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

An observational study of Fertility, run by Procare Health Iberia S.L. at 27 sites in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 32 to 38 years, women only
Conditions the study is for
Fertility
How many people
300 participants
Where
27 sitesSpain
Study dates
13 Feb 2025to Sep 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 32 to 38 years
  • Women only
  • No healthy volunteers
  • Adult

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.

Who may be able to join

  • - 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.

Who cannot join

  • - 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.
Show all 15Show fewer
  • - 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.

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

Spain27 sites

  • CP Dr. Andrade Andrade

    A Coruña

  • CP Dra. Domenech Casanova

    Alicante

  • H Vega Baja de Orihuela

    Alicante

  • Clinica Alboran

    Almería

  • CP Dr. Aragón Albillos

    Almería

  • CM Teknon

    Barcelona

  • CP Dra. Mallafre

    Barcelona

  • HU Vall d'Hebron

    Barcelona

  • Clínica Rv Benalmádena

    Benalmádena, Malaga

  • OBS Ginecólogos Burgos

    Burgos

  • Clínica Attella

    Castelló, 12004

  • HU de Donostia

    Donostia / San Sebastian, 20014

  • H García Orcoyen

    Estella-Lizarra, Navarre

  • HU de Getafe

    Getafe, Madrid

  • CP Dra. Skouri-Bnihech Tioua

    Granada

  • CHU Insular - H Materno-Infantil

    Las Palmas

  • Clínica Palacios

    Madrid

  • Gymeiaka Dra. Oltra Badui

    Madrid

  • Gymeiaka Dra. Pavón Sanz

    Madrid

  • HU La Paz

    Madrid

  • Clínica Imar

    Murcia

  • Ancla Clínica Ginecológica

    Pontevedra

  • HG de la Santísima Trinidad

    Salamanca

  • CP Dra. Sánchez Quintana

    Seville

  • CM Sitges

    Sitges, Barcelona

  • HU i Politècnic la Fe

    Valencia

  • Centro Ginecológico Bolonia

    Zaragoza

Other trials in Spain

About this study

Official title: 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

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.

Read the detailed description

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
Fertility
Keywords
FERTILOBS, Pregnancy, Food supplement, Ovosicare Fertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07083999
Study groupRoleWhat they receive
SuplementationWomen on Ovosicare Fertility supplementation prescribed according to standard clinical practice

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From enrollment to visit 2 (9 months)

Secondary outcomes (11)

  1. Evaluate the time until spontaneous clinical pregnancy

    The variable "time" (months) until pregnancy will be calculated using the following formula:

    Time (months)= (Date of pregnancy - Date of treatment intake) / 30.44

    Measured: From enrollment to visit 2 (9 months)

  2. Evaluate changes in analytical parameters in blood: Biochemistry panel

    Description: To evaluate physiological changes by measuring biochemistry levels in blood from patients who do not achieve spontaneous clinical pregnancy after 9 months from the start of supplementation.

    Measured: From enrollment to visit 2 (9 months)

  3. Evaluate changes in analytical parameters in blood: Hormonal panel

    To evaluate physiological changes by measuring hormonal levels in blood from patients who do not achieve spontaneous clinical pregnancy after 9 months from the start of supplementation.

    Measured: From enrollment to visit 2 (9 months)

  4. Evaluate changes in karyotype

    To evaluate changes in karyotype by measuring in blood from patients who do not achieve spontaneous clinical pregnancy after 9 months from the start of supplementation.

    Measured: From enrollment to visit 2 (9 months)

  5. Evaluate the presence of anatomy changes by ultrasound test

    To evaluate anatomic changes by ultrasound test in patients who do not achieve spontaneous clinical pregnancy after 9 months from the start of supplementation.

    Measured: From enrollment to visit 2 (9 months)

  6. To evaluate changes in the number of antral follicle by ultrasound test

    To evaluate changes in the number of antral follicle by ultrasound test in patients who do not achieve spontaneous clinical pregnancy after 9 months from the start of supplementation.

    Measured: From enrollment to visit 2 (9 months)

  7. Evaluate the safety profile of Ovosicare Fertility

    The percentage of patients with adverse events (AE) and serious adverse events (SAE) wil be described, as well as the total number of AEs and SAEs recorded up to visit 2. AEs will be coded using the MedDRA dictionary and their characteristics will be described as qualitative variables in terms of severity, intensity, causal relationship, and assessment of the response.

    Measured: From enrollment to 6months (during sumplementation)

  8. Ovosicare Fertility tolerability degree

    To evaluate the degree of tolerability of treatment with Ovosicare® Fertility by the investigator a qualitative variable will be collected considered as poor, bad, good, excellent.

    Measured: From enrollment to 6 months (during sumplementation)

  9. Ovosicare Fertility use satisfaction degree

    To evaluate the degree of investigator satisfaction with the use of Ovosicare® Fertility a qualitative variable will be collected considered as very insatisfied, insatisfied, satisfied, very satisfied

    Measured: From enrollment to 6 months (during sumplementation)

  10. Ovosicare Fertility Adherence

    Treatment adherence will be evaluated as a qualitative variable referring to the correct intake of treatment following the frequency prescribed by the investigator. The frequency is defined as: always, quite often, sometimes, never

    Measured: From enrollment to 6 months (during sumplementation)

  11. Live birth rate

    To evaluate the live birth rate

    Measured: After 9 moths after pregnancy confirmation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2025
  2. Study start13 Feb 2025
  3. Primary completionDec 2026 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07083999
Sponsor's protocol ID
FERTILOBS
Acronym
FERTILOBS
Status last verified
Oct 2026
First submitted
7 Feb 2025
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Fertility, run by Procare Health Iberia S.L. at 27 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: From enrollment to visit 2 (9 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07083999.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.

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