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NCT Number: NCT07083999

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

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.

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Key information

Conditions

Fertility

Age range

32 year–38 year

Sex eligibility

Female

Study type

Observational

Primary location

CM Sitges, Sitges, Barcelona, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • - 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 criteria

  • - 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.

Treatment and study plan

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

    Time frame: From enrollment to visit 2 (9 months)

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

Secondary outcomes

  1. Evaluate the time until spontaneous clinical pregnancy

    Time frame: From enrollment to visit 2 (9 months)

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

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

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

    Time frame: From enrollment to visit 2 (9 months)

    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.

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

    Time frame: From enrollment to visit 2 (9 months)

    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.

  4. Evaluate changes in karyotype

    Time frame: From enrollment to visit 2 (9 months)

    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.

  5. Evaluate the presence of anatomy changes by ultrasound test

    Time frame: From enrollment to visit 2 (9 months)

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

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

    Time frame: From enrollment to visit 2 (9 months)

    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.

  7. Evaluate the safety profile of Ovosicare Fertility

    Time frame: From enrollment to 6months (during sumplementation)

    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.

  8. Ovosicare Fertility tolerability degree

    Time frame: From enrollment to 6 months (during sumplementation)

    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.

  9. Ovosicare Fertility use satisfaction degree

    Time frame: From enrollment to 6 months (during sumplementation)

    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

  10. Ovosicare Fertility Adherence

    Time frame: From enrollment to 6 months (during sumplementation)

    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

  11. Live birth rate

    Time frame: After 9 moths after pregnancy confirmation

    To evaluate the live birth rate

Study contacts

Contact information is provided by the study sponsor or research team.

Josep Combalia

CONTACT

[email protected]

0034 93 645 54 51

Sponsors and collaborators

Lead sponsor

Procare Health Iberia S.L.

Industry

Registry information

Official study 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

Acronym: FERTILOBS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 24, 2025
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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