An observational study in Fertility, sponsored by Procare Health Iberia S.L.. Active, not recruiting at 27 sites in Spain. Open to female participants aged 32 Years to 38 Years. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by Procare Health Iberia S.L. · Observational
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.
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.
Procare Health Iberia S.L. is the lead sponsor of 12 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
- 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:
Women on Ovosicare Fertility supplementation prescribed according to standard clinical practice
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.
Time frame: From enrollment to visit 2 (9 months)
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
Time frame: From enrollment to visit 2 (9 months)
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.
Time frame: From enrollment to visit 2 (9 months)
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.
Time frame: From enrollment to visit 2 (9 months)
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.
Time frame: From enrollment to visit 2 (9 months)
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.
Time frame: From enrollment to visit 2 (9 months)
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.
Time frame: From enrollment to visit 2 (9 months)
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.
Time frame: From enrollment to 6months (during sumplementation)
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.
Time frame: From enrollment to 6 months (during sumplementation)
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
Time frame: From enrollment to 6 months (during sumplementation)
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
Time frame: From enrollment to 6 months (during sumplementation)
Live birth rate
To evaluate the live birth rate
Time frame: After 9 moths after pregnancy confirmation
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Procare Health Iberia S.L.