About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
- 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.
Disqualifiers
- BMI > 30 kg/m2.
Azoospermia
Progressive motility <25%
Normal morphology ≤2%
Trial 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.
Trial design
Case-only
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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
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.
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.
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.
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