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

ConditionFertility
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age32-38
SponsorProcare Health Iberia S.L.

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 volunteers

Qualifiers

- 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

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

300 Participants
are grouped into 1 trial group
Group A: Suplementation

Trial outcomes

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

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)

Secondary outcomes

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

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
From enrollment to visit 2 (9 months)

Other outcomes

Sponsors and contacts

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