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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suplementation | Women on Ovosicare Fertility supplementation prescribed according to standard clinical practice |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to visit 2 (9 months) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From enrollment to visit 2 (9 months) |
| Evaluate changes in analytical parameters in blood: Biochemistry panel |
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Inclusion Criteria:
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:
- 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.
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Josep Combalia | Contact | 0034 93 645 54 51 | combalia.j@procarehealth.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CM Sitges | Recruiting | Sitges | Barcelona | Spain | ||
| HU de Getafe |
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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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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 | From enrollment to 6 months (during sumplementation) |
| Live birth rate | To evaluate the live birth rate | After 9 moths after pregnancy confirmation |
| Recruiting |
| Getafe |
| Madrid |
| Spain |
| Clínica Rv Benalmádena | Recruiting | Benalmádena | Malaga | Spain |
| H García Orcoyen | Recruiting | Estella-Lizarra | Navarre | Spain |
| CP Dr. Andrade Andrade | Recruiting | A Coruña | Spain |
| CP Dra. Domenech Casanova | Recruiting | Alicante | Spain |
| H Vega Baja de Orihuela | Recruiting | Alicante | Spain |
| Clinica Alboran | Recruiting | Almería | Spain |
| CP Dr. Aragón Albillos | Recruiting | Almería | Spain |
| CM Teknon | Recruiting | Barcelona | Spain |
| CP Dra. Mallafre | Not yet recruiting | Barcelona | Spain |
| HU Vall d'Hebron | Recruiting | Barcelona | Spain |
| OBS Ginecólogos Burgos | Recruiting | Burgos | Spain |
| Clínica Attella | Recruiting | Castelló | 12004 | Spain |
| HU de Donostia | Not yet recruiting | Donostia / San Sebastian | 20014 | Spain |
| CP Dra. Skouri-Bnihech Tioua | Recruiting | Granada | Spain |
| CHU Insular - H Materno-Infantil | Recruiting | Las Palmas | Spain |
| Clínica Palacios | Recruiting | Madrid | Spain |
| Gymeiaka Dra. Oltra Badui | Recruiting | Madrid | Spain |
| Gymeiaka Dra. Pavón Sanz | Recruiting | Madrid | Spain |
| HU La Paz | Recruiting | Madrid | Spain |
| Clínica Imar | Recruiting | Murcia | Spain |
| Ancla Clínica Ginecológica | Recruiting | Pontevedra | Spain |
| HG de la Santísima Trinidad | Recruiting | Salamanca | Spain |
| CP Dra. Sánchez Quintana | Recruiting | Seville | Spain |
| HU i Politècnic la Fe | Recruiting | Valencia | Spain |
| Centro Ginecológico Bolonia | Recruiting | Zaragoza | Spain |