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

Procare Health

Status: Enrolling

Conditions: Fertility

Study type: Observational

Funder types: Industry

Identifiers

NCT07083999

FERTILOBS

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 32 to 38 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. • Women who agree to participate in the study by signing the informed consent.
2. • Between 32 and 38 years old.
3. • Who come to doctor´s office stating that they have been trying to get pregnant for at least 6 months.

Exclusion criteria

1. • BMI > 30 kg/m2.

2. • 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%
3. • Pregnant or breastfeeding women.
4. • Patients with type 1 diabetes or thyroid disease.
5. • Patients with any assisted reproduction technique scheduled during the duration of the study.
6. • Patients who have used or taken systemic steroids, anticonvulsants, antiretroviral treatment for HIV or hepatitis B in the last month.
7. • Patients with a known allergy to any of the components of Ovosicare® Fertility.
8. • Any other situation that, in the medical opinion, advises against treatment with Ovosicare® Fertility or that may make patient follow-up difficult.
9. • Patients with suspected endometriosis.
10. • Existence of fibroids affecting the endometrial cavity.
11. • Patients with 2 or more previous abortions.
12. • Patients with a current diagnosis of a high-risk human papillomavirus (HPV) cervical lesion.

Trial design

300 participants in 1 patient group

Suplementation

Description:

Women on Ovosicare Fertility supplementation prescribed according to standard clinical practice