Prospective Observational Study to Evaluate Fertility in Women Between 32 and 38 Years Old Treated With the Ovosicare® Fertility Food Supplement Containing a Combination of MYO/DCI in a 3.6:1 Ratio, Antioxidants, Vitamins and Minerals
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 27
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 32 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •BMI > 30 kg/m
- •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%
- •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.
结局指标
主要结局
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
时间窗: From enrollment to visit 2 (9 months)
Women suspected of being pregnant will undergo a blood test to detect the hormone beta-hCG and a transvaginal ultrasound to confirm the pregnancy.
次要结局
- Evaluate the time until spontaneous clinical pregnancy(From enrollment to visit 2 (9 months))
- Evaluate changes in analytical parameters in blood: Biochemistry panel(From enrollment to visit 2 (9 months))
- Evaluate changes in analytical parameters in blood: Hormonal panel(From enrollment to visit 2 (9 months))
- Evaluate changes in karyotype(From enrollment to visit 2 (9 months))
- Evaluate the presence of anatomy changes by ultrasound test(From enrollment to visit 2 (9 months))
- To evaluate changes in the number of antral follicle by ultrasound test(From enrollment to visit 2 (9 months))
- Evaluate the safety profile of Ovosicare Fertility(From enrollment to 6months (during sumplementation))
- Ovosicare Fertility tolerability degree(From enrollment to 6 months (during sumplementation))
- Ovosicare Fertility use satisfaction degree(From enrollment to 6 months (during sumplementation))
- Ovosicare Fertility Adherence(From enrollment to 6 months (during sumplementation))
- Live birth rate(After 9 moths after pregnancy confirmation)