Myo-inositol and Vitamin D3 During IVF

Lo.Li.Pharma

Status: Completed

Conditions: Female Infertility

Treatments: Dietary Supplement: control group; Dietary Supplement: study group

Study type: Interventional

Funder types: Industry

Identifiers

NCT04019899

000153

Details and patient eligibility

About

Administration of a multicomponent dietary supplement (myo-inositol, vitamin D3, folic acid and melatonin) to women undergoing IVF procedures.

The aim of the study is to monitor the effects on the pregnancy, implantation and abortion rates.

Enrollment: 120 patients

Sex: Female

Ages: 18 to 42 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BMI (kg/m2): 18.5 - 24.9
• basal FSH on day 3 <15 mIU/ml

Exclusion criteria

• presence of insulin resistance (IR)
• hyperglycaemia, hyperprolactinemia, hypothyroidism or androgen excess
• diagnosis of PCOS (according to Rotterdam ESHRE-ASRM Sponsored PCOS consensus workshop group)
• intake of hormones or drugs that can potentially influence the ovulation
• FSH>15 on day 3

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Control group

Active Comparator group

Treatment:

Dietary Supplement: control group

Study group

Experimental group

Treatment:

Dietary Supplement: study group