Myo-inositol and Vitamin D3 During IVF

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Supplementation With Myo-inositol, Vitamin D3, Folic Acid and Melatonin on IVF Outcomes

Conditions
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Female Infertility

Intervention / Treatment
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* Dietary Supplement: control group
* Dietary Supplement: study group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br> | Dietary Supplement: control group<br>* 2 g Myo-Inositol, 50 mg Alpha-Lactalbumin and 200 µg folic acid (1 sachet/day in the morning): from the first day of the menstrual cycle until 14 days after embryo transfer. If pregnancy occurs, until the 12th week of gestation. 600 mg Myo-Inositol, 200 µg folic acid, 1 mg melatonin (1 soft capsule/day in the evening): from the first day of the menstrual cycle until hCG administration. If pregnancy occurs, until the 12th week of gestation.<br>|
| Experimental: Study group<br> | Dietary Supplement: study group<br>* 2 g Myo-Inositol, 50 mg Alpha-Lactalbumin and 200 µg folic acid (1 sachet/day in the morning): from the first day of the menstrual cycle until 14 days after embryo transfer. If pregnancy occurs, until the 12th week of gestation. 600 mg Myo-Inositol, 200 µg folic acid, 1 mg melatonin (1 soft capsule/day in the evening): from the first day of the menstrual cycle until hCG administration; 600 mg Myo-Inositol, 200 µg folic acid, 1 mg melatonin, 50 µg vitamin D3 as cholecalciferol (1 soft capsule/day in the evening) substitutes the previous treatment at hCG administration and lasted until 14 days after embryo transfer. If pregnancy occurs, until the 12th week of gestation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation rate | number of gestational sacs observed at ecographic screening divided by the number of embryos transferred | Single time-point: at 6 weeks of pregnancy | 
| oocyte and embryo quality | Classification of the morphological aspects under the optical microscope | Single time-point: respectively, 12 days and 15 days after the beginning of Controlled Ovarian Hyperstimulation | 
| clinical pregnancy | Positive beta-hCG test after embryo transfer | Single time-point: at 14 days from embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gemellarity | Multiple gestational sacs observed at ecographic screening | Single time-point: at 6 weeks of pregnancy | 
| Abortion rate | Loss of pregnancy | Single time-point: at 6 weeks of pregnancy | 
| Number of FSH IU used for controlled ovarian hyperstimulation | Ovarian ultrasound investigation and serum estradiol level | Single time-point: about 10 days after the beginning of Controlled Ovarian Hyperstimulation |