Myo-inositol and Vitamin D3 During IVF

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

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.

Study Overview

• Status: Completed
• Conditions: Female Infertility
• Intervention / Treatment: Dietary supplement: control group; Dietary supplement: study group

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • RM
    • Roma, RM, Italy, 00198
      • Clinica Alma Res

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group	Dietary supplement: control group; 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.
Experimental: Study group	Dietary supplement: study group; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Lo.Li.Pharma s.r.l

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2018
• Primary Completion (Actual): May 31, 2019
• Study Completion (Actual): May 31, 2019

Study Registration Dates

• First Submitted: July 10, 2019
• First Submitted That Met QC Criteria: July 12, 2019
• First Posted (Actual): July 15, 2019

Study Record Updates

• Last Update Posted (Actual): July 15, 2019
• Last Update Submitted That Met QC Criteria: July 12, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Infertility, Female
• Other Study ID Numbers: 000153

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No