Myo-inositol and Vitamin D3 During IVF

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

Sponsors

Lead Sponsor: Lo.Li.Pharma s.r.l

Source Lo.Li.Pharma s.r.l
Brief Summary

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.

Overall Status Completed
Start Date May 2, 2018
Completion Date May 31, 2019
Primary Completion Date May 31, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Implantation rate Single time-point: at 6 weeks of pregnancy
oocyte and embryo quality Single time-point: respectively, 12 days and 15 days after the beginning of Controlled Ovarian Hyperstimulation
clinical pregnancy Single time-point: at 14 days from embryo transfer
Secondary Outcome
Measure Time Frame
Gemellarity Single time-point: at 6 weeks of pregnancy
Abortion rate Single time-point: at 6 weeks of pregnancy
Number of FSH IU used for controlled ovarian hyperstimulation Single time-point: about 10 days after the beginning of Controlled Ovarian Hyperstimulation
Enrollment 120
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: control group

Description: 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.

Arm Group Label: Control group

Intervention Type: Dietary Supplement

Intervention Name: study group

Description: 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.

Arm Group Label: Study group

Eligibility

Criteria:

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

Gender: Female

Minimum Age: 18 Years

Maximum Age: 42 Years

Healthy Volunteers: No

Location
Facility: Clinica Alma Res
Location Countries

Italy

Verification Date

July 2019

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Control group

Type: Active Comparator

Label: Study group

Type: Experimental

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov