Myo-inositol and Vitamin D3 During IVF

Female Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04019899
• Other study ID #: 000153
• Status: Completed
• Phase: N/A
• Start date: May 2, 2018
• Est. completion date: May 31, 2019

Study information

• Verified date: July 2019
• Source: Lo.Li.Pharma s.r.l
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Female Infertility
• Infertility
• Infertility, Female

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Clinica Alma Res	Roma	RM

Sponsors (1)

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

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	clinical pregnancy	Positive beta-hCG test after embryo transfer	Single time-point: at 14 days from embryo transfer
Secondary	Gemellarity	Multiple gestational sacs observed at ecographic screening	Single time-point: at 6 weeks of pregnancy
Secondary	Abortion rate	Loss of pregnancy	Single time-point: at 6 weeks of pregnancy
Secondary	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