Myo-inositol and Vitamin D3 During IVF

Sponsor

Lo.Li.Pharma s.r.l (Industry)

Overall Status

Completed

CT.gov ID

NCT04019899

Collaborator

(none)

120

Enrollment

Location

Arms

12.9

Actual Duration (Months)

9.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Female Infertility	Dietary Supplement: control group Dietary Supplement: study group	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 2, 2018

Actual Primary Completion Date :

May 31, 2019

Actual Study Completion Date :

May 31, 2019

Arms and Interventions

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.

Arm

Intervention/Treatment

Active Comparator: Control group

Dietary Supplement: control group

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 42 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinica Alma Res	Roma	RM	Italy	00198

Sponsors and Collaborators

Lo.Li.Pharma s.r.l

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lo.Li.Pharma s.r.l

ClinicalTrials.gov Identifier:

NCT04019899

Other Study ID Numbers:

000153

First Posted:

Jul 15, 2019

Last Update Posted:

Jul 15, 2019

Last Verified:

Jul 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infertility

Infertility, Female

Study Results

No Results Posted as of Jul 15, 2019