Back to resultsMyo-inositol and Vitamin D3 During IVF
Primary Purpose
Female Infertility
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
control group
study group
Sponsored by
About this trial
This is an interventional treatment trial for Female Infertility
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
Sites / Locations
- Clinica Alma Res
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control group
Study group
Arm Description
Outcomes
Primary Outcome Measures
Implantation rate
number of gestational sacs observed at ecographic screening divided by the number of embryos transferred
oocyte and embryo quality
Classification of the morphological aspects under the optical microscope
clinical pregnancy
Positive beta-hCG test after embryo transfer
Secondary Outcome Measures
Gemellarity
Multiple gestational sacs observed at ecographic screening
Abortion rate
Loss of pregnancy
Number of FSH IU used for controlled ovarian hyperstimulation
Ovarian ultrasound investigation and serum estradiol level
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04019899
Brief Title
Myo-inositol and Vitamin D3 During IVF
Official Title
Effects of Supplementation With Myo-inositol, Vitamin D3, Folic Acid and Melatonin on IVF Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
May 2, 2018 (Actual)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
May 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lo.Li.Pharma s.r.l
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Title
Study group
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
control group
Intervention 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
study group
Intervention 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.
Primary Outcome Measure Information:
Title
Implantation rate
Description
number of gestational sacs observed at ecographic screening divided by the number of embryos transferred
Time Frame
Single time-point: at 6 weeks of pregnancy
Title
oocyte and embryo quality
Description
Classification of the morphological aspects under the optical microscope
Time Frame
Single time-point: respectively, 12 days and 15 days after the beginning of Controlled Ovarian Hyperstimulation
Title
clinical pregnancy
Description
Positive beta-hCG test after embryo transfer
Time Frame
Single time-point: at 14 days from embryo transfer
Secondary Outcome Measure Information:
Title
Gemellarity
Description
Multiple gestational sacs observed at ecographic screening
Time Frame
Single time-point: at 6 weeks of pregnancy
Title
Abortion rate
Description
Loss of pregnancy
Time Frame
Single time-point: at 6 weeks of pregnancy
Title
Number of FSH IU used for controlled ovarian hyperstimulation
Description
Ovarian ultrasound investigation and serum estradiol level
Time Frame
Single time-point: about 10 days after the beginning of Controlled Ovarian Hyperstimulation
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Clinica Alma Res
City
Roma
State/Province
RM
ZIP/Postal Code
00198
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
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Myo-inositol and Vitamin D3 During IVF
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