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出境医 / 临床实验 / Myo-inositol and Vitamin D3 During IVF

Myo-inositol and Vitamin D3 During IVF

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 Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
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.
Outcome Measures
Primary Outcome Measures :
  1. Implantation rate [ Time Frame: Single time-point: at 6 weeks of pregnancy ]
    number of gestational sacs observed at ecographic screening divided by the number of embryos transferred

  2. oocyte and embryo quality [ Time Frame: 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

  3. clinical pregnancy [ Time Frame: Single time-point: at 14 days from embryo transfer ]
    Positive beta-hCG test after embryo transfer


Secondary Outcome Measures :
  1. Gemellarity [ Time Frame: Single time-point: at 6 weeks of pregnancy ]
    Multiple gestational sacs observed at ecographic screening

  2. Abortion rate [ Time Frame: Single time-point: at 6 weeks of pregnancy ]
    Loss of pregnancy

  3. Number of FSH IU used for controlled ovarian hyperstimulation [ Time Frame: Single time-point: about 10 days after the beginning of Controlled Ovarian Hyperstimulation ]
    Ovarian ultrasound investigation and serum estradiol level


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
Layout table for location information
Italy
Clinica Alma Res
Roma, RM, Italy, 00198
Sponsors and Collaborators
Lo.Li.Pharma s.r.l
Tracking Information
First Submitted Date  ICMJE July 10, 2019
First Posted Date  ICMJE July 15, 2019
Last Update Posted Date July 15, 2019
Actual Study Start Date  ICMJE May 2, 2018
Actual Primary Completion Date May 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2019)
  • Implantation rate [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Single time-point: at 14 days from embryo transfer ]
    Positive beta-hCG test after embryo transfer
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2019)
  • Gemellarity [ Time Frame: Single time-point: at 6 weeks of pregnancy ]
    Multiple gestational sacs observed at ecographic screening
  • Abortion rate [ Time Frame: Single time-point: at 6 weeks of pregnancy ]
    Loss of pregnancy
  • Number of FSH IU used for controlled ovarian hyperstimulation [ Time Frame: Single time-point: about 10 days after the beginning of Controlled Ovarian Hyperstimulation ]
    Ovarian ultrasound investigation and serum estradiol level
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Myo-inositol and Vitamin D3 During IVF
Official Title  ICMJE Effects of Supplementation With Myo-inositol, Vitamin D3, Folic Acid and Melatonin on IVF Outcomes
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Female Infertility
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Active Comparator: Control group
    Intervention: Dietary Supplement: control group
  • Experimental: Study group
    Intervention: Dietary Supplement: study group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 12, 2019) 		120
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 31, 2019
Actual Primary Completion Date May 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 42 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04019899
Other Study ID Numbers  ICMJE 000153
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Lo.Li.Pharma s.r.l
Study Sponsor  ICMJE Lo.Li.Pharma s.r.l
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Lo.Li.Pharma s.r.l
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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