- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04019899
Myo-inositol and Vitamin D3 During IVF
July 12, 2019 updated by: Lo.Li.Pharma s.r.l
Effects of Supplementation With Myo-inositol, Vitamin D3, Folic Acid and Melatonin on IVF Outcomes
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
RM
-
Roma, RM, Italy, 00198
- Clinica Alma Res
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control group
|
|
Experimental: Study group
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Single time-point: at 6 weeks of pregnancy
|
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
|
Single time-point: respectively, 12 days and 15 days after the beginning of Controlled Ovarian Hyperstimulation
|
clinical pregnancy
Time Frame: Single time-point: at 14 days from embryo transfer
|
Positive beta-hCG test after embryo transfer
|
Single time-point: at 14 days from embryo transfer
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gemellarity
Time Frame: Single time-point: at 6 weeks of pregnancy
|
Multiple gestational sacs observed at ecographic screening
|
Single time-point: at 6 weeks of pregnancy
|
Abortion rate
Time Frame: Single time-point: at 6 weeks of pregnancy
|
Loss of pregnancy
|
Single time-point: at 6 weeks 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
|
Single time-point: about 10 days after the beginning of Controlled Ovarian Hyperstimulation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 2, 2018
Primary Completion (Actual)
May 31, 2019
Study Completion (Actual)
May 31, 2019
Study Registration Dates
First Submitted
July 10, 2019
First Submitted That Met QC Criteria
July 12, 2019
First Posted (Actual)
July 15, 2019
Study Record Updates
Last Update Posted (Actual)
July 15, 2019
Last Update Submitted That Met QC Criteria
July 12, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 000153
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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