Female InfertilityNCT04019899
Myo-inositol and Vitamin D3 During IVF
A study testing study group in people with Female Infertility, run by Lo.Li.Pharma s.r.l at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Female Infertility
- What is being tested?
- study group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 2 May 2018to 31 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- BMI (kg/m2): 18.5 - 24.9
- basal FSH on day 3 <15 mIU/ml
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Female Infertility
- Being tested
- control group, study group
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control groupDietary supplement
- 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 groupDietary supplement
- 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 group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Not described Receives: Dietary Supplement: control group |
| Study group | Experimental | Not described Receives: Dietary Supplement: study group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implantation rate
number of gestational sacs observed at ecographic screening divided by the number of embryos transferred
Measured: Single time-point: at 6 weeks of pregnancy
oocyte and embryo quality
Classification of the morphological aspects under the optical microscope
Measured: Single time-point: respectively, 12 days and 15 days after the beginning of Controlled Ovarian Hyperstimulation
clinical pregnancy
Positive beta-hCG test after embryo transfer
Measured: Single time-point: at 14 days from embryo transfer
Secondary outcomes (3)
Gemellarity
Multiple gestational sacs observed at ecographic screening
Measured: Single time-point: at 6 weeks of pregnancy
Abortion rate
Loss of pregnancy
Measured: Single time-point: at 6 weeks of pregnancy
Number of FSH IU used for controlled ovarian hyperstimulation
Ovarian ultrasound investigation and serum estradiol level
Measured: Single time-point: about 10 days after the beginning of Controlled Ovarian Hyperstimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start2 May 2018
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lo.Li.Pharma s.r.l
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04019899
- Sponsor's protocol ID
- 000153
- Status last verified
- Jul 2019
- First submitted
- 10 Jul 2019
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Supplementation With Myo-inositol, Vitamin D3, Folic Acid and Melatonin on IVF Outcomes
- ClinicalTrials.gov ID
- NCT04019899
- Acronym / sponsor ID
- 000153
- Conditions
- Female Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Lo.Li.Pharma s.r.lIndustry (pharma, biotech, devices)
- Study start
- 2 May 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 15 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Dietary Supplement: control group |
| Study group | Experimental | Dietary Supplement: study group |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI (kg/m2): 18.5 - 24.9
- basal FSH on day 3 <15 mIU/ml
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Control group |
| 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. | Dietary supplement | Study group |
Primary outcome
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
3 secondary outcomes
Gemellarity
Time frame: Single time-point: at 6 weeks of pregnancy
Abortion rate
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing study group in people with Female Infertility, run by Lo.Li.Pharma s.r.l at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implantation rate (time frame: Single time-point: at 6 weeks of pregnancy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2019.