Women InfertilityNCT03055442
Myo-inositol/D-chiro-inositol Ratio in Follicular Fluid
An observational study of Women Infertility, run by Lo.Li.Pharma s.r.l at 1 site in Greece.
Trial summary
Considering the importance assumed by follicular microenvironment for a proper oocyte development, this study is a prospective observational clinical trial which aims to evaluate whether the embryo blastocyst quality may be affected by different Myo-inositol (MI) and D-chiro-inositol (DCI) levels in the follicular… Read more about this study
- Who is it for?
- Ages 18 to 28 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Women Infertility
- What is being tested?
- Dosage of myo-inositol and Dosage of D-chiro-inositol
- How many people
- 34 participants
- Where
- 1 siteGreece
- Study dates
- Oct 2016to Dec 2016
- Phase
- Observational
- 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 28 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The study included 8 egg donors participating in the donation program of IAKENTRO not for the first time, and 11 recipient couples undergoing in vitro fertilization (ICSI). Follicular fluid (FF) specimens were analysed.
Who may be able to join
- clear follicular aspirate obtained during oocyte retrieval;
- each specimen of follicular fluid containing only one oocyte.
Who cannot join
- hyperglycaemic women;
- PCOS women also if euglycaemic;
- diabetic subjects having low concentrations of detectable MI in association with an anomalous MI transport.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Altered Myo-inositol/D-chiro-inositol Ratio in Follicular Fluid of Women Undergoing in Vitro Fertilization Has Detrimental Effects on Oocyte and Embryo Quality
Considering the importance assumed by follicular microenvironment for a proper oocyte development, this study is a prospective observational clinical trial which aims to evaluate whether the embryo blastocyst quality may be affected by different Myo-inositol (MI) and D-chiro-inositol (DCI) levels in the follicular fluid (FF) of the aspired oocytes. The study includes egg donors and egg receiving couples participating in the oocyte donation program. MI/DCI is calculated in FF and related with blastocyst grade.
- Conditions
- Women Infertility
- Being tested
- Dosage of myo-inositol, Dosage of D-chiro-inositol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dosage of myo-inositolOther
Quantitative analysis of myo-inositol was performed by gas chromatography-mass spectrometry (GC-MS)
Dosage of D-chiro-inositolOther
Quantitative analysis of D-chiro-inositol was performed by gas chromatography-mass spectrometry (GC-MS)
| Study group | Role | What they receive |
|---|---|---|
| Follicular Fluids | Follicular fluids obtained by 8 oocyte donors Receives: Other: Dosage of myo-inositol; Other: Dosage of D-chiro-inositol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myo-inositol concentration (µmol/l) in follicular fluid
After transvaginal aspiration of oocyte and follicular fluid and subsequent ICSI, at the day 5 the cultured embryos were graded according to Gardner's grading system for blastocysts. Then follicular fluids specimens were divided following the different scores given to the respective blastocysts, and their content in myo-inositol was quantified.
In each sample of follicular fluid myo-inositol levels were assessed. The quantitative analysis was performed by means of gas chromatography-mass spectrometry (GC-MS) and the values were expressed as µmol/l. This value was related to the respective blastocyst grade.
Measured: 5th day from pick up
D-chiro-inositol concentration (µmol/l) in follicular fluid
After transvaginal aspiration of oocyte and follicular fluid and subsequent ICSI, at the day 5 the cultured embryos were graded according to Gardner's grading system for blastocysts. Then follicular fluids specimens were divided following the different scores given to the respective blastocysts, and their content in D-chiro-inositol was quantified.
In each sample of follicular fluid D-chiro-inositol levels were assessed. The quantitative analysis was performed by means of gas chromatography-mass spectrometry (GC-MS) and the values were expressed as µmol/l. This value was related to the respective blastocyst grade.
Measured: 5th day from pick up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study startOct 2016
- Primary completionNov 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Women 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 34 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
- NCT03055442
- Sponsor's protocol ID
- MI/DCI_FF
- Status last verified
- Feb 2017
- First submitted
- 8 Feb 2017
- Last updated
- 16 Feb 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chiu TT, Rogers MS, Law EL, Briton-Jones CM, Cheung LP, Haines CJ. Follicular fluid and serum concentrations of myo-inositol in patients undergoing IVF: relationship with oocyte quality. Hum Reprod. 2002 Jun;17(6):1591-6. doi: 10.1093/humrep/17.6.1591.
PubMed 12042283Carlomagno G, Unfer V, Roseff S. The D-chiro-inositol paradox in the ovary. Fertil Steril. 2011 Jun 30;95(8):2515-6. doi: 10.1016/j.fertnstert.2011.05.027. Epub 2011 Jun 8.
PubMed 21641593Gardner DK, Lane M, Stevens J, Schlenker T, Schoolcraft WB. Blastocyst score affects implantation and pregnancy outcome: towards a single blastocyst transfer. Fertil Steril. 2000 Jun;73(6):1155-8. doi: 10.1016/s0015-0282(00)00518-5.
PubMed 10856474Ravanos K, Monastra G, Pavlidou T, Goudakou M, Prapas N. Can high levels of D-chiro-inositol in follicular fluid exert detrimental effects on blastocyst quality? Eur Rev Med Pharmacol Sci. 2017 Dec;21(23):5491-5498. doi: 10.26355/eurrev_201712_13940.
PubMed 29243796
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Altered Myo-inositol/D-chiro-inositol Ratio in Follicular Fluid of Women Undergoing in Vitro Fertilization Has Detrimental Effects on Oocyte and Embryo Quality
- ClinicalTrials.gov ID
- NCT03055442
- Acronym / sponsor ID
- MI/DCI_FF
- Conditions
- Women Infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Lo.Li.Pharma s.r.lIndustry (pharma, biotech, devices)
- Study start
- Oct 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 16 Feb 2017 (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.
Considering the importance assumed by follicular microenvironment for a proper oocyte development, this study is a prospective observational clinical trial which aims to evaluate whether the embryo blastocyst quality may be affected by different Myo-inositol (MI) and D-chiro-inositol (DCI) levels in the follicular fluid (FF) of the aspired oocytes. The study includes egg donors and egg receiving couples participating in the oocyte donation program. MI/DCI is calculated in FF and related with blastocyst grade.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Follicular Fluids | – | Other: Dosage of myo-inositol, Other: Dosage of D-chiro-inositolFollicular fluids obtained by 8 oocyte donors |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study included 8 egg donors participating in the donation program of IAKENTRO not for the first time, and 11 recipient couples undergoing in vitro fertilization (ICSI). Follicular fluid (FF) specimens were analysed.
Key inclusion criteria (2 listed)
- clear follicular aspirate obtained during oocyte retrieval;
- each specimen of follicular fluid containing only one oocyte.
Key exclusion criteria (3 listed)
- hyperglycaemic women;
- PCOS women also if euglycaemic;
- diabetic subjects having low concentrations of detectable MI in association with an anomalous MI transport.
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 |
|---|---|---|
| Dosage of myo-inositolQuantitative analysis of myo-inositol was performed by gas chromatography-mass spectrometry (GC-MS) | Other | Follicular Fluids |
| Dosage of D-chiro-inositolQuantitative analysis of D-chiro-inositol was performed by gas chromatography-mass spectrometry (GC-MS) | Other | Follicular Fluids |
Primary outcome
Myo-inositol concentration (µmol/l) in follicular fluid
Time frame: 5th day from pick up
After transvaginal aspiration of oocyte and follicular fluid and subsequent ICSI, at the day 5 the cultured embryos were graded according to Gardner's grading system for blastocysts. Then follicular fluids specimens were divided following the different scores given to the respective blastocysts, and their content in myo-inositol was quantified. In each sample of follicular fluid myo-inositol levels were assessed. The quantitative analysis was performed by means of gas chromatography-mass spectrometry (GC-MS) and the values were expressed as µmol/l. This value was related to the respective blastocyst grade.
D-chiro-inositol concentration (µmol/l) in follicular fluid
Time frame: 5th day from pick up
After transvaginal aspiration of oocyte and follicular fluid and subsequent ICSI, at the day 5 the cultured embryos were graded according to Gardner's grading system for blastocysts. Then follicular fluids specimens were divided following the different scores given to the respective blastocysts, and their content in D-chiro-inositol was quantified. In each sample of follicular fluid D-chiro-inositol levels were assessed. The quantitative analysis was performed by means of gas chromatography-mass spectrometry (GC-MS) and the values were expressed as µmol/l. This value was related to the respective blastocyst grade.
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 16 Feb 2017.
- Background: PubMed 12042283Chiu TT, Rogers MS, Law EL, Briton-Jones CM, Cheung LP, Haines CJ. Follicular fluid and serum concentrations of myo-inositol in patients undergoing IVF: relationship with oocyte quality. Hum Reprod. 2002 Jun;17(6):1591-6. doi: 10.1093/humrep/17.6.1591.
- Background: PubMed 21641593Carlomagno G, Unfer V, Roseff S. The D-chiro-inositol paradox in the ovary. Fertil Steril. 2011 Jun 30;95(8):2515-6. doi: 10.1016/j.fertnstert.2011.05.027. Epub 2011 Jun 8.
- Background: PubMed 10856474Gardner DK, Lane M, Stevens J, Schlenker T, Schoolcraft WB. Blastocyst score affects implantation and pregnancy outcome: towards a single blastocyst transfer. Fertil Steril. 2000 Jun;73(6):1155-8. doi: 10.1016/s0015-0282(00)00518-5.
- Derived from this study: PubMed 29243796Ravanos K, Monastra G, Pavlidou T, Goudakou M, Prapas N. Can high levels of D-chiro-inositol in follicular fluid exert detrimental effects on blastocyst quality? Eur Rev Med Pharmacol Sci. 2017 Dec;21(23):5491-5498. doi: 10.26355/eurrev_201712_13940.
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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?
An observational study of Women Infertility, run by Lo.Li.Pharma s.r.l at 1 site in Greece.
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 3 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 16 Feb 2017. 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 Greece. 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?
Myo-inositol concentration (µmol/l) in follicular fluid (time frame: 5th day from pick up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03055442, which also lists 4 linked publications.
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 16 Feb 2017.