InfertilityPhase 4NCT01338844
Role of Myo-inositol and D-chiro-inositol on Oocyte Quality
A Phase 4 study testing Myo-inositol and D-chito-Inositol in people with Infertility, run by AGUNCO Obstetrics and Gynecology Centre at 3 sites in Italy.
Trial summary
Controlled ovarian hyperstimulation with gonadotropins is an integral part of the various stimulation protocols for patients undergoing in-vitro fertilization (IVF) and other Assisted Reproductive Technologies (ART) such as intracytoplasmic sperm injection (ICSI). Read more about this study
- Who is it for?
- Ages 25 to 45 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Myo-inositol and D-chito-Inositol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 3 sitesItaly
- Study dates
- Start not givento not given
- Phase
- Phase 4
- 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 25 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women undergoing IVF treatments
- Body mass index <28
- FSH <10IU/L
- Normal uterine cavity, anatomy and functions
Who cannot join
- PCOS
- Stage III or IV endometriosis
- Premature ovarian failure
- Poor responder
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
San Raffaele Hospital
Milan
Research Center for Reproductive Medicine Villa Mafalda
Roma
Agunco
Rome
About this study
Official title: A Prospective, Randomized, Double Blind, Study on the Clinical Efficacy Myo-inositol Versus D-chiro-inositol in Women Undergoing in Vitro Fertilization Embryo Transfer.
Controlled ovarian hyperstimulation with gonadotropins is an integral part of the various stimulation protocols for patients undergoing in-vitro fertilization (IVF) and other Assisted Reproductive Technologies (ART) such as intracytoplasmic sperm injection (ICSI).
The hormonal control of multiple follicular growth and maturation is a critical part of ART procedures since it maximizes the yield of embryos to be transferred, thus increasing the cumulative pregnancy rate.
Read more
Recent studies have shown the efficacy of myo-inositol (MI) supplementation as a simple and highly effective treatment in order to improve oocyte quality in patients undergoing IVF. Indeed, it was previously shown that MI follicular fluid (FF) concentration is a reliable predictor of oocyte quality. High MI concentration in the FF directly correlates with high oocyte and embryo quality.
Another stereoisomer of Inositol was successfully used into clinical practice D-chiro-inositol (DCI). In particular, DCI supplementation was used to restore ovulation in hyperglycemic PCOS patients.
In the present study we aim to compare MI versus DCI supplementation on oocyte quality of women undergoing IVF-ET
- Conditions
- Infertility
- Being tested
- Myo-inositol, D-chito-Inositol
- Keywords
- Poor oocyte quality, IVF failure
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myo-inositolDietary supplement
D-chito-InositolDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| D-Chiro-inositol | Experimental | Patients will receive 1.2g/day of D-chiro-inositol Receives: Dietary Supplement: D-chito-Inositol |
| Myo-inositol | Active comparator | Patients will receive 4g/day of myo-inositol Receives: Dietary Supplement: Myo-inositol |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of morphologically mature oocytes
Total international units (IU) of recombinant FSH administrated
number of grade 1 embryos
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
Sponsor and investigators
- Lead sponsor
- AGUNCO Obstetrics and Gynecology Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Research Center for Reproductive Medicine Villa Mafalda, San Raffaele University Hospital, Italy
- Investigators
- Gianfranco Carlomagno, Ph.D., Principal investigator, AGUNCO Obstetrics and Gynecology CentreVittorio Unfer, M.D., Principal investigator, AGUNCO Obstetrics and Gynecology CentreFranco Lisi, M.D., Principal investigator, Research Center for Reproductive MedicineEnrico Papaleo, M.D., Principal investigator, San Raffaele HospitalScott Roseff, MD, Principal investigator, The Palm Beach Center for Reproductive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01338844
- Sponsor's protocol ID
- MI_vs_DCI_Oo_q
- Status last verified
- Apr 2011
- First submitted
- 14 Apr 2011
- Last updated
- 1 Jun 2011
- Results posted
- No
- Data monitoring committee
- 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 12042283Unfer V, Raffone E, Rizzo P, Buffo S. Effect of a supplementation with myo-inositol plus melatonin on oocyte quality in women who failed to conceive in previous in vitro fertilization cycles for poor oocyte quality: a prospective, longitudinal, cohort study. Gynecol Endocrinol. 2011 Nov;27(11):857-61. doi: 10.3109/09513590.2011.564687. Epub 2011 Apr 5.
PubMed 21463230Rizzo P, Raffone E, Benedetto V. Effect of the treatment with myo-inositol plus folic acid plus melatonin in comparison with a treatment with myo-inositol plus folic acid on oocyte quality and pregnancy outcome in IVF cycles. A prospective, clinical trial. Eur Rev Med Pharmacol Sci. 2010 Jun;14(6):555-61.
PubMed 20712264Papaleo E, Unfer V, Baillargeon JP, Chiu TT. Contribution of myo-inositol to reproduction. Eur J Obstet Gynecol Reprod Biol. 2009 Dec;147(2):120-3. doi: 10.1016/j.ejogrb.2009.09.008. Epub 2009 Oct 2.
PubMed 19800728Papaleo E, Unfer V, Baillargeon JP, Fusi F, Occhi F, De Santis L. RETRACTED: Myo-inositol may improve oocyte quality in intracytoplasmic sperm injection cycles. A prospective, controlled, randomized trial. Fertil Steril. 2009 May;91(5):1750-1754. doi: 10.1016/j.fertnstert.2008.01.088. Epub 2008 May 7.
PubMed 18462730Nestler JE, Jakubowicz DJ, Reamer P, Gunn RD, Allan G. Ovulatory and metabolic effects of D-chiro-inositol in the polycystic ovary syndrome. N Engl J Med. 1999 Apr 29;340(17):1314-20. doi: 10.1056/NEJM199904293401703.
PubMed 10219066
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double Blind, Study on the Clinical Efficacy Myo-inositol Versus D-chiro-inositol in Women Undergoing in Vitro Fertilization Embryo Transfer.
- ClinicalTrials.gov ID
- NCT01338844
- Acronym / sponsor ID
- MI_vs_DCI_Oo_q
- Conditions
- Infertility
- Keywords
- Poor oocyte quality, IVF failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- AGUNCO Obstetrics and Gynecology CentreUniversity, hospital or other
- Collaborators
- Research Center for Reproductive Medicine Villa Mafalda, San Raffaele University Hospital, Italy
- First posted
- 20 Apr 2011 (estimated)
- 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.
Controlled ovarian hyperstimulation with gonadotropins is an integral part of the various stimulation protocols for patients undergoing in-vitro fertilization (IVF) and other Assisted Reproductive Technologies (ART) such as intracytoplasmic sperm injection (ICSI).
The hormonal control of multiple follicular growth and maturation is a critical part of ART procedures since it maximizes the yield of embryos to be transferred, thus increasing the cumulative pregnancy rate.
Recent studies have shown the efficacy of myo-inositol (MI) supplementation as a simple and highly effective treatment in order to improve oocyte quality in patients undergoing IVF. Indeed, it was previously shown that MI follicular fluid (FF) concentration is a reliable predictor of oocyte quality. High MI concentration in the FF directly correlates with high oocyte and embryo quality.
Another stereoisomer of Inositol was successfully used into clinical practice D-chiro-inositol (DCI). In particular, DCI supplementation was used to restore ovulation in hyperglycemic PCOS patients.
In the present study we aim to compare MI versus DCI supplementation on oocyte quality of women undergoing IVF-ET
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D-Chiro-inositol | Experimental | Dietary Supplement: D-chito-InositolPatients will receive 1.2g/day of D-chiro-inositol |
| Myo-inositol | Active comparator | Dietary Supplement: Myo-inositolPatients will receive 4g/day of myo-inositol |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- women undergoing IVF treatments
- Body mass index <28
- FSH <10IU/L
- Normal uterine cavity, anatomy and functions
Key exclusion criteria (4 listed)
- PCOS
- Stage III or IV endometriosis
- Premature ovarian failure
- Poor responder
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 |
|---|---|---|
| Myo-inositol | Dietary supplement | Myo-inositol |
| D-chito-Inositol | Dietary supplement | D-Chiro-inositol |
Primary outcome
number of morphologically mature oocytes
Total international units (IU) of recombinant FSH administrated
number of grade 1 embryos
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 1 Jun 2011.
- 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 21463230Unfer V, Raffone E, Rizzo P, Buffo S. Effect of a supplementation with myo-inositol plus melatonin on oocyte quality in women who failed to conceive in previous in vitro fertilization cycles for poor oocyte quality: a prospective, longitudinal, cohort study. Gynecol Endocrinol. 2011 Nov;27(11):857-61. doi: 10.3109/09513590.2011.564687. Epub 2011 Apr 5.
- Background: PubMed 20712264Rizzo P, Raffone E, Benedetto V. Effect of the treatment with myo-inositol plus folic acid plus melatonin in comparison with a treatment with myo-inositol plus folic acid on oocyte quality and pregnancy outcome in IVF cycles. A prospective, clinical trial. Eur Rev Med Pharmacol Sci. 2010 Jun;14(6):555-61.
- Background: PubMed 19800728Papaleo E, Unfer V, Baillargeon JP, Chiu TT. Contribution of myo-inositol to reproduction. Eur J Obstet Gynecol Reprod Biol. 2009 Dec;147(2):120-3. doi: 10.1016/j.ejogrb.2009.09.008. Epub 2009 Oct 2.
- Background: PubMed 18462730Papaleo E, Unfer V, Baillargeon JP, Fusi F, Occhi F, De Santis L. RETRACTED: Myo-inositol may improve oocyte quality in intracytoplasmic sperm injection cycles. A prospective, controlled, randomized trial. Fertil Steril. 2009 May;91(5):1750-1754. doi: 10.1016/j.fertnstert.2008.01.088. Epub 2008 May 7.
- Background: PubMed 10219066Nestler JE, Jakubowicz DJ, Reamer P, Gunn RD, Allan G. Ovulatory and metabolic effects of D-chiro-inositol in the polycystic ovary syndrome. N Engl J Med. 1999 Apr 29;340(17):1314-20. doi: 10.1056/NEJM199904293401703.
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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.
Gianfranco Carlomagno, Ph.D. principal investigator
AGUNCO Obstetrics and Gynecology Centre
Vittorio Unfer, M.D. principal investigator
AGUNCO Obstetrics and Gynecology Centre
Franco Lisi, M.D. principal investigator
Research Center for Reproductive Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Myo-inositol and D-chito-Inositol in people with Infertility, run by AGUNCO Obstetrics and Gynecology Centre at 3 sites 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 4 inclusion and 4 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 1 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
number of morphologically mature oocytes. 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?
On the ClinicalTrials.gov record for NCT01338844, which also lists 6 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 1 Jun 2011.