Polycystic Ovarian SyndromePhase 2/3NCT03201601
Evaluation of the Mixture Myoinositol:D-chiro-inositol 3.6:1 in Women With Polycystic Ovary Syndrome
A Phase 2/3 study testing D-chiro-inositol and Myoinositol in people with Polycystic Ovarian Syndrome and Infertility, run by Biosearch S.A..
Trial summary
The aim of the present study is to evaluate the effect of increasing the proportion of D-chiro-inositol (DCI) in a combination with myo-inositol (MYO) in improving fertility in women with polycystic ovarian syndrome (PCOS). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Polycystic Ovarian Syndrome, Infertility
- What is being tested?
- D-chiro-inositol and Myoinositol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to 5 May 2017
- Phase
- Phase 2/3
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being diagnosed with PCOS according to Rotterdam criteria.
- Being in in vitro fertilization treatment.
- Body mass index less than 30 kg/m2.
- Accept freely to participate in the study and sign the informed consent document.
Who cannot join
- Contraindication to perform techniques of assisted reproduction or stimulation of ovulation.
- Advanced state of endometriosis (III or IV).
- Classified as poor responder in fertility treatment.
- Premature ovarian failure.
- Severe male factor (cryptozoospermia).
- Few expectations of compliance and/or collaboration.
About this study
Official title: Comparison of the Effect of a Combination of Myoinositol:D-chiro-inositol With Low Proportion of DCI (40:1) Versus a Combination With a Higher Proportion of DCI (3.6:1) in the Oocyte Quality and Pregnancy Rates in Women With PCOS
The aim of the present study is to evaluate the effect of increasing the proportion of D-chiro-inositol (DCI) in a combination with myo-inositol (MYO) in improving fertility in women with polycystic ovarian syndrome (PCOS). Sixty women diagnosed with PCOS will randomly take twice a day for 12 weeks a capsule containing 550 mg of myo-inositol and 150 mg of D-chiro-inositol or capsules containing 550 mg of myo-inositol and 13.8 mg of D-chiro-inositol.
Read the detailed description
Polycystic ovarian syndrome (PCOS) is the most prevalent endocrinopathy in women of childbearing age. It affects 4-8% of the population and of them, approximately 74% present anovulatory cycles and, therefore, fertility problems.
Both myo-inositol and D-chiro-inositol are 2 natural substances that have been shown to improve ovarian function and metabolism in women with polycystic ovarian syndrome.
The aim of the present study is to compare the effect of 2 ratios of myo-inositol /D-chiro-inositol on parameters related to the fertility of women with PCOS.
It is a multicenter, controlled, randomized, double-blind, parallel-group, 12-week clinical trial which will be conducted in 13 public and private hospitals from Spain.
- Conditions
- Polycystic Ovarian Syndrome, Infertility
- Being tested
- D-chiro-inositol, Myoinositol
- Keywords
- Polycystic ovarian syndrome, D-chiro-inositol, Fertility
- Medical subject headings
- Polycystic Ovary Syndrome, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-chiro-inositolDrug
Also called Cis-1,2,4-trans-3,5,6-cyclohexanehexol
Each participant will consume 2 capsules daily of each treatment, in the morning and at night without any restriction in the diet nor in their habits of life. The treatment will last 12 weeks.
MyoinositolDrug
Also called cis-1,2,3,5-trans-4,6-cyclohexanehexol
Each participant will consume 2 capsules daily of each treatment, in the morning and at night without any restriction in the diet nor in their habits of life. The treatment will last 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 550 mg of MYO and 150 mg of DCI | Experimental | Volunteers will take twice at day for 12 weeks a capsule containing 550 mg of myo-inositol and 150 mg of D-chiro-inositol. Receives: Drug: D-chiro-inositol; Drug: Myoinositol |
| 550 mg of MYO and 13.8 mg of DCI | Active comparator | Volunteers will take twice at day for 12 weeks a capsule containing 550 mg of myo-inositol and 13.8 mg of D-chiro-inositol. Receives: Drug: D-chiro-inositol; Drug: Myoinositol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate
Number of pregnancies
Measured: 12 weeks
Secondary outcomes (9)
Mature MII oocytes
Number of mature MII oocytes
Measured: 12 weeks
IM/VG oocytes
Number of IM/VG oocytes
Measured: 12 weeks
Grade I, II, III embryos
Number of embryos of degree I, II, III
Measured: 12 weeks
Days of stimulation
Days of stimulation
Measured: 12 weeks
Gestational sacs
Number of gestational sacs
Measured: 12 weeks
Transferred embryos
Number of embryos transferred
Measured: 12 weeks
Total testosterone
Total testosterone levels
Measured: 12 weeks
Glucose
Glucose levels
Measured: 12 weeks
Insulin
Insulin levels
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study startFeb 2016
- Primary completionMay 2017
- Study completion5 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovarian SyndromeStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosearch S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicolás Mendoza, MD, PhD, Principal investigator, Professor of Gynecology at the Faculty of Medicine of the University of Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03201601
- Sponsor's protocol ID
- C015
- Status last verified
- Oct 2016
- First submitted
- 27 Jun 2017
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of a Combination of Myoinositol:D-chiro-inositol With Low Proportion of DCI (40:1) Versus a Combination With a Higher Proportion of DCI (3.6:1) in the Oocyte Quality and Pregnancy Rates in Women With PCOS
- ClinicalTrials.gov ID
- NCT03201601
- Acronym / sponsor ID
- C015
- Conditions
- Polycystic Ovarian Syndrome, Infertility
- Keywords
- Polycystic ovarian syndrome, D-chiro-inositol, Fertility
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Biosearch S.A.Industry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- May 2017 (actual)
- Study completion
- 5 May 2017 (actual)
- First posted
- 28 Jun 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.
The aim of the present study is to evaluate the effect of increasing the proportion of D-chiro-inositol (DCI) in a combination with myo-inositol (MYO) in improving fertility in women with polycystic ovarian syndrome (PCOS). Sixty women diagnosed with PCOS will randomly take twice a day for 12 weeks a capsule containing 550 mg of myo-inositol and 150 mg of D-chiro-inositol or capsules containing 550 mg of myo-inositol and 13.8 mg of D-chiro-inositol.
Detailed description
Polycystic ovarian syndrome (PCOS) is the most prevalent endocrinopathy in women of childbearing age. It affects 4-8% of the population and of them, approximately 74% present anovulatory cycles and, therefore, fertility problems.
Both myo-inositol and D-chiro-inositol are 2 natural substances that have been shown to improve ovarian function and metabolism in women with polycystic ovarian syndrome.
The aim of the present study is to compare the effect of 2 ratios of myo-inositol /D-chiro-inositol on parameters related to the fertility of women with PCOS.
It is a multicenter, controlled, randomized, double-blind, parallel-group, 12-week clinical trial which will be conducted in 13 public and private hospitals from Spain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 550 mg of MYO and 150 mg of DCI | Experimental | Drug: D-chiro-inositol, Drug: MyoinositolVolunteers will take twice at day for 12 weeks a capsule containing 550 mg of myo-inositol and 150 mg of D-chiro-inositol. |
| 550 mg of MYO and 13.8 mg of DCI | Active comparator | Drug: D-chiro-inositol, Drug: MyoinositolVolunteers will take twice at day for 12 weeks a capsule containing 550 mg of myo-inositol and 13.8 mg of D-chiro-inositol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being diagnosed with PCOS according to Rotterdam criteria.
- Being in in vitro fertilization treatment.
- Body mass index less than 30 kg/m2.
- Accept freely to participate in the study and sign the informed consent document.
Key exclusion criteria (6 listed)
- Contraindication to perform techniques of assisted reproduction or stimulation of ovulation.
- Advanced state of endometriosis (III or IV).
- Classified as poor responder in fertility treatment.
- Premature ovarian failure.
- Severe male factor (cryptozoospermia).
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 |
|---|---|---|
| D-chiro-inositolAlso: Cis-1,2,4-trans-3,5,6-cyclohexanehexolEach participant will consume 2 capsules daily of each treatment, in the morning and at night without any restriction in the diet nor in their habits of life. The treatment will last 12 weeks. | Drug | 550 mg of MYO and 13.8 mg of DCI, 550 mg of MYO and 150 mg of DCI |
| MyoinositolAlso: cis-1,2,3,5-trans-4,6-cyclohexanehexolEach participant will consume 2 capsules daily of each treatment, in the morning and at night without any restriction in the diet nor in their habits of life. The treatment will last 12 weeks. | Drug | 550 mg of MYO and 13.8 mg of DCI, 550 mg of MYO and 150 mg of DCI |
Primary outcome
Pregnancy rate
Time frame: 12 weeks
Number of pregnancies
9 secondary outcomes
Mature MII oocytes
Time frame: 12 weeks
IM/VG oocytes
Time frame: 12 weeks
Grade I, II, III embryos
Time frame: 12 weeks
Days of stimulation
Time frame: 12 weeks
Gestational sacs
Time frame: 12 weeks
Transferred embryos
Time frame: 12 weeks
Total testosterone
Time frame: 12 weeks
Glucose
Time frame: 12 weeks
Insulin
Time frame: 12 weeks
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 10 Jan 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.
Nicolás Mendoza, MD, PhD principal investigator
Professor of Gynecology at the Faculty of Medicine of the University of Granada
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing D-chiro-inositol and Myoinositol in people with Polycystic Ovarian Syndrome and Infertility, run by Biosearch S.A..
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 6 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 10 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Pregnancy rate (time frame: 12 weeks). 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 10 Jan 2019.