SterilityPhase 4NCT03177122
Myo-Inositol- Based Co-treatment in Women With PCOS Undergoing Assisted Reproductive Technology
A Phase 4 study testing Myo-inositol in people with Sterility and Infertility, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
This is a prospective comparative randomized controlled study investigating the effect of Myo-Inositol-based co-treatment on oocyte quality measures in women with PCOS. Read more about this study
- Who is it for?
- Ages 18 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sterility, Infertility
- What is being tested?
- Myo-inositol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Mar 2017to 31 Dec 2023
- 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 18 to 18 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-40 years at the time of enrollment.
- Women diagnosed with PCOS according to the Rotterdam criteria indicated by oligoamenorrhea (six or fewer menstrual cycles during a period of 1 year), hyperandrogenism (hirsutism, acne, or alopecia) or hyperandrogenemia (elevated levels of total or free T) and typical features of ovaries on ultrasound scan.
- Planned IVF/ICSI treatment.
- Normal uterine cavity (as assessed by hysteroscopy or HSG).
- Normal hormonal investigation: TSH and PRL.
Who cannot join
- Azoospermia.
- Other medical conditions causing ovulatory disorders, such as hyperprolactinemia, hypothyroidism, or adrenal hyperplasia.
- Hypersensitivity to Myo-Inositol or its derivatives.
Trial locations and contacts
1 site in 1 country.
Lebanon1 site, 1 recruiting
- Recruiting
American University of Beirut Medical Center
Beirut
Johnny Awwad, MD, 00961 1 350000 ext. 5606, jawwad@aub.edu.lb
About this study
Official title: Effect of Myo-Inositol- Based Co-treatment on Oocyte Quality in Women With Polycystic Ovarian Syndrome Undergoing Assisted Reproductive Technology
This is a prospective comparative randomized controlled study investigating the effect of Myo-Inositol-based co-treatment on oocyte quality measures in women with PCOS.
Read the detailed description
Polycystic Ovary Syndrome is the most common cause of chronic anovulation in women. Women with PCOS undergoing IVF are at an increased risk for developing both multiple gestation and ovarian hyperstimulation syndrome (OHSS). Since insulin resistance and hyperinsulinemia have been implicated in the pathophysiology of the disorder, the administration of metformin before or during an IVF cycle has been practiced for years in an attempt to improve follicular parameters necessary for reproductive success. Recently, a growing body of evidence has implicated alternative insulin sensitizing drugs, namely Myo-Inositol, in improving various manifestations of the disorder in this women population. Little has been done to evaluate the effect of Myo-Inositol co-treatment on the reproductive performance of PCOS women undergoing Assisted Reproductive Technologies (ART). In this prospective comparative randomized controlled study, women will be randomized into two groups: Women in the control group will receive folic acid daily. Women in the study group will receive Myo-Inositol, in combination with alpha- lipoic acid and cysteine, per day plus folic acid supplemented daily along with ovarian stimulation.
- Conditions
- Sterility, Infertility
- Being tested
- Myo-inositol
- Keywords
- Polycystic Ovary Syndrome, Myo-Inositol, Assisted Reproductive Technology, oocyte performance, pregnancy
- Medical subject headings
- Infertility, Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myo-inositolDrug
Also called Celine
Patients belonging to this group will receive 1 gram of Myo-Inositol, in combination with alpha- lipoic acid and cysteine, (Celine Tablets; Surveal Pharmaceuticals; Belgium) starting 6 weeks prior to stimulation and extending until final oocyte maturation, combined with 400 µg of folic acid supplemented daily.
| Study group | Role | What they receive |
|---|---|---|
| Myo-Inositol | Experimental | 1g Myo-inositol per day, in combination with alpha- lipoic acid and cysteine, (Celine Tablets; Surveal Pharmaceuticals; Belgium) + 400 ug of Folic acid Receives: Drug: Myo-inositol |
| No intervention | No intervention | Standard care: 400 ug of Folic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oocyte yield
Measured: 1 day from ovum pick up
Maturation rate
Measured: 1 day from ovum pick up
Fertilization rate
Measured: 16-18 hours post insemination
Secondary outcomes (12)
Blood profile (fasting sugar and insulin levels, Testosterone, Sex Hormone-Binding protein, DHEAs, and Androstenedione)
Measured: Prior to and 6 weeks post enrollment
Number of gonadotropin ampules
Measured: 1 day from oocyte maturation trigger
Obstetrical outcome (preterm birth)
Measured: From 24 to 36 weeks gestation
Obstetrical outcome (low birth weight)
Measured: From 24 to 36 weeks gestation
Obstetrical outcome (gestational diabetes)
Measured: From 24 to 36 weeks gestation
Obstetrical outcome (preeclampsia)
Measured: From 24 to 36 weeks gestation
Obstetrical outcome (admission to neonatal intensive care)
Measured: From 24 to 36 weeks gestation
Number of stimulation days
Measured: 1 day from oocyte maturation trigger
Embryo quality
Measured: 3 to 5 days from ovum pick up
Miscarriage rate
Measured: 7 weeks post LMP
Ongoing pregnancy
Measured: 20 weeks post LMP
Live birth rate
Measured: 24 to 42 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start1 Mar 2017
- Primary completion1 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SterilityStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johnny Awwad, American University of Beirut Medical Center
- Investigators
- Johnny Awwad, MD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03177122
- Sponsor's protocol ID
- AmericanUBMCMYO
- Status last verified
- Jul 2023
- First submitted
- 25 May 2017
- Last updated
- 20 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shukla R, Chadha M, Adya A, Yadav A, Singh N, Chauhan RS, Ahmad A, Tiwari RK. Ongoing Clinical Trials for Polycystic Ovarian Syndrome (PCOS) Afflicted Infertility in Women: A Narrative Review. Rev Recent Clin Trials. 2025;20(2):113-123. doi: 10.2174/0115748871325070241008101355.
PubMed 39421989
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Myo-Inositol- Based Co-treatment on Oocyte Quality in Women With Polycystic Ovarian Syndrome Undergoing Assisted Reproductive Technology
- ClinicalTrials.gov ID
- NCT03177122
- Acronym / sponsor ID
- AmericanUBMCMYO
- Conditions
- Sterility, Infertility
- Keywords
- Polycystic Ovary Syndrome, Myo-Inositol, Assisted Reproductive Technology, oocyte performance, pregnancy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 6 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.
This is a prospective comparative randomized controlled study investigating the effect of Myo-Inositol-based co-treatment on oocyte quality measures in women with PCOS.
Detailed description
Polycystic Ovary Syndrome is the most common cause of chronic anovulation in women. Women with PCOS undergoing IVF are at an increased risk for developing both multiple gestation and ovarian hyperstimulation syndrome (OHSS). Since insulin resistance and hyperinsulinemia have been implicated in the pathophysiology of the disorder, the administration of metformin before or during an IVF cycle has been practiced for years in an attempt to improve follicular parameters necessary for reproductive success. Recently, a growing body of evidence has implicated alternative insulin sensitizing drugs, namely Myo-Inositol, in improving various manifestations of the disorder in this women population. Little has been done to evaluate the effect of Myo-Inositol co-treatment on the reproductive performance of PCOS women undergoing Assisted Reproductive Technologies (ART). In this prospective comparative randomized controlled study, women will be randomized into two groups: Women in the control group will receive folic acid daily. Women in the study group will receive Myo-Inositol, in combination with alpha- lipoic acid and cysteine, per day plus folic acid supplemented daily along with ovarian stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myo-Inositol | Experimental | Drug: Myo-inositol1g Myo-inositol per day, in combination with alpha- lipoic acid and cysteine, (Celine Tablets; Surveal Pharmaceuticals; Belgium) + 400 ug of Folic acid |
| No intervention | No intervention | –Standard care: 400 ug of Folic acid |
Who may qualify
- Ages
- 18 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18-40 years at the time of enrollment.
- Women diagnosed with PCOS according to the Rotterdam criteria indicated by oligoamenorrhea (six or fewer menstrual cycles during a period of 1 year), hyperandrogenism (hirsutism, acne, or alopecia) or hyperandrogenemia (elevated levels of total or free T) and typical features of ovaries on ultrasound scan.
- Planned IVF/ICSI treatment.
- Normal uterine cavity (as assessed by hysteroscopy or HSG).
- Normal hormonal investigation: TSH and PRL.
Key exclusion criteria (3 listed)
- Azoospermia.
- Other medical conditions causing ovulatory disorders, such as hyperprolactinemia, hypothyroidism, or adrenal hyperplasia.
- Hypersensitivity to Myo-Inositol or its derivatives.
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-inositolAlso: CelinePatients belonging to this group will receive 1 gram of Myo-Inositol, in combination with alpha- lipoic acid and cysteine, (Celine Tablets; Surveal Pharmaceuticals; Belgium) starting 6 weeks prior to stimulation and extending until final oocyte maturation, combined with 400 µg of folic acid supplemented daily. | Drug | Myo-Inositol |
Primary outcome
Oocyte yield
Time frame: 1 day from ovum pick up
Maturation rate
Time frame: 1 day from ovum pick up
Fertilization rate
Time frame: 16-18 hours post insemination
12 secondary outcomes
Blood profile (fasting sugar and insulin levels, Testosterone, Sex Hormone-Binding protein, DHEAs, and Androstenedione)
Time frame: Prior to and 6 weeks post enrollment
Number of gonadotropin ampules
Time frame: 1 day from oocyte maturation trigger
Obstetrical outcome (preterm birth)
Time frame: From 24 to 36 weeks gestation
Obstetrical outcome (low birth weight)
Time frame: From 24 to 36 weeks gestation
Obstetrical outcome (gestational diabetes)
Time frame: From 24 to 36 weeks gestation
Obstetrical outcome (preeclampsia)
Time frame: From 24 to 36 weeks gestation
Obstetrical outcome (admission to neonatal intensive care)
Time frame: From 24 to 36 weeks gestation
Number of stimulation days
Time frame: 1 day from oocyte maturation trigger
Embryo quality
Time frame: 3 to 5 days from ovum pick up
Miscarriage rate
Time frame: 7 weeks post LMP
Ongoing pregnancy
Time frame: 20 weeks post LMP
Live birth rate
Time frame: 24 to 42 weeks gestation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Derived from this study: PubMed 39421989Shukla R, Chadha M, Adya A, Yadav A, Singh N, Chauhan RS, Ahmad A, Tiwari RK. Ongoing Clinical Trials for Polycystic Ovarian Syndrome (PCOS) Afflicted Infertility in Women: A Narrative Review. Rev Recent Clin Trials. 2025;20(2):113-123. doi: 10.2174/0115748871325070241008101355.
- 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.
Johnny Awwad, MD principal investigator
American University of Beirut Medical Center
1 site 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 in people with Sterility and Infertility, run by American University of Beirut Medical Center at 1 site in Lebanon.
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 5 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: status not confirmed, as of the sponsor's last update on 20 Jul 2023. 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 Lebanon. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johnny Awwad, MD (009611350000 ext. 5606, jawwad@aub.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oocyte yield (time frame: 1 day from ovum pick up). 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 NCT03177122, which also lists 1 linked publication.
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 20 Jul 2023.