Ovulation InductionPhase 4NCT04306692
Myo-inositol Versus Clomiphene Citrate in PCOS
A Phase 4 study testing Myo-inositol and Clomiphene Citrate in people with Ovulation Induction and Polycystic Ovary Syndrome, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Specific aim: To compare inositol and the golden standard first line treatment of ovulation induction, namely clomiphene citrate. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Ovulation Induction, Polycystic Ovary Syndrome, Clomiphene
- What is being tested?
- Myo-inositol and Clomiphene Citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- 2 Jul 2020to 31 Jan 2022
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Rotterdam criteria for PCOS (cf. the recent ESHRE guidelines): at least 2 out of 3 criteria should be fulfilled: irregular cycle (shorter than 21 days or longer than 35 days); clinical (modified Ferriman-Gallwey score ≥ 6) or biochemical signs (elevated free testosterone) of hyperandrogenism (www.eshre.eu/Guidelines-and- Legal/Guidelines/Polycystic-Ovary-Syndrome.aspx); PCO ovaries on ultrasound (www.eshre.eu/Guidelines-and- Legal/Guidelines/Polycystic-Ovary-Syndrome.aspx): multiple small cysts (≥ 20 per ovary and/or an ovarian volume ≥ 10 ml, measured with a probe >8 MHz) in both ovaries.
- A first treatment cycle, possibly combined with intra uterine insemination (IUI) and this for (one of) the following reasons: mild male factor (as defined by each local center) endometriosis AFS score 1 or 2
- Use of own or donor sperm.
Who cannot join
- Tubal factors
- Uterine factors
- Endometriosis AFS score 3 or 4
- Moderate to severe male factor (as defined by each local center)
- BMI > 35
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Myo-inositol Versus Clomiphene Citrate as First Line Treatment for Ovulation Induction in PCOS
Specific aim: To compare inositol and the golden standard first line treatment of ovulation induction, namely clomiphene citrate.
- Conditions
- Ovulation Induction, Polycystic Ovary Syndrome, Clomiphene, Inositol
- Being tested
- Myo-inositol, Clomiphene Citrate
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myo-inositolDrug
2 x 1 bag per day, per os (subjects can take myo-inositol during the meal but it is not obliged).
Clomiphene CitrateDrug
Each tablet contains 50 mg of clomiphene citrate which means 33,9 mg of clomiphene. Other constituents are sucrose, lactose monohydrate, corn starch, pregelatinized starch, yellow iron oxide (E172) and magnesium stearate (E470b).
Dosing: 1 tablet per day from cycle day 3 until 7 (extremes included), stepping up until a maximum dose of 3 tablets per day for 5 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Inositol group | Experimental | Myo-inositol 4000 mg Dosing: 2 x 1 bag per day, per os (subjects can take myo-inositol during the meal but it is not obliged) during 3 consecutive treatment cycles. Receives: Drug: Myo-inositol |
| Clomiphene citrate group | Active comparator | Each tablet contains 50 mg of clomiphene citrate Dosing: 1 tablet per day, per os, from cycle day 3 until 7 (extremes included), stepping up until a maximum dose of 3 tablets per day for 5 consecutive days during 3 consecutive treatment cycles. Receives: Drug: Clomiphene Citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of cumulative ongoing pregnancy (a pregnancy diagnosed by ultrasonic visualisation of one or more gestational sacs with fetal heart beat) after 3 treatment cycles with inositol versus clomiphene citrate for ovulation induction.
Recently, a meta-analysis on the use of inositol in PCOS was published. This study showed that inositol leads to a more regular menstrual cycle and recovery of ovarian function. Less data are present on pregnancy rates. No RCT was found on the comparison between inositol and the golden standard first line treatment of ovulation induction, namely clomiphene citrate. Another advantage of inositol is that it doesn't have side effects compared to metformin and that there is no elevated risk on multiple pregnancies, which is the case with clomiphene citrate.
Measured: At 7 - 8 gestational weeks
Secondary outcomes (4)
The number of potential adverse events
The potential adverse events will be measured to determine whether the compliance for the patient is acceptable.
Measured: During 3 consecutive treatment cycles (each treatment cycle is up to 5 weeks)
The occurrence of ovulation
The occurence of ovulation will be measured to determine whether the compliance for the patient is acceptable.
Measured: During 3 consecutive treatment cycles (each treatment cycle is up to 5 weeks)
The number of cancelled treatment cycles
The number of cancelled treatment cycles will be measured to determine whether the compliance for the patient is acceptable.
Measured: During 3 consecutive treatment cycles (each treatment cycle is up to 5 weeks)
The number of multiple pregnancies
The number of multiple pregnancies will be measured to determine whether the compliance for the patient is acceptable.
Measured: During 3 consecutive treatment cycles (each treatment cycle is up to 5 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start2 Jul 2020
- Primary completion20 Apr 2021
- Study completion31 Jan 2022
Why it stopped: clomiphene citrate is no longer being considered as standard treatment for polycystic ovary syndrome
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovulation InductionStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Gedeon Richter Plc., University Hospital, Antwerp, AZ Jan Palfijn Gent, Our Lady of Lourdes Hospital Waregem
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306692
- Sponsor's protocol ID
- 2018-004604-20
- Other IDs
- 2018
- Status last verified
- Dec 2022
- First submitted
- 12 Feb 2020
- Last updated
- 21 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myo-inositol Versus Clomiphene Citrate as First Line Treatment for Ovulation Induction in PCOS
- ClinicalTrials.gov ID
- NCT04306692
- Acronym / sponsor ID
- 2018-004604-20
- Conditions
- Ovulation Induction, Polycystic Ovary Syndrome, Clomiphene, Inositol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: clomiphene citrate is no longer being considered as standard treatment for polycystic ovary syndrome
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Gedeon Richter Plc., University Hospital, Antwerp, AZ Jan Palfijn Gent, Our Lady of Lourdes Hospital Waregem
- Study start
- 2 Jul 2020 (actual)
- Primary completion
- 20 Apr 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 13 Mar 2020 (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.
Specific aim: To compare inositol and the golden standard first line treatment of ovulation induction, namely clomiphene citrate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inositol group | Experimental | Drug: Myo-inositolMyo-inositol 4000 mg Dosing: 2 x 1 bag per day, per os (subjects can take myo-inositol during the meal but it is not obliged) during 3 consecutive treatment cycles. |
| Clomiphene citrate group | Active comparator | Drug: Clomiphene CitrateEach tablet contains 50 mg of clomiphene citrate Dosing: 1 tablet per day, per os, from cycle day 3 until 7 (extremes included), stepping up until a maximum dose of 3 tablets per day for 5 consecutive days during 3 consecutive treatment cycles. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Rotterdam criteria for PCOS (cf. the recent ESHRE guidelines): at least 2 out of 3 criteria should be fulfilled: irregular cycle (shorter than 21 days or longer than 35 days); clinical (modified Ferriman-Gallwey score ≥ 6) or biochemical signs (elevated free testosterone) of hyperandrogenism (www.eshre.eu/Guidelines-and- Legal/Guidelines/Polycystic-Ovary-Syndrome.aspx); PCO ovaries on ultrasound (www.eshre.eu/Guidelines-and- Legal/Guidelines/Polycystic-Ovary-Syndrome.aspx): multiple small cysts (≥ 20 per ovary and/or an ovarian volume ≥ 10 ml, measured with a probe >8 MHz) in both ovaries.
- A first treatment cycle, possibly combined with intra uterine insemination (IUI) and this for (one of) the following reasons: mild male factor (as defined by each local center) endometriosis AFS score 1 or 2
- Use of own or donor sperm.
Key exclusion criteria (5 listed)
- Tubal factors
- Uterine factors
- Endometriosis AFS score 3 or 4
- Moderate to severe male factor (as defined by each local center)
- BMI > 35
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-inositol2 x 1 bag per day, per os (subjects can take myo-inositol during the meal but it is not obliged). | Drug | Inositol group |
| Clomiphene CitrateEach tablet contains 50 mg of clomiphene citrate which means 33,9 mg of clomiphene. Other constituents are sucrose, lactose monohydrate, corn starch, pregelatinized starch, yellow iron oxide (E172) and magnesium stearate (E470b). Dosing: 1 tablet per day from cycle day 3 until 7 (extremes included), stepping up until a maximum dose of 3 tablets per day for 5 consecutive days. | Drug | Clomiphene citrate group |
Primary outcome
Rate of cumulative ongoing pregnancy (a pregnancy diagnosed by ultrasonic visualisation of one or more gestational sacs with fetal heart beat) after 3 treatment cycles with inositol versus clomiphene citrate for ovulation induction.
Time frame: At 7 - 8 gestational weeks
Recently, a meta-analysis on the use of inositol in PCOS was published. This study showed that inositol leads to a more regular menstrual cycle and recovery of ovarian function. Less data are present on pregnancy rates. No RCT was found on the comparison between inositol and the golden standard first line treatment of ovulation induction, namely clomiphene citrate. Another advantage of inositol is that it doesn't have side effects compared to metformin and that there is no elevated risk on multiple pregnancies, which is the case with clomiphene citrate.
4 secondary outcomes
The number of potential adverse events
Time frame: During 3 consecutive treatment cycles (each treatment cycle is up to 5 weeks)
The occurrence of ovulation
Time frame: During 3 consecutive treatment cycles (each treatment cycle is up to 5 weeks)
The number of cancelled treatment cycles
Time frame: During 3 consecutive treatment cycles (each treatment cycle is up to 5 weeks)
The number of multiple pregnancies
Time frame: During 3 consecutive treatment cycles (each treatment cycle is up to 5 weeks)
Results and safety
The study was stopped early (reason given: clomiphene citrate is no longer being considered as standard treatment for polycystic ovary syndrome). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
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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 Phase 4 study testing Myo-inositol and Clomiphene Citrate in people with Ovulation Induction and Polycystic Ovary Syndrome, run by University Hospital, Ghent at 1 site in Belgium.
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 3 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: stopped early, as of the sponsor's last update on 21 Dec 2022. 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 Belgium. 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 was stopped early (reason given: clomiphene citrate is no longer being considered as standard treatment for polycystic ovary syndrome). Results are not available in the source record.
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?
Rate of cumulative ongoing pregnancy (a pregnancy diagnosed by ultrasonic visualisation of one or more gestational sacs with fetal heart beat) after 3 treatment cycles with inositol versus clomiphene citrate for ovulation induction. (time frame: At 7 - 8 gestational 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 21 Dec 2022.