Back to resultsMyo-inositol Versus Clomiphene Citrate in PCOS
Primary Purpose
Ovulation Induction, Polycystic Ovary Syndrome, Clomiphene
Status
Terminated
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Myo-inositol
Clomiphene Citrate
Sponsored by
About this trial
This is an interventional treatment trial for Ovulation Induction
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Tubal factors
- Uterine factors
- Endometriosis AFS score 3 or 4
- Moderate to severe male factor (as defined by each local center)
- BMI > 35
Sites / Locations
- University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Inositol group
Clomiphene citrate group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
The number of potential adverse events
The potential adverse events will be measured to determine whether the compliance for the patient is acceptable.
The occurrence of ovulation
The occurence of ovulation will be measured to determine whether the compliance for the patient is acceptable.
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.
The number of multiple pregnancies
The number of multiple pregnancies will be measured to determine whether the compliance for the patient is acceptable.
Full Information
NCT ID
NCT04306692
First Posted
February 12, 2020
Last Updated
December 16, 2022
Sponsor
University Hospital, Ghent
Collaborators
Gedeon Richter Plc., University Hospital, Antwerp, AZ Jan Palfijn Gent, Our Lady of Lourdes Hospital Waregem
1. Study Identification
Unique Protocol Identification Number
NCT04306692
Brief Title
Myo-inositol Versus Clomiphene Citrate in PCOS
Official Title
Myo-inositol Versus Clomiphene Citrate as First Line Treatment for Ovulation Induction in PCOS
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
clomiphene citrate is no longer being considered as standard treatment for polycystic ovary syndrome
Study Start Date
July 2, 2020 (Actual)
Primary Completion Date
April 20, 2021 (Actual)
Study Completion Date
January 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
Gedeon Richter Plc., University Hospital, Antwerp, AZ Jan Palfijn Gent, Our Lady of Lourdes Hospital Waregem
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Specific aim: To compare inositol and the golden standard first line treatment of ovulation induction, namely clomiphene citrate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovulation Induction, Polycystic Ovary Syndrome, Clomiphene, Inositol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inositol group
Arm Type
Experimental
Arm Description
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.
Arm Title
Clomiphene citrate group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Myo-inositol
Intervention Description
2 x 1 bag per day, per os (subjects can take myo-inositol during the meal but it is not obliged).
Intervention Type
Drug
Intervention Name(s)
Clomiphene Citrate
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
At 7 - 8 gestational weeks
Secondary Outcome Measure Information:
Title
The number of potential adverse events
Description
The potential adverse events will be measured to determine whether the compliance for the patient is acceptable.
Time Frame
During 3 consecutive treatment cycles (each treatment cycle is up to 5 weeks)
Title
The occurrence of ovulation
Description
The occurence of ovulation will be measured to determine whether the compliance for the patient is acceptable.
Time Frame
During 3 consecutive treatment cycles (each treatment cycle is up to 5 weeks)
Title
The number of cancelled treatment cycles
Description
The number of cancelled treatment cycles will be measured to determine whether the compliance for the patient is acceptable.
Time Frame
During 3 consecutive treatment cycles (each treatment cycle is up to 5 weeks)
Title
The number of multiple pregnancies
Description
The number of multiple pregnancies will be measured to determine whether the compliance for the patient is acceptable.
Time Frame
During 3 consecutive treatment cycles (each treatment cycle is up to 5 weeks)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Tubal factors
Uterine factors
Endometriosis AFS score 3 or 4
Moderate to severe male factor (as defined by each local center)
BMI > 35
Facility Information:
Facility Name
University Hospital
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
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Myo-inositol Versus Clomiphene Citrate in PCOS
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