Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
12 participants
INTERVENTIONAL
2020-07-02
2022-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Inositol group
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.
Myo-inositol
2 x 1 bag per day, per os (subjects can take myo-inositol during the meal but it is not obliged).
Clomiphene citrate group
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.
Clomiphene Citrate
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.
Interventions
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Myo-inositol
2 x 1 bag per day, per os (subjects can take myo-inositol during the meal but it is not obliged).
Clomiphene Citrate
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Uterine factors
* Endometriosis AFS score 3 or 4
* Moderate to severe male factor (as defined by each local center)
* BMI \> 35
18 Years
40 Years
FEMALE
No
Sponsors
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Gedeon Richter Plc.
INDUSTRY
University Hospital, Antwerp
OTHER
AZ Jan Palfijn Gent
OTHER
Our Lady of Lourdes Hospital Waregem
UNKNOWN
University Hospital, Ghent
OTHER
Responsible Party
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Locations
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University Hospital
Ghent, , Belgium
Countries
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Other Identifiers
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2018-004604-20
Identifier Type: -
Identifier Source: org_study_id