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Use of Myo-inositol as Adjuvant Therapy in Patients With Polycystic Ovary Syndrome (PCOS) in Vitro Fertilization (IVF) (FIV-INOPK)

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ClinicalTrials.gov Identifier: NCT02221154
Recruitment Status : Terminated (Difficulty recruiting)
First Posted : August 20, 2014
Last Update Posted : June 16, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Departemental Vendee

Brief Summary:

The original mechanism of action of myo-inositol and preliminary results available in the literature on its use in IVF suggest its value as adjuvant gonadotropin therapy to reduce the risk of OHSS in PCOS patients.

The aim of the study is to demonstrate that administration of myo-inositol decreases the incidence of ovarian hyperstimulation syndrome (OHSS) in high-risk infertile with PCOS supported in IVF patients.


Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Dietary Supplement: Inofolic® Other: Gonadotropins; Folic Acid Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Use of Myo-inositol as Adjuvant Therapy in Patients With Polycystic Ovary Syndrome (PCOS) in Vitro Fertilization (IVF)
Study Start Date : November 2014
Actual Primary Completion Date : May 22, 2017
Actual Study Completion Date : May 22, 2017

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Arm Intervention/treatment
Experimental: Inofolic®
standard ovarian stimulation and Inofolic®
Dietary Supplement: Inofolic®
Other: Gonadotropins; Folic Acid
standard ovarian stimulation

Active Comparator: Gonadotropins;Folic Acid
standard ovarian stimulation without Inofolic®
Other: Gonadotropins; Folic Acid
standard ovarian stimulation




Primary Outcome Measures :
  1. Incidence of OHSS in each group, graded mild, moderate or severe based on the recommendations [ Time Frame: 3 month ]


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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients PCOS (Rotterdam ESHRE / ASRM criteria)

Combination of at least two of the following three criteria:

  • Cycle disorder
  • Clinical hyperandrogenism and / or biological
  • Account antral follicles> 24
  • Age ≤ 18 ≤ 38 years
  • BMI <35 kg / m²
  • Able to understand the protocol and signed informed consent

Exclusion Criteria:

  • Patients not having the Rotterdam criteria
  • Patients> 38 years and / or BMI> 35 kg / m²
  • Woman enjoying a measure of legal protection
  • Hypersensitivity to any component of the Inofolic (myo-inositol, soy, folic acid, glycerol, gelatin, coloring E171)
  • Participation in another interventional biomedical research with treatment administered may disrupt ovarian stimulation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02221154


Locations
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France
CHI de Créteil
Créteil, France, 94000
CHD Vendée
La Roche sur Yon, France, 85925
CHU de Nantes
Nantes, France, 44093
CH de Saint Nazaire
Saint Nazaire, France, 44606
Sponsors and Collaborators
Centre Hospitalier Departemental Vendee
Investigators
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Principal Investigator: Fabienne DELAY, PH CHD Vendée La Roche sur Yon

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Responsible Party: Centre Hospitalier Departemental Vendee
ClinicalTrials.gov Identifier: NCT02221154     History of Changes
Other Study ID Numbers: CHD 096-13
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: July 2016

Keywords provided by Centre Hospitalier Departemental Vendee:
in vitro fertilization
ovarian hyperstimulation
pregnancy

Additional relevant MeSH terms:
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Inositol
Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Folic Acid
Vitamin B Complex
Hematinics
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs