Myo-Inositol- Based Co-treatment in Women With PCOS Undergoing Assisted Reproductive Technology

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Myo-Inositol- Based Co-treatment on Oocyte Quality in Women With Polycystic Ovarian Syndrome Undergoing Assisted Reproductive Technology

Conditions
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Sterility, Infertility

Intervention / Treatment
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* Drug: Myo-inositol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Azoospermia. Other medical conditions causing ovulatory disorders, such as hyperprolactinemia, hypothyroidism, or adrenal hyperplasia. Hypersensitivity to Myo-Inositol or its derivatives.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Myo-Inositol<br>1g Myo-inositol per day, in combination with alpha- lipoic acid and cysteine, (Celine Tablets; Surveal Pharmaceuticals; Belgium) + 400 ug of Folic acid | Drug: Myo-inositol<br>* 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.<br>* Other names: Celine;|
| No Intervention: No intervention<br>Standard care: 400 ug of Folic acid | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oocyte yield |  | 1 day from ovum pick up | 
| Maturation rate |  | 1 day from ovum pick up | 
| Fertilization rate |  | 16-18 hours post insemination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood profile (fasting sugar and insulin levels, Testosterone, Sex Hormone-Binding protein, DHEAs, and Androstenedione) |  | Prior to and 6 weeks post enrollment | 
| Number of gonadotropin ampules |  | 1 day from oocyte maturation trigger | 
| Obstetrical outcome (preterm birth) |  | From 24 to 36 weeks gestation | 
| Obstetrical outcome (low birth weight) |  | From 24 to 36 weeks gestation | 
| Obstetrical outcome (gestational diabetes) |  | From 24 to 36 weeks gestation | 
| Obstetrical outcome (preeclampsia) |  | From 24 to 36 weeks gestation | 
| Obstetrical outcome (admission to neonatal intensive care) |  | From 24 to 36 weeks gestation | 
| Number of stimulation days |  | 1 day from oocyte maturation trigger | 
| Embryo quality |  | 3 to 5 days from ovum pick up | 
| Miscarriage rate |  | 7 weeks post LMP | 
| Ongoing pregnancy |  | 20 weeks post LMP | 
| Live birth rate |  | 24 to 42 weeks gestation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polycystic Ovary Syndrome, Myo-Inositol, Assisted Reproductive Technology, oocyte performance, pregnancy