Myo-inositol Therapy on the Dynamics of Embryo Development in Patients Suffering From PCOS Undergoing ICSI Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to analyse the activity of myo-inositol on pregnancy rate, embryo development dynamics and oestradiol and progesterone concentration in blood serum and Superoxide Dismutase (SOD) and catalase concentration in follicular fluid of patients with Polycystic Ovary Syndrome (PCOS) undergoing Intracytoplasmic Sperm Injection (ICSI).

Official Title
-----------------
Evaluation Concerning the Influence of Myo-inositol Therapy on the Dynamics of Embryo Development in Patients Suffering From PCOS Undergoing ICSI Treatment

Conditions
-----------------
Polycystic Ovary Syndrome, Infertility

Intervention / Treatment
-----------------
* Dietary Supplement: Inofolic: myo-inositol and folic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICSI treatment due to infertility PCOS patients enrolled according to the criteria established by representatives of the American Society of Reproductive Medicine (ASRM) and the European Society of Human Reproduction and Embryology (ESHRE) Exclusion Criteria: Severe endometriosis BMI <17 and >30 Metabolic diseases Lowered ovarian reserve

Ages Eligible for Study
-----------------
Minimum Age: 27 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group I<br>60 patients diagnosed with PCOS, not myo-inositol treated undergoing ICSI | |
| Experimental: Group II<br>52 patients diagnosed with PCOS undergoing ICSI, taking Inofolic (myo-inositol + folic acid) | Dietary Supplement: Inofolic: myo-inositol and folic acid<br>* 4000 mg of myo-inositol and 0,4 mg of folic acid for 3 months preceding the ICSI procedure<br>|
| Placebo Comparator: Group III<br>105 patients not diagnosed with PCOS undergoing ICSI, not taking myo-inositol | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oestradiol (E2) level in blood serum (pg/ml) |  | Between 11th and 19th day of cycle, when the largest of the oocyte in the evaluation of ultrasound exceeded 17mm diameter, | 
| Progesterone (ng/ml) level in blood serum |  | Between 11th and 19th day of cycle, when the largest of the oocyte in the evaluation of ultrasound exceeded 17mm diameter | 
| Superoxide dismutase (SOD) activity level in follicular fluid (mIU/mg) | The decision was taken when three conditions are met: the biggest oocyte exceeds 17mm, the endometrium was over 9mm (two layers) and estradiol level was greater than 150 | On puncture day or on collection day of oocytes, in practice, between 11th and 19th day of cycle | 
| Catalase activity level in follicular fluid (mIU/mg) | The decision was taken when three conditions are met: the biggest oocyte exceeds 17mm, the endometrium was over 9mm (two layers) and estradiol level was greater than 150 | On puncture day or on collection day of oocytes, in practice, between 11th and 19th day of cycle | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Period of blastocyst and embryo development | Embryo culture was evaluated by means of constant monitoring performed in 10-minute intervals with a camera placed inside the incubator.The t0 time was described as the hour of the ICSI. tF was defined as the first moment when pronuclei were already visible, whereas tC as the last moment of their visibility. The moment when a single cell embryo appeared after syngamy was determined as t1, and then the superseding divisions were marked as t2, t3, t4, t5, t6, t7, t8. tM stood for the beginning of morula formation, whereas tB was the time during which the first signs of blastocyst cavity could be seen. | From the moment of puncture, between the 11th and 19th day of the cycle, for a maximum of seven days | 
| Pregnancy rate | Ultrasound examination of the echo of the embryo and heart rate | During the 7th week of pregnancy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Polycystic Ovary Syndrome, Infertility, Myo-inositol, Intracytoplasmic sperm injection