Infertility, Polycystic Ovary Syndrome
Conditions
Keywords
Polycystic Ovary Syndrome, Infertility, Myo-inositol, Intracytoplasmic sperm injection
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).
Interventions
DIETARY_SUPPLEMENTInofolic: myo-inositol and folic acid
4000 mg of myo-inositol and 0,4 mg of folic acid for 3 months preceding the ICSI procedure
Sponsors
Medical University of Lublin
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
27 Years to 35 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | On puncture day or on collection day of oocytes, in practice, between 11th and 19th day of cycle | 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 |
| Catalase activity level in follicular fluid (mIU/mg) | On puncture day or on collection day of oocytes, in practice, between 11th and 19th day of cycle | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Period of blastocyst and embryo development | From the moment of puncture, between the 11th and 19th day of the cycle, for a maximum of seven days | 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. |
| Pregnancy rate | During the 7th week of pregnancy | Ultrasound examination of the echo of the embryo and heart rate |
Countries
Poland
Outcome results
None listed