Clinical trial NCT02385396: Myo-inositol Therapy on the Dynamics of Embryo Development in Patients Suffering From PCOS Undergoing ICSI Treatment
Official title: Evaluation Concerning the Influence of Myo-inositol Therapy on the Dynamics of Embryo Development in Patients Suffering From PCOS Undergoing ICSI Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Polycystic Ovary Syndrome
Infertility
Keywords: Polycystic Ovary Syndrome
Infertility
Myo-inositol
Intracytoplasmic sperm injection
Lead sponsor: Medical University of Lublin
Sponsor class: OTHER
First posted: 2015-03-11
Enrollment: 217
Sex: FEMALE
Minimum age (years): 27
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Oestradiol (E2) level in blood serum (pg/ml)
timeFrame: Between 11th and 19th day of cycle, when the largest of the oocyte in the evaluation of ultrasound exceeded 17mm diameter,
measure: Progesterone (ng/ml) level in blood serum
timeFrame: Between 11th and 19th day of cycle, when the largest of the oocyte in the evaluation of ultrasound exceeded 17mm diameter
measure: Superoxide dismutase (SOD) activity level in follicular fluid (mIU/mg)
timeFrame: On puncture day or on collection day of oocytes, in practice, between 11th and 19th day of cycle
measure: Catalase activity level in follicular fluid (mIU/mg)
timeFrame: On puncture day or on collection day of oocytes, in practice, between 11th and 19th day of cycle
Secondary outcomes:
measure: Period of blastocyst and embryo development
timeFrame: From the moment of puncture, between the 11th and 19th day of the cycle, for a maximum of seven days
measure: Pregnancy rate
timeFrame: During the 7th week of pregnancy
Other outcomes:
Locations:
city: Lublin
country: Poland
facility: Medical University of Lublin
Study officials:
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