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

Medical University of Lublin

Status and phase: Completed; Phase 2

Conditions: Infertility; Polycystic Ovary Syndrome

Treatments: Dietary Supplement: Inofolic: myo-inositol and folic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT02385396

MUL024

Details and patient eligibility

About

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).

Enrollment: 217 patients

Sex: Female

Ages: 27 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

217 participants in 3 patient groups, including a placebo group

Group I

Placebo Comparator group

Description:

60 patients diagnosed with PCOS, not myo-inositol treated undergoing ICSI

Group II

Experimental group

Description:

52 patients diagnosed with PCOS undergoing ICSI, taking Inofolic (myo-inositol + folic acid)

Treatment:

Dietary Supplement: Inofolic: myo-inositol and folic acid

Group III

Placebo Comparator group

Description:

105 patients not diagnosed with PCOS undergoing ICSI, not taking myo-inositol