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

Phase 2

Completed

• Conditions: Polycystic Ovary Syndrome; Infertility

• Registration Number: NCT02385396
• Lead Sponsor: Medical University of Lublin

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).

Detailed Description

Not available

Study Timeline

• Primary Completion: 2014-10
• Study First Submitted: 2015-02-12
• Status Verified: 2015-03
• Study First Submitted QC: 2015-03-05
• Study First Posted: 2015-03-11
• Last Update Submitted: 2015-03-11
• Last Update Posted: 2015-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 217

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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,
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
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Medical University of Lublin; 🇵🇱 Lublin, Poland