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Completed

NCT Number: NCT02385396

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

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).

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Infertility Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

27 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Medical University of Lublin

Lublin, Lublin Voivodeship, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inofolic: myo-inositol and folic acid

Dietary Supplement

4000 mg of myo-inositol and 0,4 mg of folic acid for 3 months preceding the ICSI procedure

Primary outcomes

  1. Oestradiol (E2) level in blood serum (pg/ml)

    Time frame: Between 11th and 19th day of cycle, when the largest of the oocyte in the evaluation of ultrasound exceeded 17mm diameter,

  2. Progesterone (ng/ml) level in blood serum

    Time frame: Between 11th and 19th day of cycle, when the largest of the oocyte in the evaluation of ultrasound exceeded 17mm diameter

  3. Superoxide dismutase (SOD) activity level in follicular fluid (mIU/mg)

    Time frame: 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

  4. Catalase activity level in follicular fluid (mIU/mg)

    Time frame: 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 outcomes

  1. Period of blastocyst and embryo development

    Time frame: 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.

  2. Pregnancy rate

    Time frame: During the 7th week of pregnancy

    Ultrasound examination of the echo of the embryo and heart rate

Sponsors and collaborators

Lead sponsor

Medical University of Lublin

Other

Registry information

Official study title

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

Important dates

Primary completion
2014
First posted
Mar 11, 2015
Registry last updated
Mar 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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