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

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ClinicalTrials.gov Identifier: NCT02385396
Recruitment Status : Completed
First Posted : March 11, 2015
Last Update Posted : March 12, 2015
Sponsor:
Information provided by (Responsible Party):
Artur Wdowiak, 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).

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Infertility Dietary Supplement: Inofolic: myo-inositol and folic acid Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 217 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: 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
Actual Primary Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Group I
60 patients diagnosed with PCOS, not myo-inositol treated undergoing ICSI
Experimental: Group II
52 patients diagnosed with PCOS undergoing ICSI, taking Inofolic (myo-inositol + folic acid)
Dietary Supplement: Inofolic: myo-inositol and folic acid
4000 mg of myo-inositol and 0,4 mg of folic acid for 3 months preceding the ICSI procedure

Placebo Comparator: Group III
105 patients not diagnosed with PCOS undergoing ICSI, not taking myo-inositol



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   27 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02385396


Locations
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Poland
Medical University of Lublin
Lublin, Poland
Sponsors and Collaborators
Medical University of Lublin
Publications of Results:

Other Publications:

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Responsible Party: Artur Wdowiak, MD PhD, Medical University of Lublin
ClinicalTrials.gov Identifier: NCT02385396    
Other Study ID Numbers: MUL024
First Posted: March 11, 2015    Key Record Dates
Last Update Posted: March 12, 2015
Last Verified: March 2015
Keywords provided by Artur Wdowiak, Medical University of Lublin:
Polycystic Ovary Syndrome
Infertility
Myo-inositol
Intracytoplasmic sperm injection
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Infertility
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Folic Acid
Inositol
Hematinics
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs