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

March 11, 2015 updated by: Artur Wdowiak, Medical University of Lublin

Evaluation Concerning the Influence of 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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

217

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Lublin, Poland
        • Medical University of Lublin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

27 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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,
Between 11th and 19th day of cycle, when the largest of the oocyte in the evaluation of ultrasound exceeded 17mm diameter,
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
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)
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
On puncture day or on collection day of oocytes, in practice, between 11th and 19th day of cycle
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
On puncture day or on collection day of oocytes, in practice, between 11th and 19th day of cycle

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the moment of puncture, between the 11th and 19th day of the cycle, for a maximum of seven days
Pregnancy rate
Time Frame: During the 7th week of pregnancy
Ultrasound examination of the echo of the embryo and heart rate
During the 7th week of pregnancy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Lublin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

February 12, 2015

First Submitted That Met QC Criteria

March 5, 2015

First Posted (Estimate)

March 11, 2015

Study Record Updates

Last Update Posted (Estimate)

March 12, 2015

Last Update Submitted That Met QC Criteria

March 11, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUL024

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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