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

Primary Purpose

Polycystic Ovary Syndrome, Infertility

Status

Completed

Phase

Phase 2

Locations

Poland

Study Type

Interventional

Intervention

Inofolic: myo-inositol and folic acid

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Polycystic Ovary Syndrome, Infertility, Myo-inositol, Intracytoplasmic sperm injection

Eligibility Criteria

27 Years - 35 Years (Adult)FemaleDoes not accept 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

Sites / Locations

Medical University of Lublin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Group I

Group II

Group III

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Progesterone (ng/ml) level in blood serum

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

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

Catalase activity level in follicular fluid (mIU/mg)

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

Period of blastocyst and embryo development

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

Ultrasound examination of the echo of the embryo and heart rate

Full Information

NCT ID

NCT02385396

First Posted

February 12, 2015

Last Updated

March 11, 2015

Sponsor

Medical University of Lublin

1. Study Identification

Unique Protocol Identification Number

NCT02385396

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

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Primary Completion Date

October 2014 (Actual)

Study Completion Date

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3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Lublin

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polycystic Ovary Syndrome, Infertility

Keywords

Polycystic Ovary Syndrome, Infertility, Myo-inositol, Intracytoplasmic sperm injection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Enrollment

217 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group I

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Group II

Arm Type

Experimental

Arm Description

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

Arm Title

Group III

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Inofolic: myo-inositol and folic acid

Intervention Description

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

Primary Outcome Measure Information:

Title

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,

Title

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

Title

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

Description

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

Time Frame

On puncture day or on collection day of oocytes, in practice, between 11th and 19th day of cycle

Title

Catalase activity level in follicular fluid (mIU/mg)

Description

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

Time Frame

On puncture day or on collection day of oocytes, in practice, between 11th and 19th day of cycle

Secondary Outcome Measure Information:

Title

Period of blastocyst and embryo development

Description

Time Frame

From the moment of puncture, between the 11th and 19th day of the cycle, for a maximum of seven days

Title

Pregnancy rate

Description

Ultrasound examination of the echo of the embryo and heart rate

Time Frame

During the 7th week of pregnancy

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

27 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Medical University of Lublin

City

Lublin

Country

Poland

12. IPD Sharing Statement

Citations:

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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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