Myo-inositol Therapy on the Dynamics of Embryo Development in Patients Suffering From PCOS Undergoing ICSI Treatment
Study Details
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| 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 |
Outcome Measures
Primary Outcome Measures
- 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,]
- 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
- 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
Secondary Outcome Measures
- 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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical University of Lublin | Lublin | Poland |
Sponsors and Collaborators
- Medical University of Lublin
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Aanesen A, Westerbotn M. Prospective study of a Swedish infertile cohort 2005-08: population characteristics, treatments and pregnancy rates. Fam Pract. 2014 Jun;31(3):290-7. doi: 10.1093/fampra/cmu003. Epub 2014 Mar 3.
- Chiu TT, Rogers MS, Law EL, Briton-Jones CM, Cheung LP, Haines CJ. Follicular fluid and serum concentrations of myo-inositol in patients undergoing IVF: relationship with oocyte quality. Hum Reprod. 2002 Jun;17(6):1591-6.
- Combelles CM, Holick EA, Racowsky C. Release of superoxide dismutase-1 by day 3 embryos of varying quality and implantation potential. J Assist Reprod Genet. 2012 Apr;29(4):305-11. doi: 10.1007/s10815-012-9711-4. Epub 2012 Jan 25.
- Gerli S, Mignosa M, Di Renzo GC. Effects of inositol on ovarian function and metabolic factors in women with PCOS: a randomized double blind placebo-controlled trial. Eur Rev Med Pharmacol Sci. 2003 Nov-Dec;7(6):151-9.
- Gougeon A. Regulation of ovarian follicular development in primates: facts and hypotheses. Endocr Rev. 1996 Apr;17(2):121-55. Review.
- Huang JY, Rosenwaks Z. In vitro fertilisation treatment and factors affecting success. Best Pract Res Clin Obstet Gynaecol. 2012 Dec;26(6):777-88. doi: 10.1016/j.bpobgyn.2012.08.017. Epub 2012 Oct 9.
- Jakimiuk AJ, Szamatowicz J. [The role of inositol deficiency in the etiology of polycystic ovary syndrome disorders]. Ginekol Pol. 2014 Jan;85(1):54-7. Review. Polish.
- Křepelka P. [Myo-inositol in the treatment of polycystic ovary syndrome]. Ceska Gynekol. 2014 Jun;79(3):242-6. Review. Czech.
- Papaleo E, Unfer V, Baillargeon JP, Fusi F, Occhi F, De Santis L. Myo-inositol may improve oocyte quality in intracytoplasmic sperm injection cycles. A prospective, controlled, randomized trial. Fertil Steril. 2009 May;91(5):1750-4. doi: 10.1016/j.fertnstert.2008.01.088. Epub 2008 May 7.
- Rotterdam ESHRE/ASRM-Sponsored PCOS consensus workshop group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome (PCOS). Hum Reprod. 2004 Jan;19(1):41-7. Review.
- Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome. Fertil Steril. 2004 Jan;81(1):19-25.
- Seleem AK, El Refaeey AA, Shaalan D, Sherbiny Y, Badawy A. Superoxide dismutase in polycystic ovary syndrome patients undergoing intracytoplasmic sperm injection. J Assist Reprod Genet. 2014 Apr;31(4):499-504. doi: 10.1007/s10815-014-0190-7. Epub 2014 Feb 14.
- Shorakae S, Boyle J, Teede H. Polycystic ovary syndrome: a common hormonal condition with major metabolic sequelae that physicians should know about. Intern Med J. 2014 Aug;44(8):720-6. doi: 10.1111/imj.12495. Review.
- MUL024