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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02385396
• Other study ID #: MUL024
• Status: Completed
• Phase: Phase 2
• First received: February 12, 2015
• Last updated: March 11, 2015

Study information

• Verified date: March 2015
• Source: Medical University of Lublin
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 27 Years to 35 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility
• Polycystic Ovary Syndrome

Intervention

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

Locations

Country	Name	City	State
Poland	Medical University of Lublin	Lublin

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Lublin

Country where clinical trial is conducted

Poland, 

References & Publications (27)

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Bausenwein J, Serke H, Eberle K, Hirrlinger J, Jogschies P, Hmeidan FA, Blumenauer V, Spanel-Borowski K. Elevated levels of oxidized low-density lipoprotein and of catalase activity in follicular fluid of obese women. Mol Hum Reprod. 2010 Feb;16(2):117-24 — View Citation

Bidzinska-Speichert B, Lenarcik A, Tworowska-Bardzinska U, Slezak R, Bednarek-Tupikowska G, Milewicz A, Krepula K. Pro12Ala PPAR gamma2 gene polymorphism in women with polycystic ovary syndrome. Ginekol Pol. 2011 Jun;82(6):426-9. — View Citation

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Carbone MC, Tatone C, Delle Monache S, Marci R, Caserta D, Colonna R, Amicarelli F. Antioxidant enzymatic defences in human follicular fluid: characterization and age-dependent changes. Mol Hum Reprod. 2003 Nov;9(11):639-43. — View Citation

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. — View Citation

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. — View Citation

Gawecka JE, Marh J, Ortega M, Yamauchi Y, Ward MA, Ward WS. Mouse zygotes respond to severe sperm DNA damage by delaying paternal DNA replication and embryonic development. PLoS One. 2013;8(2):e56385. doi: 10.1371/journal.pone.0056385. Epub 2013 Feb 19. — View Citation

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. — View Citation

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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. — View Citation

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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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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,	No
Primary	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	No
Primary	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	On puncture day or on collection day of oocytes, in practice, between 11th and 19th day of cycle	No
Primary	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	On puncture day or on collection day of oocytes, in practice, between 11th and 19th day of cycle	No
Secondary	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.	From the moment of puncture, between the 11th and 19th day of the cycle, for a maximum of seven days	No
Secondary	Pregnancy rate	Ultrasound examination of the echo of the embryo and heart rate	During the 7th week of pregnancy	No