NCT02385396

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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
217

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2015

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 11, 2015

Completed
Last Updated

March 12, 2015

Status Verified

March 1, 2015

First QC Date

February 12, 2015

Last Update Submit

March 11, 2015

Conditions

Polycystic Ovary SyndromeInfertility

Keywords

Polycystic Ovary SyndromeInfertilityMyo-inositolIntracytoplasmic sperm injection

Outcome Measures

Primary Outcomes (4)

  • 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)

    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)

    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 Outcomes (2)

  • 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

  • Pregnancy rate

    During the 7th week of pregnancy

Study Arms (3)

Group I

PLACEBO COMPARATOR

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

Group II

EXPERIMENTAL

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

Dietary Supplement: Inofolic: myo-inositol and folic acid

Group III

PLACEBO COMPARATOR

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

Interventions

Inofolic: myo-inositol and folic acidDIETARY_SUPPLEMENT

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

Group II

Eligibility Criteria

Age27 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • Severe endometriosis BMI \<17 and \>30 Metabolic diseases Lowered ovarian reserve

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Lublin

Lublin, Lublin Voivodeship, Poland

Location

Related Publications (27)

  • 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.

    PMID: 24591683BACKGROUND

  • 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.

    PMID: 24909750BACKGROUND

  • 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.

    PMID: 23059403BACKGROUND

  • Gougeon A. Regulation of ovarian follicular development in primates: facts and hypotheses. Endocr Rev. 1996 Apr;17(2):121-55. doi: 10.1210/edrv-17-2-121. No abstract available.

    PMID: 8706629BACKGROUND

  • 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.

    PMID: 24526356BACKGROUND

  • 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.

    PMID: 22274808BACKGROUND

  • 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. doi: 10.17772/gp/1691. Polish.

    PMID: 24505965BACKGROUND

  • Krepelka P. [Myo-inositol in the treatment of polycystic ovary syndrome]. Ceska Gynekol. 2014 Jun;79(3):242-6. Czech.

    PMID: 25054962BACKGROUND

  • 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. doi: 10.1093/humrep/17.6.1591.

    PMID: 12042283BACKGROUND

  • Papaleo E, Unfer V, Baillargeon JP, Fusi F, Occhi F, De Santis L. RETRACTED: Myo-inositol may improve oocyte quality in intracytoplasmic sperm injection cycles. A prospective, controlled, randomized trial. Fertil Steril. 2009 May;91(5):1750-1754. doi: 10.1016/j.fertnstert.2008.01.088. Epub 2008 May 7.

    PMID: 18462730BACKGROUND

  • 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.

    PMID: 15206484BACKGROUND

  • 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. doi: 10.1016/j.fertnstert.2003.10.004.

    PMID: 14711538BACKGROUND

  • 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. doi: 10.1093/humrep/deh098.

    PMID: 14688154BACKGROUND

  • Agarwal A, Aponte-Mellado A, Premkumar BJ, Shaman A, Gupta S. The effects of oxidative stress on female reproduction: a review. Reprod Biol Endocrinol. 2012 Jun 29;10:49. doi: 10.1186/1477-7827-10-49.

    PMID: 22748101RESULT

  • 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. doi: 10.1093/molehr/gap078. Epub 2009 Sep 3.

    PMID: 19729414RESULT

  • Nel-Themaat L, Nagy ZP. A review of the promises and pitfalls of oocyte and embryo metabolomics. Placenta. 2011 Sep;32 Suppl 3:S257-63. doi: 10.1016/j.placenta.2011.05.011. Epub 2011 Jun 23.

    PMID: 21703683RESULT

  • Kurus M, Karakaya C, Karalok MH, To G, Johnson J. The control of oocyte survival by intrinsic and extrinsic factors. Adv Exp Med Biol. 2013;761:7-18. doi: 10.1007/978-1-4614-8214-7_2.

    PMID: 24097378RESULT

  • Ashwood-Smith MJ, Edwards RG. DNA repair by oocytes. Mol Hum Reprod. 1996 Jan;2(1):46-51. doi: 10.1093/molehr/2.1.46.

    PMID: 9238657RESULT

  • Inbar-Feigenberg M, Choufani S, Butcher DT, Roifman M, Weksberg R. Basic concepts of epigenetics. Fertil Steril. 2013 Mar 1;99(3):607-15. doi: 10.1016/j.fertnstert.2013.01.117. Epub 2013 Jan 26.

    PMID: 23357459RESULT

  • Whitelaw N, Bhattacharya S, Hoad G, Horgan GW, Hamilton M, Haggarty P. Epigenetic status in the offspring of spontaneous and assisted conception. Hum Reprod. 2014 Jul;29(7):1452-8. doi: 10.1093/humrep/deu094. Epub 2014 May 8.

    PMID: 24812310RESULT

  • Azzarello A, Hoest T, Mikkelsen AL. The impact of pronuclei morphology and dynamicity on live birth outcome after time-lapse culture. Hum Reprod. 2012 Sep;27(9):2649-57. doi: 10.1093/humrep/des210. Epub 2012 Jun 26.

    PMID: 22740496RESULT

  • Kirkegaard K, Kesmodel US, Hindkjaer JJ, Ingerslev HJ. Time-lapse parameters as predictors of blastocyst development and pregnancy outcome in embryos from good prognosis patients: a prospective cohort study. Hum Reprod. 2013 Oct;28(10):2643-51. doi: 10.1093/humrep/det300. Epub 2013 Jul 30.

    PMID: 23900207RESULT

  • 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.

    PMID: 23431372RESULT

  • Campbell A, Fishel S, Bowman N, Duffy S, Sedler M, Hickman CF. Modelling a risk classification of aneuploidy in human embryos using non-invasive morphokinetics. Reprod Biomed Online. 2013 May;26(5):477-85. doi: 10.1016/j.rbmo.2013.02.006. Epub 2013 Feb 19.

    PMID: 23518033RESULT

  • 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.

    PMID: 21853931RESULT

  • 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. doi: 10.1093/molehr/gag090.

    PMID: 14561807RESULT

  • Munoz M, Cruz M, Humaidan P, Garrido N, Perez-Cano I, Meseguer M. Dose of recombinant FSH and oestradiol concentration on day of HCG affect embryo development kinetics. Reprod Biomed Online. 2012 Oct;25(4):382-9. doi: 10.1016/j.rbmo.2012.06.016. Epub 2012 Jul 4.

    PMID: 22877941RESULT

MeSH Terms

Conditions

Polycystic Ovary SyndromeInfertility

Interventions

Folic Acid

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

February 12, 2015

First Posted

March 11, 2015

Primary Completion

October 1, 2014

Last Updated

March 12, 2015

Record last verified: 2015-03

Locations

PL(1)