Clinical trial · Interventional
Myo-inositol Therapy on the Dynamics of Embryo Development in Patients Suffering From PCOS Undergoing ICSI Treatment
Evaluation Concerning the Influence of Myo-inositol Therapy on the Dynamics of Embryo Development in Patients Suffering From PCOS Undergoing ICSI Treatment
NCT02385396CI-TRIAL-00017123completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Infertility | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Inofolic: myo-inositol and folic acid | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- PLACEBO_COMPARATOR
- label
- Group I
- description
- 60 patients diagnosed with PCOS, not myo-inositol treated undergoing ICSI
- type
- EXPERIMENTAL
- label
- Group II
- description
- 52 patients diagnosed with PCOS undergoing ICSI, taking Inofolic (myo-inositol + folic acid)
- interventionNames
- Dietary Supplement: Inofolic: myo-inositol and folic acid
- type
- PLACEBO_COMPARATOR
- label
- Group III
- description
- 105 patients not diagnosed with PCOS undergoing ICSI, not taking myo-inositol
Primary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 27 Years
- Maximum age
- 35 Years
Show eligibility criteria text
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
References
Publications (27)
- BACKGROUNDAanesen 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 24591683
- BACKGROUNDShorakae 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 24909750
- BACKGROUNDHuang 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 23059403
- BACKGROUNDGougeon 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 8706629
- BACKGROUNDSeleem 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 24526356
- BACKGROUNDCombelles 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 22274808
- BACKGROUNDJakimiuk 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 24505965
- Krepelka P. [Myo-inositol in the treatment of polycystic ovary syndrome]. Ceska Gynekol. 2014 Jun;79(3):242-6. Czech.