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Polycystic Ovary SyndromePhase 2NCT02385396

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

A Phase 2 study testing Inofolic: myo-inositol and folic acid in people with Polycystic Ovary Syndrome and Infertility, run by Medical University of Lublin at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 27 to 35 years, women only
Conditions the study is for
Polycystic Ovary Syndrome, Infertility
What is being tested?
Inofolic: myo-inositol and folic acid
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
217 participants
Where
1 sitePoland
Study dates
Start not givento Oct 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 27 to 35 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • Medical University of Lublin

    Lublin, Lublin Voivodeship

Other trials in Poland

About this study

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

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).

Being tested
Inofolic: myo-inositol and folic acid
Keywords
Polycystic Ovary Syndrome, Infertility, Myo-inositol, Intracytoplasmic sperm injection
Medical subject headings
Polycystic Ovary Syndrome, Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT02385396
Study groupRoleWhat they receive
Group IPlacebo comparator60 patients diagnosed with PCOS, not myo-inositol treated undergoing ICSI
Group IIExperimental52 patients diagnosed with PCOS undergoing ICSI, taking Inofolic (myo-inositol + folic acid)
Receives: Dietary Supplement: Inofolic: myo-inositol and folic acid
Group IIIPlacebo comparator105 patients not diagnosed with PCOS undergoing ICSI, not taking myo-inositol

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Between 11th and 19th day of cycle, when the largest of the oocyte in the evaluation of ultrasound exceeded 17mm diameter,

  2. Progesterone (ng/ml) level in blood serum

    Measured: Between 11th and 19th day of cycle, when the largest of the oocyte in the evaluation of ultrasound exceeded 17mm diameter

  3. 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

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

  4. 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

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

Secondary outcomes (2)

  1. 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.

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

  2. Pregnancy rate

    Ultrasound examination of the echo of the embryo and heart rate

    Measured: During the 7th week of pregnancy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2015 (estimated)
  2. Primary completionOct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
217 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02385396
Sponsor's protocol ID
MUL024
Status last verified
Mar 2015
First submitted
12 Feb 2015
Last updated
12 Mar 2015
Results posted
No

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.

    PubMed 24591683

  • 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.

    PubMed 24909750

  • 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.

    PubMed 23059403

  • 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.

    PubMed 8706629

  • 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.

    PubMed 24526356

  • 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.

    PubMed 22274808

  • 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.

    PubMed 24505965

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

    PubMed 25054962

  • 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.

    PubMed 12042283

  • 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.

    PubMed 18462730

  • 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.

    PubMed 15206484

  • 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.

    PubMed 14711538

  • 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.

    PubMed 14688154

  • 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.

    PubMed 22748101

  • 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.

    PubMed 19729414

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Inofolic: myo-inositol and folic acid in people with Polycystic Ovary Syndrome and Infertility, run by Medical University of Lublin at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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,). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02385396, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2015.

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