Myo-inositol for the Management of Poor Ovarian Responders: A Prospective Randomized Controlled Trial

NCT04273256 | Unknown Phase 2

• 1 other identifier: BIO-2018-0357
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

Brief Summary

The management of poor ovarian responders (POR) remains the most challenging in In-Vitro Fertilization (IVF). The incidence of POR ranges between 9 and 24% (Caprio F, et al, 2015). POR refers to a reduction in the quantity of primordial follicle pool in reproductive age group (Jirge, P. R., 2016, Sunkara, S. K., et al, 2014), in addition to a higher risk of implantation failure (Kailasam C, et al, 2004). To overcome this condition, fertility treatments using controlled ovarian stimulation along with IVF is needed to achieve pregnancy. Despite the use of various treatments including high dose gonadotropins, patients with POR have lower rates of pregnancy compared to patients with normal ovarian response (Oudendijk, J. F., et al, 2011). Studies now suggest a variety of regimens like the use of growth hormones, DHEA or androgens to improve the outcomes (Kyrou D, et al, 2009). The main interest of this study is the use of myo-inositol prior to IVF cycles for improvement of reproductive outcomes in poor ovarian responders.

Conditions

Poor Ovarian Response

Keywords

Myo-inositol, In-vitro fertilization, Poor Ovarian Responders, Infertility

Outcome Measures

Primary Outcomes (1)

• Retrieved oocytes

  Number of oocytes retrieved (MII), including total number, number of mature MII, and proportion of dysmorphic oocytes

  4 months

Secondary Outcomes (6)

• Cycle cancellation rate

  4 months

• Fertilization rate

  4 months

• Implantation rate

  5 months

• Clinical pregnancy rate per started treatment cycle (CPR)

  6 months

• Ongoing pregnancy per embryo transferred

  7 months

Study Arms (2)

Myo-inositol arm

EXPERIMENTAL

Patients will be supplemented with 2 grams of Myo-inositol + at least 400 μg of folic acid (received from routinely prescribed multivitamins) every day for 3 months before the IVF cycle.

Drug: Myo-inositol

Control arm

NO INTERVENTION

Patients will receive at least 400 μg of folic acid from routinely prescribed multivitamins every day for 3 months before the IVF cycle.

Interventions

Myo-inositol DRUG

patients who will be supplemented with 2 grams of Myo-inositol daily for 3 months prior to their in-vitro fertilization cycle

Also known as: Celine

Myo-inositol arm

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18-44 years at the time of interview
• POR patients defined as: AMH\<1.5 ng/nl, AFC of 7 or less, 5 oocytes or less retrieved in a previous cycle
• Patients undergoing controlled ovarian stimulation for any indication:
• Male factor
• Female factor

You may not qualify if:

• Patients with diabetes, thyroid dysfunction
• Patients with abnormal uterine cavity

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University of Beirut Medical Center

Beirut, Lebanon

RECRUITING

Related Publications (12)

• Caprio F, D'Eufemia MD, Trotta C, Campitiello MR, Ianniello R, Mele D, Colacurci N. Myo-inositol therapy for poor-responders during IVF: a prospective controlled observational trial. J Ovarian Res. 2015 Jun 12;8:37. doi: 10.1186/s13048-015-0167-x.

  PMID: 26067283 BACKGROUND

• 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: 12042283 BACKGROUND

• Croze ML, Soulage CO. Potential role and therapeutic interests of myo-inositol in metabolic diseases. Biochimie. 2013 Oct;95(10):1811-27. doi: 10.1016/j.biochi.2013.05.011. Epub 2013 Jun 10.

  PMID: 23764390 BACKGROUND

• Jirge PR. Poor ovarian reserve. J Hum Reprod Sci. 2016 Apr-Jun;9(2):63-9. doi: 10.4103/0974-1208.183514.

  PMID: 27382229 BACKGROUND

• Jiang WD, Wu P, Kuang SY, Liu Y, Jiang J, Hu K, Li SH, Tang L, Feng L, Zhou XQ. Myo-inositol prevents copper-induced oxidative damage and changes in antioxidant capacity in various organs and the enterocytes of juvenile Jian carp (Cyprinus carpio var. Jian). Aquat Toxicol. 2011 Oct;105(3-4):543-51. doi: 10.1016/j.aquatox.2011.08.012. Epub 2011 Aug 27.

  PMID: 21924699 BACKGROUND

• Kyrou D, Kolibianakis EM, Venetis CA, Papanikolaou EG, Bontis J, Tarlatzis BC. How to improve the probability of pregnancy in poor responders undergoing in vitro fertilization: a systematic review and meta-analysis. Fertil Steril. 2009 Mar;91(3):749-66. doi: 10.1016/j.fertnstert.2007.12.077. Epub 2008 Jul 21.

  PMID: 18639875 BACKGROUND

• Kailasam C, Keay SD, Wilson P, Ford WC, Jenkins JM. Defining poor ovarian response during IVF cycles, in women aged <40 years, and its relationship with treatment outcome. Hum Reprod. 2004 Jul;19(7):1544-7. doi: 10.1093/humrep/deh273. Epub 2004 May 13.

  PMID: 15142994 BACKGROUND

• Unfer V, Raffone E, Rizzo P, Buffo S. Effect of a supplementation with myo-inositol plus melatonin on oocyte quality in women who failed to conceive in previous in vitro fertilization cycles for poor oocyte quality: a prospective, longitudinal, cohort study. Gynecol Endocrinol. 2011 Nov;27(11):857-61. doi: 10.3109/09513590.2011.564687. Epub 2011 Apr 5.

  PMID: 21463230 BACKGROUND

• Unfer V, Carlomagno G, Dante G, Facchinetti F. Effects of myo-inositol in women with PCOS: a systematic review of randomized controlled trials. Gynecol Endocrinol. 2012 Jul;28(7):509-15. doi: 10.3109/09513590.2011.650660. Epub 2012 Feb 1.

  PMID: 22296306 BACKGROUND

• 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: 18462730 BACKGROUND

• Oudendijk JF, Yarde F, Eijkemans MJ, Broekmans FJ, Broer SL. The poor responder in IVF: is the prognosis always poor?: a systematic review. Hum Reprod Update. 2012 Jan-Feb;18(1):1-11. doi: 10.1093/humupd/dmr037. Epub 2011 Oct 10.

  PMID: 21987525 BACKGROUND

• Nestler JE, Jakubowicz DJ, Reamer P, Gunn RD, Allan G. Ovulatory and metabolic effects of D-chiro-inositol in the polycystic ovary syndrome. N Engl J Med. 1999 Apr 29;340(17):1314-20. doi: 10.1056/NEJM199904293401703.

  PMID: 10219066 BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

Inositol

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Officials

• Antoine Abu Mussa, MD

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antoine Abu Mussa, MD

CONTACT

01350000; aa06@aub.edu.lb

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of Obstetrics and Gynecology

Model Details: Upon consent, recruited women will be randomly allocated into either one of the study groups using a simple randomization method by computer-generated random numbers

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 18, 2020
• Study Start: February 11, 2020
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2023
• Last Updated: February 18, 2020

Record last verified: 2020-02

Locations

LE (1)