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

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04273256
Enrollment
226
Registered
2020-02-18
Start date
2020-02-11
Completion date
2023-02-28
Last updated
2020-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Poor Ovarian Response

Keywords

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

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.

Detailed description

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, adjuvant 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). Inositol belongs to the vitamin B group, precursor for the synthesis of phosphatidylinositol polyphosphates (PIPs). PIPs belong to the signal transduction system involved in the regulation of different cellular functions such as signal transduction, cell morphogenesis and cytogenesis (Kutateladze TG, 2010). It is involved in cell membrane formation, lipid synthesis and cell growth (Unfer V, et al, 2012). It has been extensively studied in patients with insulin resistance, as inositol has an insulin sensitizing action (Croze ML & Soulage CO, 2013). In addition, researchers have hypothesized different mechanisms of action on different cell types especially at the level of the ovaries. An international consensus has confirmed that myo-inositol pre-treatment is able to improve the oocyte and the embryo quality via enhancing the intracellular Ca2+ oscillation with meiotic progression of germinal vesicle oocytes. Therefore, it acts on improving the oocyte maturation and embryo development (Nestler JE, et al, 1999, Papaleo E, et al, 2009). Previous studies showed that higher concentrations of myo-inositol in follicular fluid are correlated with a better oocyte quality (Chiu TT, et al, 2002). A study by Jiang demonstrated that inositol supplementation reduces oxidative stress by different agents such as increasing superoxide dismutase and catalase levels (Jiang WD, et al, 2011). In view of its effects on oocyte maturation and quality, the use of myo-inositol in women with POR is promising. However, data is still sparse whether supplementation with myo-inostiol prior to IVF cycles does improve the pregnancy outcomes. 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.

Interventions

DRUGMyo-inositol

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

Sponsors

American University of Beirut Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Retrieved oocytes4 monthsNumber of oocytes retrieved (MII), including total number, number of mature MII, and proportion of dysmorphic oocytes

Secondary

MeasureTime frameDescription
Fertilization rate4 monthsnumber of zygotes per number of oocytes inseminated
Implantation rate5 monthsnumber of intrauterine gestational sacs observed on transvaginal ultrasound divided by the number of transferred embryos
Cycle cancellation rate4 monthsnumber of cycles cancelled before reaching embryo transfer
Ongoing pregnancy per embryo transferred7 monthsnumber of viable fetuses beyond 20 weeks' gestation per number of embryos transferred
Miscarriage rates7 monthspregnancy loss prior to 12 weeks' gestation
Clinical pregnancy rate per started treatment cycle (CPR)6 monthsthe presence of a fetal heart beat on transvaginal ultrasound after 6-7 weeks of gestation

Countries

Lebanon

Contacts

Primary ContactAntoine Abu Mussa, MD
aa06@aub.edu.lb01350000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026