Myo-Inositol- Based Co-treatment in Women With PCOS Undergoing Assisted Reproductive Technology

American University of Beirut Medical Center

Status and phase: Enrolling; Phase 4

Conditions: Infertility; Sterility

Treatments: Drug: Myo-inositol

Study type: Interventional

Funder types: Other

Identifiers

NCT03177122

AmericanUBMCMYO

Details and patient eligibility

About

This is a prospective comparative randomized controlled study investigating the effect of Myo-Inositol-based co-treatment on oocyte quality measures in women with PCOS.

Full description

Polycystic Ovary Syndrome is the most common cause of chronic anovulation in women. Women with PCOS undergoing IVF are at an increased risk for developing both multiple gestation and ovarian hyperstimulation syndrome (OHSS). Since insulin resistance and hyperinsulinemia have been implicated in the pathophysiology of the disorder, the administration of metformin before or during an IVF cycle has been practiced for years in an attempt to improve follicular parameters necessary for reproductive success. Recently, a growing body of evidence has implicated alternative insulin sensitizing drugs, namely Myo-Inositol, in improving various manifestations of the disorder in this women population. Little has been done to evaluate the effect of Myo-Inositol co-treatment on the reproductive performance of PCOS women undergoing Assisted Reproductive Technologies (ART). In this prospective comparative randomized controlled study, women will be randomized into two groups: Women in the control group will receive folic acid daily. Women in the study group will receive Myo-Inositol, in combination with alpha- lipoic acid and cysteine, per day plus folic acid supplemented daily along with ovarian stimulation.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 18-40 years at the time of enrollment.
• Women diagnosed with PCOS according to the Rotterdam criteria indicated by oligoamenorrhea (six or fewer menstrual cycles during a period of 1 year), hyperandrogenism (hirsutism, acne, or alopecia) or hyperandrogenemia (elevated levels of total or free T) and typical features of ovaries on ultrasound scan.
• Planned IVF/ICSI treatment.
• Normal uterine cavity (as assessed by hysteroscopy or HSG).
• Normal hormonal investigation: TSH and PRL.

Exclusion criteria

• Azoospermia.
• Other medical conditions causing ovulatory disorders, such as hyperprolactinemia, hypothyroidism, or adrenal hyperplasia.
• Hypersensitivity to Myo-Inositol or its derivatives.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Myo-Inositol

Experimental group

Description:

1g Myo-inositol per day, in combination with alpha- lipoic acid and cysteine, (Celine Tablets; Surveal Pharmaceuticals; Belgium) + 400 ug of Folic acid

Treatment:

Drug: Myo-inositol

No intervention

No Intervention group

Description:

Standard care: 400 ug of Folic acid