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

Sponsor

American University of Beirut Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT03177122

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Sterility Infertility	Drug: Myo-inositol	Phase 4

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effect of Myo-Inositol- Based Co-treatment on Oocyte Quality in Women With Polycystic Ovarian Syndrome Undergoing Assisted Reproductive Technology

Actual Study Start Date :

Mar 1, 2017

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Myo-Inositol 1g Myo-inositol per day, in combination with alpha- lipoic acid and cysteine, (Celine Tablets; Surveal Pharmaceuticals; Belgium) + 400 ug of Folic acid	Drug: Myo-inositol Patients belonging to this group will receive 1 gram of Myo-Inositol, in combination with alpha- lipoic acid and cysteine, (Celine Tablets; Surveal Pharmaceuticals; Belgium) starting 6 weeks prior to stimulation and extending until final oocyte maturation, combined with 400 µg of folic acid supplemented daily. Other Names: Celine
No Intervention: No intervention Standard care: 400 ug of Folic acid

Arm

Intervention/Treatment

Experimental: Myo-Inositol

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

Drug: Myo-inositol

Patients belonging to this group will receive 1 gram of Myo-Inositol, in combination with alpha- lipoic acid and cysteine, (Celine Tablets; Surveal Pharmaceuticals; Belgium) starting 6 weeks prior to stimulation and extending until final oocyte maturation, combined with 400 µg of folic acid supplemented daily.

Other Names:

Celine

No Intervention: No intervention

Standard care: 400 ug of Folic acid

Outcome Measures

Primary Outcome Measures

Oocyte yield [1 day from ovum pick up]
Maturation rate [1 day from ovum pick up]
Fertilization rate [16-18 hours post insemination]

Secondary Outcome Measures

Blood profile (fasting sugar and insulin levels, Testosterone, Sex Hormone-Binding protein, DHEAs, and Androstenedione) [Prior to and 6 weeks post enrollment]
Number of gonadotropin ampules [1 day from oocyte maturation trigger]
Obstetrical outcome (preterm birth) [From 24 to 36 weeks gestation]
Obstetrical outcome (low birth weight) [From 24 to 36 weeks gestation]
Obstetrical outcome (gestational diabetes) [From 24 to 36 weeks gestation]
Obstetrical outcome (preeclampsia) [From 24 to 36 weeks gestation]
Obstetrical outcome (admission to neonatal intensive care) [From 24 to 36 weeks gestation]
Number of stimulation days [1 day from oocyte maturation trigger]
Embryo quality [3 to 5 days from ovum pick up]
Miscarriage rate [7 weeks post LMP]
Ongoing pregnancy [20 weeks post LMP]
Live birth rate [24 to 42 weeks gestation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 18 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.