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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03177122
• Other study ID #: AmericanUBMCMYO
• Status: Recruiting
• Phase: Phase 4
• Start date: March 1, 2017
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2023
• Source: American University of Beirut Medical Center
• Contact: Johnny Awwad, MD
• Phone: 009611350000
• Email: jawwad[@]aub.edu.lb
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Sterility

Intervention

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.

Locations

Country	Name	City	State
Lebanon	American University of Beirut Medical Center	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
American University of Beirut Medical Center

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oocyte yield		1 day from ovum pick up
Primary	Maturation rate		1 day from ovum pick up
Primary	Fertilization rate		16-18 hours post insemination
Secondary	Blood profile (fasting sugar and insulin levels, Testosterone, Sex Hormone-Binding protein, DHEAs, and Androstenedione)		Prior to and 6 weeks post enrollment
Secondary	Number of gonadotropin ampules		1 day from oocyte maturation trigger
Secondary	Obstetrical outcome (preterm birth)		From 24 to 36 weeks gestation
Secondary	Obstetrical outcome (low birth weight)		From 24 to 36 weeks gestation
Secondary	Obstetrical outcome (gestational diabetes)		From 24 to 36 weeks gestation
Secondary	Obstetrical outcome (preeclampsia)		From 24 to 36 weeks gestation
Secondary	Obstetrical outcome (admission to neonatal intensive care)		From 24 to 36 weeks gestation
Secondary	Number of stimulation days		1 day from oocyte maturation trigger
Secondary	Embryo quality		3 to 5 days from ovum pick up
Secondary	Miscarriage rate		7 weeks post LMP
Secondary	Ongoing pregnancy		20 weeks post LMP
Secondary	Live birth rate		24 to 42 weeks gestation