NCT03177122

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2017

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 6, 2017

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

July 20, 2023

Status Verified

July 1, 2023

Enrollment Period

6.8 years

First QC Date

May 25, 2017

Last Update Submit

July 19, 2023

Conditions

SterilityInfertility

Keywords

Polycystic Ovary SyndromeMyo-InositolAssisted Reproductive Technologyoocyte performancepregnancy

Outcome Measures

Primary Outcomes (3)

  • Oocyte yield

    1 day from ovum pick up

  • Maturation rate

    1 day from ovum pick up

  • Fertilization rate

    16-18 hours post insemination

Secondary Outcomes (12)

  • 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

  • +7 more secondary outcomes

Study Arms (2)

Myo-Inositol

EXPERIMENTAL

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

No intervention

NO INTERVENTION

Standard care: 400 ug of Folic acid

Interventions

Myo-inositolDRUG

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.

Also known as: Celine
Myo-Inositol

Eligibility Criteria

Age18 Years - 18 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American University of Beirut Medical Center

Beirut, Lebanon

RECRUITING

Related Publications (1)

  • Shukla R, Chadha M, Adya A, Yadav A, Singh N, Chauhan RS, Ahmad A, Tiwari RK. Ongoing Clinical Trials for Polycystic Ovarian Syndrome (PCOS) Afflicted Infertility in Women: A Narrative Review. Rev Recent Clin Trials. 2025;20(2):113-123. doi: 10.2174/0115748871325070241008101355.

    PMID: 39421989DERIVED

MeSH Terms

Conditions

InfertilityPolycystic Ovary Syndrome

Interventions

Inositol

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesOvarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Study Officials

  • Johnny Awwad, MD

    American University of Beirut Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Johnny Awwad, MD

CONTACT

009611350000jawwad@aub.edu.lb

Layal Hamdar, MS

CONTACT

009611350000lh72@aub.edu.lb

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Obstetrics and Gynecology

Study Record Dates

First Submitted

May 25, 2017

First Posted

June 6, 2017

Study Start

March 1, 2017

Primary Completion

December 1, 2023

Study Completion

December 31, 2023

Last Updated

July 20, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

LE(1)