Myo-Inositol for Ovarian Stimulation and ICSI Outcomes in Women With PCOS

NCT07779850 | Completed

• 1 other identifier: KFSIRB200-100
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

Polycystic ovary syndrome (PCOS) is a common endocrine disorder that may affect ovarian function, insulin sensitivity, and fertility. Myo-inositol has been proposed as an insulin-sensitizing supplement that may improve metabolic and reproductive outcomes in women with PCOS. This randomized, double-blind clinical trial evaluated the effect of myo-inositol supplementation on controlled ovarian stimulation and assisted reproductive technology (ART) outcomes in women with PCOS undergoing in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI). A total of 88 participants were randomly assigned to two parallel groups. The intervention group received myo-inositol combined with folic acid, while the control group received folic acid alone for 3 months before the ART cycle and until the day of oocyte retrieval. The study assessed whether myo-inositol could improve metabolic and hormonal parameters, ovarian response to stimulation, oocyte and embryo quality, and pregnancy outcomes, while also evaluating ovarian hyperstimulation syndrome (OHSS).

Conditions

Polycystic Ovary Syndrome

Keywords

Myo-Inositol; Assisted Reproductive Technology; Controlled Ovarian Stimulation; In Vitro Fertilization; Intracytoplasmic Sperm Injection; Oocyte Quality; Embryo Quality; Insulin Resistance; Ovarian Hyperstimulation Syndrome; Chemical Pregnancy; Clinical Pregnancy

Outcome Measures

Primary Outcomes (1)

• Mean Number of Immature and Degenerated Oocytes (GV-DEG)

  Mean number of immature and degenerated oocytes, including germinal vesicle and degenerated (GV-DEG) oocytes, obtained from each participant following controlled ovarian stimulation. This outcome was used as the primary endpoint for the sample size calculation.

  At oocyte retrieval, after approximately 3 months of assigned supplementation

Secondary Outcomes (3)

• Number of Mature Metaphase II (MII) Oocytes

  At oocyte retrieval, approximately 3 months after initiation of assigned supplementation

• Number of Fertilized Oocytes

  At fertilization assessment, approximately 16-18 hours after IVF/ICSI and within 1 day after oocyte retrieval

• Embryo Quality

  44 to 48 hours after fertilization

Study Arms (2)

Myo-Inositol Plus Folic Acid

EXPERIMENTAL

Participants received myo-inositol 600 mg combined with folic acid 0.24 mg twice daily for 3 months before starting the assisted reproductive technology (ART) cycle and continued treatment until the day of oocyte retrieval.

Dietary Supplement: Myo-Inositol

Folic Acid Control

ACTIVE COMPARATOR

Participants received folic acid 0.24 mg for 3 months before starting the assisted reproductive technology (ART) cycle and continued treatment until the day of oocyte retrieval.

Dietary Supplement: Folic Acid

Interventions

Myo-Inositol DIETARY_SUPPLEMENT

Myo-inositol was administered as 600 mg capsules in combination with folic acid 0.24 mg twice daily. Supplementation was started 3 months before the assisted reproductive technology (ART) cycle and continued until the day of oocyte retrieval.

Myo-Inositol Plus Folic Acid

Folic Acid DIETARY_SUPPLEMENT

Folic acid 0.24 mg was administered for 3 months before initiation of the assisted reproductive technology (ART) cycle and continued until the day of oocyte retrieval.

Folic Acid Control

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female participants aged 18 to 40 years.
• Diagnosis of polycystic ovary syndrome (PCOS) according to the Rotterdam criteria.
• Normal thyroid hormone levels.
• Normal prolactin levels.
• Candidates for in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI).

You may not qualify if:

• Previous ovarian surgery.
• History of endometrioma.
• History of endocrine disease, including congenital adrenal hyperplasia or diabetes mellitus.
• Smoking.
• Known allergy to myo-inositol.
• Current use of oral contraceptive pills.
• Receipt of hormonal medications within the 3 months before study enrollment.
• Refusal to participate in the study.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafr-Elsheikh University Hospital

Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33511, Egypt

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Insulin Resistance; Ovarian Hyperstimulation Syndrome

Interventions

Inositol; Folic Acid

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants and investigators were blinded to treatment allocation throughout the intervention period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Obstetrics and Gynecology

Model Details: Participants with polycystic ovary syndrome (PCOS) undergoing in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI) were randomly assigned in parallel to receive either myo-inositol plus folic acid or folic acid alone for 3 months before the assisted reproductive technology (ART) cycle and until the day of oocyte retrieval.

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: August 21, 2026
• Study Start: May 15, 2024
• Primary Completion: February 15, 2025
• Study Completion: February 15, 2025
• Last Updated: August 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)