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NCT Number: NCT07779850

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

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).

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Glucose Metabolism Disorders Gonadal Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Neoplasms Nutritional and Metabolic Diseases Ovarian Cysts Ovarian Diseases Ovarian Hyperstimulation Syndrome Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kafr-Elsheikh University Hospital

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: At oocyte retrieval, after approximately 3 months of assigned supplementation

    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.

Secondary outcomes

  1. Number of Mature Metaphase II (MII) Oocytes

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

    Number of mature metaphase II (MII) oocytes obtained from each participant at oocyte retrieval.

  2. Number of Fertilized Oocytes

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

    Number of injected oocytes that achieved fertilization following in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI).

  3. Embryo Quality

    Time frame: 44 to 48 hours after fertilization

    Embryo quality was assessed according to European Society of Human Reproduction and Embryology (ESHRE) morphological criteria based on blastomere regularity, degree of fragmentation, and multinucleation. Embryos were classified into Grades 1, 2, and 3.

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study title

Impact of Inositol on Controlled Ovarian Stimulation & ICSI Outcome of Women With PCOS: Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 21, 2026
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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