Polycystic Ovary Syndrome
Conditions
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
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).
Interventions
DIETARY_SUPPLEMENTMyo-Inositol
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.
DIETARY_SUPPLEMENTFolic Acid
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.
Sponsors
Kafrelsheikh University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Participants and investigators were blinded to treatment allocation throughout the intervention period.
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Number of Immature and Degenerated Oocytes (GV-DEG) | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Mature Metaphase II (MII) Oocytes | 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. |
| Number of Fertilized Oocytes | 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). |
| Embryo Quality | 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. |
Countries
Egypt
Outcome results
None listed