Effect of Myo-Inositol-in combination with alpha-lipoic acid and cysteine (Celine) based co-treatment on Oocyte Quality in Women with Polycystic Ovarian Syndrome Undergoing Assisted Reproductive Technology
Phase 4
- Conditions
- Nutritional, Metabolic, EndocrineFertility-female
- Registration Number
- PACTR202401759325189
- Lead Sponsor
- Jehan Elfarjani
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 100
Inclusion Criteria
Women aged 20-40 years at the time of enrollment
- diagnosed with PCOS (according to the Rotterdam criteria, represented by oligomenorrhea, hyperandrogenism or hyperandrogenemia, and typical ovarian features on ultrasound),
- and undergoing in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) treatment.
- Normal uterine cavity as assessed by hysteroscopy or hysterosalpingography and normal prolactin and thyroid-stimulating hormone levels were required.
Exclusion Criteria
Women with male factor infertility, such as azoospermia
Women with other medical conditions causing ovulatory dysfunction, such as hyperprolactinemia, hypothyroidism, or adrenal hyperplasia.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome measures were oocyte parameters, including preovulatory follicle count, which reflects the number of preovulatory follicles >17mm in size, total number of oocytes retrieved, which typically ranges from 6 to 15; oocyte quality, defined by the number of MII oocytes retrieved; and the number and quality of embryos transferred, based on the number of morphologically Grade 1 embryos.
- Secondary Outcome Measures
Name Time Method Secondary outcomes included duration of ovarian stimulation, number of gonadotropin vials used reflecting total gonadotropin dose, and pregnancy based on ultrasound.