Polycystic Ovarian Syndrome (PCOS)
Conditions
Keywords
PCOS, Intracytoplasmic Sperm Injection
Brief summary
The goal of this clinical trial is to evaluate and compare the effectiveness of combined Myoinositol and Metformin therapy versus a combination of Pioglitazone and Metformin, and Metformin alone in infertile women with Polycystic Ovary Syndrome (PCOS) undergoing Intracytoplasmic Sperm Injection (ICSI). The main questions it aims to answer are: * Which is more suitable clinical treatment schemes for PCOS women undergoing Intracytoplasmic Sperm Injection. * Researchers will compare metformin monotherapy as the control group to the combination of metformin and Myoinositol, or Metformin combination with Pioglitazone to see which is more effective treatment approach in PCOS women undergoing ICSI. Participants will: * Take metformin, metformin and Myoinositol or Metformin and Pioglitazone every day for one month. * At 1-month post-drug therapy: Initial assessment should be conducted to evaluate the patient's response to the treatment, particularly focusing on ovarian function and any associated changes in reproductive parameters. The percentage of oocytes reaching the second meiotic division will be evaluated, indicating the readiness for fertilization. * 18 hours post-ICSI: Fertilization rates will be determined by the proportion of oocytes that successfully undergo fertilization following ICSI, reflecting the immediate success of the procedure. * 3 days post-ICSI: The cleavage rate should be determined it is the percentage of fertilized oocytes that undergo cleavage within a specified timeframe will be assessed, providing insights into embryonic development. * At 14 days post-embryo transfer: determine chemical pregnancy rate. * At weeks 4-5 of gestation, the clinical pregnancy rate is confirmed by pulsation. * Ongoing pregnancy rate is confirmed at (12 weeks of gestation) is an important time point of a gestation. * Within 3 months post-ICSI: The abortion rate should be monitored the percentage of clinical pregnancies that result in spontaneous miscarriage prior to the 20-week gestation mark will be evaluated to assess the stability of pregnancies achieved. * Incidence of Side Effects: The frequency and severity of any adverse events related to the treatment will be monitored, contributing to the overall safety profile of the interventions.
Interventions
metformin 850 mg tablets once daily for one month before ICSI
COMBINATION_PRODUCTMyoinositol and metformin
Myoinositol at a dosage of 600 mg administered twice daily and metformin 850 mg tablets once daily for one month prior to undergoing Intracytoplasmic Sperm Injection (ICSI)
COMBINATION_PRODUCTpioglitazone and metformin
A combination of pioglitazone 15 mg and metformin 850 mg tablets once daily for one month before ICSI.
Sponsors
Beni-Suef University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Age between 20 and 45years who failed to conceive for \>12 months. * BMI \< 35kg/m2 * Polycystic ovary syndrome women (PCOS) * bilateral patent tubes on hysterosalpingography/laparoscopy
Exclusion criteria
* Male factor infertility * uncontrolled hypo/hyperthyroidism couples.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fertilization rate | 3 months of follow-up | the percentage of fertilized oocytes the specified timeframe will be assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Abortion rate | 3 months | The percentage of clinical pregnancies that result in spontaneous miscarriage prior to the 20-week gestation mark will be evaluated to assess the stability of pregnancies achieved. |
Countries
Egypt
Outcome results
None listed