Clinical trial · Interventional
Enhancing PCOS Management for Better Outcomes of Intracytoplasmic Sperm Injection
Advances in Polycystic Ovarian Syndrome PCOS Management for Enhancing the Outcome of Intracytoplasmic Sperm Injection
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovarian Syndrome (PCOS) | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin monotherapy | Drug | — | UNRESOLVED |
| Myoinositol and metformin | Combination Product | — | UNRESOLVED |
| pioglitazone and metformin | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Group I
- description
- Group I (n=50 PCOS patients) will be as the controlled group and receive metformin monotherapy.
- interventionNames
- Drug: Metformin monotherapy
- type
- EXPERIMENTAL
- label
- Group II
- description
- Group II (n=50 PCOS patinets) will receive combination of 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)
- interventionNames
- Combination Product: Myoinositol and metformin
- type
- EXPERIMENTAL
- label
- Group III
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDZhao H, Zhang J, Xing C, Cheng X, He B. Metformin versus metformin plus pioglitazone on gonadal and metabolic profiles in normal-weight women with polycystic ovary syndrome: a single-center, open-labeled prospective randomized controlled trial. J Ovarian Res. 2024 Feb 19;17(1):42. doi: 10.1186/s13048-024-01367-7. PMID 38374053