Enhancing PCOS Management for Better Outcomes of Intracytoplasmic Sperm Injection

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.

Conditions

• Polycystic Ovarian Syndrome (PCOS)

Interventions

DRUG

Metformin monotherapy

metformin 850 mg tablets once daily for one month before ICSI

COMBINATION_PRODUCT

Myoinositol 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_PRODUCT

pioglitazone and metformin

A combination of pioglitazone 15 mg and metformin 850 mg tablets once daily for one month before ICSI.

Sponsors & Collaborators

• Beni-Suef University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-17

Primary Completion

2026-12-03

Completion

2027-03-03

Countries

• Egypt

Study Locations