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NCT Number: NCT07604779

Enhancing PCOS Management for Better Outcomes of Intracytoplasmic Sperm Injection

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Beni-Suef University Hospital

Banī Suwayf, Beni Suweif Governorate, 62521, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Metformin monotherapy

Drug

metformin 850 mg tablets once daily for one month before ICSI

Myoinositol and metformin

Combination Product

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)

pioglitazone and metformin

Combination Product

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

Primary outcomes

  1. Fertilization rate

    Time frame: 3 months of follow-up

    the percentage of fertilized oocytes the specified timeframe will be assessed.

Secondary outcomes

  1. Abortion rate

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

Advances in Polycystic Ovarian Syndrome PCOS Management for Enhancing the Outcome of Intracytoplasmic Sperm Injection

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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