Enhancing PCOS Management for Better Outcomes of Intracytoplasmic Sperm Injection

NCT07604779 | Active Not Recruiting

• 1 other identifier: FMBSUREC/01082026/Mohamed
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovarian Syndrome (PCOS)

Keywords

PCOS; Intracytoplasmic Sperm Injection

Outcome Measures

Primary Outcomes (1)

• Fertilization rate

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

  3 months of follow-up

Secondary Outcomes (1)

• Abortion rate

  3 months

Study Arms (3)

Group I

ACTIVE COMPARATOR

Group I (n=50 PCOS patients) will be as the controlled group and receive metformin monotherapy.

Drug: Metformin monotherapy

Group II

EXPERIMENTAL

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)

Combination Product: Myoinositol and metformin

Group III

EXPERIMENTAL

Group III (n=50 PCOS patients) will receive a combination of pioglitazone 15 mg and metformin 850 mg tablets once daily for one month before ICSI

Combination Product: pioglitazone and metformin

Interventions

Metformin monotherapy DRUG

metformin 850 mg tablets once daily for one month before ICSI

Group I

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)

Group II

pioglitazone and metformin COMBINATION_PRODUCT

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

Group III

Eligibility Criteria

• Age: 20 Years - 45 Years
• Gender Eligibility Details: female patients diagnosed with PCOS are eligible for participation in the study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Male factor infertility
• uncontrolled hypo/hyperthyroidism couples.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni-Suef University Hospital

Banī Suwayf, Beni Suweif Governorate, 62521, Egypt

Location

Related Publications (1)

• Zhao 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 BACKGROUND

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Inositol; Metformin; Pioglitazone

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Biguanides; Guanidines; Amidines; Thiazolidinediones; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of Clinical Pharmacy

Study Record Dates

• First Submitted: May 17, 2026
• First Posted: May 22, 2026
• Study Start: May 17, 2026
• Primary Completion (Estimated): December 3, 2026
• Study Completion (Estimated): March 3, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

EG (1)