CClinicalTrials.gg
Sign In
Active, not recruitingNCT07604779Updated May 22, 2026

Enhancing PCOS Management for Better Outcomes of Intracytoplasmic Sperm Injection

An interventional study of Metformin monotherapy and Myoinositol and metformin in Polycystic Ovarian Syndrome (PCOS), sponsored by Beni-Suef University. Active, not recruiting at 1 site in Egypt. Open to female participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by Beni-Suef University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
Female
01

Study 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.
02

Conditions studied

  • Polycystic Ovarian Syndrome (PCOS)

Keywords

  • PCOS
  • Intracytoplasmic Sperm Injection
03

In context

Polycystic Ovary Syndrome

944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.

This study's planned enrollment of 150 is above the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

Beni-Suef University is the lead sponsor of 333 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Female
Accepts 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

Exclusion Criteria:

  • Male factor infertility
  • uncontrolled hypo/hyperthyroidism couples.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Active comparator
    Group I

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

    Drug: Metformin monotherapy

  • Experimental
    Group II

    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

  • Experimental
    Group III

    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

  • DrugMetformin monotherapy

    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.

06

What researchers measure

Primary outcomes

  1. Fertilization rate

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

    Time frame: 3 months of follow-up

Secondary outcomes

  1. Abortion rate

    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.

    Time frame: 3 months

07

Study locations

1 site
  • Beni-Suef University Hospital
    Banī Suwayf, Beni Suweif Governorate 62521, Egypt
08

References and documents

Publications

  • 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. PubMed 38374053 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07604779
Lead sponsor
Beni-Suef University
Responsible party
Hasnaa Osama (Associate professor of Clinical Pharmacy, Beni-Suef University) — Principal investigator
First posted
May 22, 2026
Start date
May 17, 2026
Primary completion
Dec 3, 2026 (estimated)
Completion
Mar 3, 2027 (estimated)
Last update
May 22, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Polycystic Ovary Syndrome→

Other studies from this sponsor

Beni-Suef University

Start the discussion