Polycystic Ovarian Syndrome (PCOS)NCT07604779
Enhancing PCOS Management for Better Outcomes of Intracytoplasmic Sperm Injection
A study testing Metformin monotherapy, Myoinositol and metformin and pioglitazone and metformin in people with Polycystic Ovarian Syndrome (PCOS), run by Beni-Suef University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Polycystic Ovarian Syndrome (PCOS)
- What is being tested?
- Metformin monotherapy, Myoinositol and metformin and pioglitazone and metformin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 17 May 2026to 3 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Male factor infertility
- uncontrolled hypo/hyperthyroidism couples.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Beni-Suef University Hospital
Banī Suwayf, Beni Suweif Governorate, 62521
About this study
Official title: Advances in Polycystic Ovarian Syndrome PCOS Management for Enhancing the Outcome 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.
Read more
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)
- Being tested
- Metformin monotherapy, Myoinositol and metformin, pioglitazone and metformin
- Keywords
- PCOS, Intracytoplasmic Sperm Injection
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin monotherapyDrug
metformin 850 mg tablets once daily for one month before ICSI
Myoinositol and metforminCombination 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 metforminCombination product
A combination of pioglitazone 15 mg and metformin 850 mg tablets once daily for one month before ICSI.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | Group I (n=50 PCOS patients) will be as the controlled group and receive metformin monotherapy. Receives: 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) Receives: 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 Receives: Combination Product: pioglitazone and metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fertilization rate
the percentage of fertilized oocytes the specified timeframe will be assessed.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start17 May 2026
- Primary completion3 Dec 2026 (estimated)
- Study completion3 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovarian Syndrome (PCOS)Studies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasnaa Osama, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07604779
- Sponsor's protocol ID
- FMBSUREC/01082026/Mohamed
- Status last verified
- May 2026
- First submitted
- 17 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advances in Polycystic Ovarian Syndrome PCOS Management for Enhancing the Outcome of Intracytoplasmic Sperm Injection
- ClinicalTrials.gov ID
- NCT07604779
- Acronym / sponsor ID
- FMBSUREC/01082026/Mohamed
- Conditions
- Polycystic Ovarian Syndrome (PCOS)
- Keywords
- PCOS, Intracytoplasmic Sperm Injection
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 17 May 2026 (actual)
- Primary completion
- 3 Dec 2026 (estimated)
- Study completion
- 3 Mar 2027 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Drug: Metformin monotherapyGroup I (n=50 PCOS patients) will be as the controlled group and receive metformin monotherapy. |
| Group II | Experimental | Combination Product: Myoinositol and metforminGroup 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) |
| Group III | Experimental | Combination Product: pioglitazone and metforminGroup 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 |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Male factor infertility
- uncontrolled hypo/hyperthyroidism couples.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin monotherapymetformin 850 mg tablets once daily for one month before ICSI | Drug | Group I |
| Myoinositol and metforminMyoinositol 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 | Group II |
| pioglitazone and metforminA combination of pioglitazone 15 mg and metformin 850 mg tablets once daily for one month before ICSI. | Combination product | Group III |
Primary outcome
Fertilization rate
Time frame: 3 months of follow-up
the percentage of fertilized oocytes the specified timeframe will be assessed.
1 secondary outcome
Abortion rate
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Background: PubMed 38374053Zhao 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.
- Individual participant dataSharing planned: Undecided
Related trials for Polycystic Ovarian Syndrome (PCOS)
Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin monotherapy, Myoinositol and metformin and pioglitazone and metformin in people with Polycystic Ovarian Syndrome (PCOS), run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fertilization rate (time frame: 3 months of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07604779, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.