Polycystic Ovary SyndromeNCT07779850
Myo-Inositol for Ovarian Stimulation and ICSI Outcomes in Women With PCOS
A study testing Myo-Inositol and Folic Acid in people with Polycystic Ovary Syndrome, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
Polycystic ovary syndrome (PCOS) is a common endocrine disorder that may affect ovarian function, insulin sensitivity, and fertility. Myo-inositol has been proposed as an insulin-sensitizing supplement that may improve metabolic and reproductive outcomes in women with PCOS. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Myo-Inositol and Folic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2024to 15 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female participants aged 18 to 40 years.
- Diagnosis of polycystic ovary syndrome (PCOS) according to the Rotterdam criteria.
- Normal thyroid hormone levels.
- Normal prolactin levels.
- Candidates for in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI).
Who cannot join
- Previous ovarian surgery.
- History of endometrioma.
- History of endocrine disease, including congenital adrenal hyperplasia or diabetes mellitus.
- Smoking.
- Known allergy to myo-inositol.
- Current use of oral contraceptive pills.
- Receipt of hormonal medications within the 3 months before study enrollment.
- Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Kafr-Elsheikh University Hospital
Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33511
About this study
Official title: Impact of Inositol on Controlled Ovarian Stimulation & ICSI Outcome of Women With PCOS: Randomized Controlled Trial
Polycystic ovary syndrome (PCOS) is a common endocrine disorder that may affect ovarian function, insulin sensitivity, and fertility. Myo-inositol has been proposed as an insulin-sensitizing supplement that may improve metabolic and reproductive outcomes in women with PCOS.
This randomized, double-blind clinical trial evaluated the effect of myo-inositol supplementation on controlled ovarian stimulation and assisted reproductive technology (ART) outcomes in women with PCOS undergoing in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI). A total of 88 participants were randomly assigned to two parallel groups. The intervention group received myo-inositol combined with folic acid, while the control group received folic acid alone for 3 months before the ART cycle and until the day of oocyte retrieval.
The study assessed whether myo-inositol could improve metabolic and hormonal parameters, ovarian response to stimulation, oocyte and embryo quality, and pregnancy outcomes, while also evaluating ovarian hyperstimulation syndrome (OHSS).
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Myo-Inositol, Folic Acid
- Keywords
- Myo-Inositol, Assisted Reproductive Technology, Controlled Ovarian Stimulation, In Vitro Fertilization, Intracytoplasmic Sperm Injection, Oocyte Quality, Embryo Quality, Insulin Resistance, Ovarian Hyperstimulation Syndrome, Chemical Pregnancy, Clinical Pregnancy
- Medical subject headings
- Polycystic Ovary Syndrome, Insulin Resistance, Ovarian Hyperstimulation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myo-InositolDietary supplement
Myo-inositol was administered as 600 mg capsules in combination with folic acid 0.24 mg twice daily. Supplementation was started 3 months before the assisted reproductive technology (ART) cycle and continued until the day of oocyte retrieval.
Folic AcidDietary supplement
Folic acid 0.24 mg was administered for 3 months before initiation of the assisted reproductive technology (ART) cycle and continued until the day of oocyte retrieval.
| Study group | Role | What they receive |
|---|---|---|
| Myo-Inositol Plus Folic Acid | Experimental | Participants received myo-inositol 600 mg combined with folic acid 0.24 mg twice daily for 3 months before starting the assisted reproductive technology (ART) cycle and continued treatment until the day of oocyte retrieval. Receives: Dietary Supplement: Myo-Inositol |
| Folic Acid Control | Active comparator | Participants received folic acid 0.24 mg for 3 months before starting the assisted reproductive technology (ART) cycle and continued treatment until the day of oocyte retrieval. Receives: Dietary Supplement: Folic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Number of Immature and Degenerated Oocytes (GV-DEG)
Mean number of immature and degenerated oocytes, including germinal vesicle and degenerated (GV-DEG) oocytes, obtained from each participant following controlled ovarian stimulation. This outcome was used as the primary endpoint for the sample size calculation.
Measured: At oocyte retrieval, after approximately 3 months of assigned supplementation
Secondary outcomes (3)
Number of Mature Metaphase II (MII) Oocytes
Number of mature metaphase II (MII) oocytes obtained from each participant at oocyte retrieval.
Measured: At oocyte retrieval, approximately 3 months after initiation of assigned supplementation
Number of Fertilized Oocytes
Number of injected oocytes that achieved fertilization following in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI).
Measured: At fertilization assessment, approximately 16-18 hours after IVF/ICSI and within 1 day after oocyte retrieval
Embryo Quality
Embryo quality was assessed according to European Society of Human Reproduction and Embryology (ESHRE) morphological criteria based on blastomere regularity, degree of fragmentation, and multinucleation. Embryos were classified into Grades 1, 2, and 3.
Measured: 44 to 48 hours after fertilization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start15 May 2024
- Primary completion15 Feb 2025
- Study completion15 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- Model description
- Participants with polycystic ovary syndrome (PCOS) undergoing in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI) were randomly assigned in parallel to receive either myo-inositol plus folic acid or folic acid alone for 3 months before the assisted reproductive technology (ART) cycle and until the day of oocyte retrieval.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elzahraa Ismail Ragheb Gouda, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07779850
- Sponsor's protocol ID
- KFSIRB200-100
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Inositol on Controlled Ovarian Stimulation & ICSI Outcome of Women With PCOS: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07779850
- Acronym / sponsor ID
- KFSIRB200-100
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Myo-Inositol, Assisted Reproductive Technology, Controlled Ovarian Stimulation, In Vitro Fertilization, Intracytoplasmic Sperm Injection, Oocyte Quality, Embryo Quality, Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 15 Feb 2025 (actual)
- Study completion
- 15 Feb 2025 (actual)
- First posted
- 21 Aug 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.
Polycystic ovary syndrome (PCOS) is a common endocrine disorder that may affect ovarian function, insulin sensitivity, and fertility. Myo-inositol has been proposed as an insulin-sensitizing supplement that may improve metabolic and reproductive outcomes in women with PCOS.
This randomized, double-blind clinical trial evaluated the effect of myo-inositol supplementation on controlled ovarian stimulation and assisted reproductive technology (ART) outcomes in women with PCOS undergoing in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI). A total of 88 participants were randomly assigned to two parallel groups. The intervention group received myo-inositol combined with folic acid, while the control group received folic acid alone for 3 months before the ART cycle and until the day of oocyte retrieval.
The study assessed whether myo-inositol could improve metabolic and hormonal parameters, ovarian response to stimulation, oocyte and embryo quality, and pregnancy outcomes, while also evaluating ovarian hyperstimulation syndrome (OHSS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants with polycystic ovary syndrome (PCOS) undergoing in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI) were randomly assigned in parallel to receive either myo-inositol plus folic acid or folic acid alone for 3 months before the assisted reproductive technology (ART) cycle and until the day of oocyte retrieval.
| Arm | Type | Receives |
|---|---|---|
| Myo-Inositol Plus Folic Acid | Experimental | Dietary Supplement: Myo-InositolParticipants received myo-inositol 600 mg combined with folic acid 0.24 mg twice daily for 3 months before starting the assisted reproductive technology (ART) cycle and continued treatment until the day of oocyte retrieval. |
| Folic Acid Control | Active comparator | Dietary Supplement: Folic AcidParticipants received folic acid 0.24 mg for 3 months before starting the assisted reproductive technology (ART) cycle and continued treatment until the day of oocyte retrieval. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female participants aged 18 to 40 years.
- Diagnosis of polycystic ovary syndrome (PCOS) according to the Rotterdam criteria.
- Normal thyroid hormone levels.
- Normal prolactin levels.
- Candidates for in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI).
Key exclusion criteria (8 listed)
- Previous ovarian surgery.
- History of endometrioma.
- History of endocrine disease, including congenital adrenal hyperplasia or diabetes mellitus.
- Smoking.
- Known allergy to myo-inositol.
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 |
|---|---|---|
| Myo-InositolMyo-inositol was administered as 600 mg capsules in combination with folic acid 0.24 mg twice daily. Supplementation was started 3 months before the assisted reproductive technology (ART) cycle and continued until the day of oocyte retrieval. | Dietary supplement | Myo-Inositol Plus Folic Acid |
| Folic AcidFolic acid 0.24 mg was administered for 3 months before initiation of the assisted reproductive technology (ART) cycle and continued until the day of oocyte retrieval. | Dietary supplement | Folic Acid Control |
Primary outcome
Mean Number of Immature and Degenerated Oocytes (GV-DEG)
Time frame: At oocyte retrieval, after approximately 3 months of assigned supplementation
Mean number of immature and degenerated oocytes, including germinal vesicle and degenerated (GV-DEG) oocytes, obtained from each participant following controlled ovarian stimulation. This outcome was used as the primary endpoint for the sample size calculation.
3 secondary outcomes
Number of Mature Metaphase II (MII) Oocytes
Time frame: At oocyte retrieval, approximately 3 months after initiation of assigned supplementation
Number of Fertilized Oocytes
Time frame: At fertilization assessment, approximately 16-18 hours after IVF/ICSI and within 1 day after oocyte retrieval
Embryo Quality
Time frame: 44 to 48 hours after fertilization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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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 Myo-Inositol and Folic Acid in people with Polycystic Ovary Syndrome, run by Kafrelsheikh 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 21 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean Number of Immature and Degenerated Oocytes (GV-DEG) (time frame: At oocyte retrieval, after approximately 3 months of assigned supplementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2026.