IVFPhase 3NCT06405204
of Myo-inositol, Melatonin and Co-enzyme q10 on Ovarian Reserve
A Phase 3 study testing Myoinositol, Co-Enzyme Q10 and Melatonin in people with IVF, run by Beni-Suef University at 1 site in Egypt.
Trial summary
To evaluate the role of Myo-inositol, melatonin and co-enzyme Q10 on ovarian reserve parameters and ICSI outcome in poor ovarian responder Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- IVF
- What is being tested?
- Myoinositol, Co-Enzyme Q10 and Melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jun 2024to 30 Dec 2024
- Phase
- Phase 3
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Infertile women who have one of the criteria of poor ovarian response as follows;
- Antral follicle count less than 7
- Anti-Mullerian hormone level Less than 1.2 ng/ml
Who cannot join
- Any endocrine or metabolic disorder such as hyperprolactinemia, diabetes and thyroid dysfunction
- Any pelvic pathology such as hydrosalpinx, uterine anomaly.
- Any male factor infertility such as Oligo-Astheno-Teratozoospermia (OAT) or azoospermia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Myo-inositol, Melatonin and Co-enzyme q10 on Ovarian Reserve Parameters and Intra-cytoplasmic Sperm Injection Outcomes in Patient With Poor Ovarian Reserve: an Open Label Randomized Clinical Trial
To evaluate the role of Myo-inositol, melatonin and co-enzyme Q10 on ovarian reserve parameters and ICSI outcome in poor ovarian responder
Read the detailed description
Each patient will be subjected to:
Full history taking. Systematic clinical examination to assess the general condition, body mass index (BMI) and local pelvic physical findings and AFC by trans-vaginal ultrasound on day 2 to day 3 of menstruation. Routine labs as CBC, liver \& kidney functions to exclude general disease as a contraindication for induction or pregnancy.
Blood sample will be obtained for assessment of basal serum levels of FSH, LH, E2 on days 2- 3 of the cycle. PRL, AMH and TSH Ovarian Stimulation The patients will begin injections of recombinant FSH (rFSH, Gonal-F; Merck- Serono, Italy) from day 2-3 of menstruation, with daily dose of 300-450 IU adjusted according to individual conditions on the basis of the antral follicle count (AFC),hormonal profile, age, body mass index (BMI), and previous ovarian response, according to the standard operating procedures of the center. . For pituitary suppression, the patients will receive GnRH antagonist Cetrorelix (CETROTIDE 0.25Mg/d, Merck Serono, Germany) 0.25 mg/day subcutaneously from day 6 of induction until trigger day. The serum LH, estradiol levels as well as number and size of follicles will be monitored every two days, starting from stimulation day 6 until the day of hCG injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyoinositolDrug
Also called femtonex, Viocyst
an enzymatic isoform of inositol and belongs to the vitamin B complex family
Co-Enzyme Q10Drug
Also called Co Q
a lipid-soluble quinone, acting as an effective antioxidant,
MelatoninDrug
an indoleamine with low molecular weight that is synthesized by different cells and organs in the body. More importantly, melatonin is an outstanding antioxidant
Folic acidDrug
Also called folicap
control
| Study group | Role | What they receive |
|---|---|---|
| myo-inositol | Experimental | myo-inositol (1gm capsules bd ) plus folic acid 400 mcg per day Receives: Drug: Myoinositol |
| melatonin | Experimental | melatonin 1 capsule every night orally before going to bed plus folic acid 400mcg per day Receives: Drug: Melatonin |
| co-enzyme Q10 | Experimental | co-enzyme Q10 100mg per day plus folic acid 400 mcg per day Receives: Drug: Co-Enzyme Q10 |
| control group. | Placebo comparator | will receive folic acid 400 mcg per day Receives: Drug: Folic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy
serum HCG positive
Measured: 1 month of induction for ICSI trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start30 Jun 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (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 IVFStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Abdallah Mohamed Salem, Beni-Suef University
- Investigators
- Sara A Salem, MD, Principal investigator, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06405204
- Sponsor's protocol ID
- Co-enzyme q10
- Status last verified
- May 2024
- First submitted
- 4 May 2024
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdelrahman MA, Gamal M, Salem SA, Ibrahim ARN, Rabea H. Coenzyme Q10 Impact on Ovarian Reserve Measures and the Intra-Cytoplasmic Sperm Injection (ICSI) Outcomes in Women with Poor Ovarian Response: A Randomized Controlled Study. Drug Des Devel Ther. 2026 Mar 2;20:583321. doi: 10.2147/DDDT.S583321. eCollection 2026.
PubMed 41800295
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Myo-inositol, Melatonin and Co-enzyme q10 on Ovarian Reserve Parameters and Intra-cytoplasmic Sperm Injection Outcomes in Patient With Poor Ovarian Reserve: an Open Label Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06405204
- Acronym / sponsor ID
- Co-enzyme q10
- Conditions
- IVF
- Keywords
- Myo-inositol, Melatonin, Co-enzyme q10, ovarian reserve
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 30 Jun 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 8 May 2024 (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.
To evaluate the role of Myo-inositol, melatonin and co-enzyme Q10 on ovarian reserve parameters and ICSI outcome in poor ovarian responder
Detailed description
Each patient will be subjected to:
Full history taking. Systematic clinical examination to assess the general condition, body mass index (BMI) and local pelvic physical findings and AFC by trans-vaginal ultrasound on day 2 to day 3 of menstruation. Routine labs as CBC, liver \& kidney functions to exclude general disease as a contraindication for induction or pregnancy.
Blood sample will be obtained for assessment of basal serum levels of FSH, LH, E2 on days 2- 3 of the cycle. PRL, AMH and TSH Ovarian Stimulation The patients will begin injections of recombinant FSH (rFSH, Gonal-F; Merck- Serono, Italy) from day 2-3 of menstruation, with daily dose of 300-450 IU adjusted according to individual conditions on the basis of the antral follicle count (AFC),hormonal profile, age, body mass index (BMI), and previous ovarian response, according to the standard operating procedures of the center. . For pituitary suppression, the patients will receive GnRH antagonist Cetrorelix (CETROTIDE 0.25Mg/d, Merck Serono, Germany) 0.25 mg/day subcutaneously from day 6 of induction until trigger day. The serum LH, estradiol levels as well as number and size of follicles will be monitored every two days, starting from stimulation day 6 until the day of hCG injection
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| myo-inositol | Experimental | Drug: Myoinositolmyo-inositol (1gm capsules bd ) plus folic acid 400 mcg per day |
| melatonin | Experimental | Drug: Melatoninmelatonin 1 capsule every night orally before going to bed plus folic acid 400mcg per day |
| co-enzyme Q10 | Experimental | Drug: Co-Enzyme Q10co-enzyme Q10 100mg per day plus folic acid 400 mcg per day |
| control group. | Placebo comparator | Drug: Folic acidwill receive folic acid 400 mcg per day |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Infertile women who have one of the criteria of poor ovarian response as follows;
Key exclusion criteria (3 listed)
- Any endocrine or metabolic disorder such as hyperprolactinemia, diabetes and thyroid dysfunction
- Any pelvic pathology such as hydrosalpinx, uterine anomaly.
- Any male factor infertility such as Oligo-Astheno-Teratozoospermia (OAT) or azoospermia
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 |
|---|---|---|
| MyoinositolAlso: femtonex, Viocystan enzymatic isoform of inositol and belongs to the vitamin B complex family | Drug | myo-inositol |
| Co-Enzyme Q10Also: Co Qa lipid-soluble quinone, acting as an effective antioxidant, | Drug | co-enzyme Q10 |
| Melatoninan indoleamine with low molecular weight that is synthesized by different cells and organs in the body. More importantly, melatonin is an outstanding antioxidant | Drug | melatonin |
| Folic acidAlso: folicapcontrol | Drug | control group. |
Primary outcome
pregnancy
Time frame: 1 month of induction for ICSI trial
serum HCG positive
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Derived from this study: PubMed 41800295Abdelrahman MA, Gamal M, Salem SA, Ibrahim ARN, Rabea H. Coenzyme Q10 Impact on Ovarian Reserve Measures and the Intra-Cytoplasmic Sperm Injection (ICSI) Outcomes in Women with Poor Ovarian Response: A Randomized Controlled Study. Drug Des Devel Ther. 2026 Mar 2;20:583321. doi: 10.2147/DDDT.S583321. eCollection 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.
Sara A Salem, MD principal investigator
Beni-Suef University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Myoinositol, Co-Enzyme Q10 and Melatonin in people with IVF, 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 8 May 2024. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara S Sara Salem, MD (+201272842226, sara_abdallah100@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pregnancy (time frame: 1 month of induction for ICSI trial). 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 NCT06405204, 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 8 May 2024.