Polycystic Ovary SyndromePhase 4NCT01540747
Role of Melatonin Supplementation in Follicular Fluid of in Vitro Fertilization (IVF) Patients With Polycystic Ovarian Syndrome
A Phase 4 study testing Myo-inositol + folic acid + melatonin and Myo-inositol + folic acid in people with Polycystic Ovary Syndrome, run by AGUNCO Obstetrics and Gynecology Centre at 1 site in Italy.
Trial summary
To evaluate the effects of melatonin supplementation on the main in vitro fertilization (IVF) outcomes during ovarian stimulation in patients with Polycystic ovarian syndrome (PCOS). Read more about this study
- Who is it for?
- Ages 27 to 38 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Myo-inositol + folic acid + melatonin and Myo-inositol + folic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteItaly
- Study dates
- Start not givento not given
- Phase
- Phase 4
- 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 27 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- diagnosis of PCOS
- irregular menstrual cycle (> than 28-30 days)
- normal uterine cavity
- body mass index of 20 to 26 Kg/m2
- first IVF treatment
Who cannot join
- presence of tubal, uterine, genetics and male causes of infertility
- diagnosis of cancer
- hormonal treatment in the last six months
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the effects of melatonin supplementation on the main in vitro fertilization (IVF) outcomes during ovarian stimulation in patients with Polycystic ovarian syndrome (PCOS).
Read the detailed description
Polycystic ovarian syndrome (PCOS) is a common endocrine disorder that causes infertility due to anovulation in women of reproductive age. Anovulation and also decreased oocyte and embryo quality may be cause of infertility in women with PCOS. Furthermore, the reactive oxygen species (ROS) induce oxidative stress which may be responsible for poor oocyte quality. The ROS generation from mononuclear cells is elevated in women with PCOS and a significant increment of lipid peroxidation products in women with PCOS has been reported.
Melatonin is a documented powerful free radical scavenger and a broad spectrum antioxidant. It has been observed that a non-PCOS group co-treated with inositol, folic acid, and melatonin (Inofolic Plus by LO.LI.Pharma) results in a significantly greater mean number of mature oocytes, and a lower mean number of immature oocytes in patients with low oocyte quality history when compared to treatment only with inositol and folic acid (Inofolic by LO.LI.Pharma).
The aim of the study is to evaluate the possible effects of melatonin supplementation on the main IVF outcomes during ovarian stimulation of patients with PCOS.
From July 2009 to December 2011, 358 patients with PCOS (Rotterdam criteria) were enrolled in this prospective randomized controlled trial.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Myo-inositol + folic acid + melatonin, Myo-inositol + folic acid
- Keywords
- intrafollicular melatonin, PCOS, embryos quality, oocytes quality
- 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.
Myo-inositol + folic acid + melatoninDietary supplement
Myo-inositol (2000mg)+ folic acid (200 mcg)+ melatonin(3 mg)
Myo-inositol + folic acidDietary supplement
Myo-inositol (2000mg) + folic acid (200 mcg)
| Study group | Role | What they receive |
|---|---|---|
| Inofolic plus | Experimental | 178 patients Receives: Dietary Supplement: Myo-inositol + folic acid + melatonin |
| Inofolic | Active comparator | 180 patients Receives: Dietary Supplement: Myo-inositol + folic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of mature oocytes
embryo quality
Pregnancy rate
Implantation rate
Secondary outcomes (6)
Total dose of FSH administered
Number of days of stimulation
Serum estradiol levels
Endometrial thickness
Endometrial thickness on the day of human chorionic gonadotropin (hCG) administration
Cancellation rate
Incidence of moderate or severe ovaric hyperstimulation syndrome (OHSS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2012 (estimated)
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.
- 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 4
Sponsor and investigators
- Lead sponsor
- AGUNCO Obstetrics and Gynecology Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01540747
- Sponsor's protocol ID
- Mel_FF
- Status last verified
- Jan 2009
- First submitted
- 17 Feb 2012
- Last updated
- 29 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Melatonin Supplementation in Follicular Fluid of in Vitro Fertilization (IVF) Patients With Polycystic Ovarian Syndrome
- ClinicalTrials.gov ID
- NCT01540747
- Acronym / sponsor ID
- Mel_FF
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- intrafollicular melatonin, PCOS, embryos quality, oocytes quality
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- AGUNCO Obstetrics and Gynecology CentreUniversity, hospital or other
- First posted
- 29 Feb 2012 (estimated)
- 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 effects of melatonin supplementation on the main in vitro fertilization (IVF) outcomes during ovarian stimulation in patients with Polycystic ovarian syndrome (PCOS).
Detailed description
Polycystic ovarian syndrome (PCOS) is a common endocrine disorder that causes infertility due to anovulation in women of reproductive age. Anovulation and also decreased oocyte and embryo quality may be cause of infertility in women with PCOS. Furthermore, the reactive oxygen species (ROS) induce oxidative stress which may be responsible for poor oocyte quality. The ROS generation from mononuclear cells is elevated in women with PCOS and a significant increment of lipid peroxidation products in women with PCOS has been reported.
Melatonin is a documented powerful free radical scavenger and a broad spectrum antioxidant. It has been observed that a non-PCOS group co-treated with inositol, folic acid, and melatonin (Inofolic Plus by LO.LI.Pharma) results in a significantly greater mean number of mature oocytes, and a lower mean number of immature oocytes in patients with low oocyte quality history when compared to treatment only with inositol and folic acid (Inofolic by LO.LI.Pharma).
The aim of the study is to evaluate the possible effects of melatonin supplementation on the main IVF outcomes during ovarian stimulation of patients with PCOS.
From July 2009 to December 2011, 358 patients with PCOS (Rotterdam criteria) were enrolled in this prospective randomized controlled trial.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inofolic plus | Experimental | Dietary Supplement: Myo-inositol + folic acid + melatonin178 patients |
| Inofolic | Active comparator | Dietary Supplement: Myo-inositol + folic acid180 patients |
Who may qualify
- Ages
- 27 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- diagnosis of PCOS
- irregular menstrual cycle (> than 28-30 days)
- normal uterine cavity
- body mass index of 20 to 26 Kg/m2
- first IVF treatment
Key exclusion criteria (3 listed)
- presence of tubal, uterine, genetics and male causes of infertility
- diagnosis of cancer
- hormonal treatment in the last six months
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-inositol + folic acid + melatoninMyo-inositol (2000mg)+ folic acid (200 mcg)+ melatonin(3 mg) | Dietary supplement | Inofolic plus |
| Myo-inositol + folic acidMyo-inositol (2000mg) + folic acid (200 mcg) | Dietary supplement | Inofolic |
Primary outcome
Number of mature oocytes
embryo quality
Pregnancy rate
Implantation rate
6 secondary outcomes
Total dose of FSH administered
Number of days of stimulation
Serum estradiol levels
Endometrial thickness
Cancellation rate
Incidence of moderate or severe ovaric hyperstimulation syndrome (OHSS)
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 29 Feb 2012.
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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 Phase 4 study testing Myo-inositol + folic acid + melatonin and Myo-inositol + folic acid in people with Polycystic Ovary Syndrome, run by AGUNCO Obstetrics and Gynecology Centre at 1 site in Italy.
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 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: finished, as of the sponsor's last update on 29 Feb 2012. 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 Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of mature oocytes. The study lists 4 primary outcomes in all. 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 29 Feb 2012.