InfertilityPhase 4NCT01267604
Ovarian Stimulation: Inositol and Melatonin
A Phase 4 study testing Recombinant FSH (rFSH) and rFSH + Inositol + Melatonin in people with Infertility, run by AGUNCO Obstetrics and Gynecology Centre at 2 sites in Italy.
Trial summary
An efficient protocol of ovarian stimulation is a key part of assisted reproductive technology. In order to obtain the highest oocyte retrieval with no adverse effects, numerous studies have evaluated the efficiency of the clinical approaches currently available. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Recombinant FSH (rFSH) and rFSH + Inositol + Melatonin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesItaly
- Study dates
- Dec 2010to Dec 2013
- 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 18 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female age 18-39 years
- BMI 18-30 kg/m2,
- Fewer than 3 prior oocyte retrievals,
- No fertility Problems
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
University of Modena and Reggio Emilia
Reggio Emilia, 42100
Research Center for Reproductive Medicine Villa Mafalda
Roma, 00199
About this study
Official title: Improving Oocyte Retrieval Using a Combined Therapy of Recombinant Follicle Stimulating Hormone (rFSH) and Inositol and Melatonin
An efficient protocol of ovarian stimulation is a key part of assisted reproductive technology. In order to obtain the highest oocyte retrieval with no adverse effects, numerous studies have evaluated the efficiency of the clinical approaches currently available.
Recent studies have shown that two natural compounds, such as inositol and melatonin, play an important role in oocyte maturation and quality. Therefore, the present study aims at investigating whether inositol and melatonin are able to improve the number of oocytes obtained after ovarian stimulation with Recombinant Follicle Stimulating Hormone (rFSH).
Read more
To this purpose, a randomized double-blind trial will be established where 150 healthy women in reproductive age undergoing to assistant reproductive technology (ART) because of male infertility will be divided in two groups. Group A will be treated with 225IU rFSH alone, group B will be treated with 225IU rFSH, 4g inositol and 3mg melatonin.
As primary outcome of the study, oocyte quality, total number of oocytes retrieved, clinical pregnancy rate and live birth rate will be evaluated in group A vs. group B.
- Conditions
- Infertility
- Being tested
- Recombinant FSH (rFSH), rFSH + Inositol + Melatonin
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant FSH (rFSH)Drug
225IU
rFSH + Inositol + MelatoninDietary supplement
225IU rFSH, 4g Inositol, 3mg Melatonin
| Study group | Role | What they receive |
|---|---|---|
| Recombinant FSH | Active comparator | 225IU rFSH Receives: Drug: Recombinant FSH (rFSH) |
| Recombinant FSH Inositol Melatonin | Experimental | 225IU rFSH, 4g Inositol and 3mg Melatonin Receives: Dietary Supplement: rFSH + Inositol + Melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total oocyte number
Measured: 2 weeks after pharmacological treatment
Number of clinical pregnancies
Measured: 6 weeks after embryo transfer
Live birth rate
Measured: 10 months after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AGUNCO Obstetrics and Gynecology Centre
- Sponsor type
- University, hospital or other
- Collaborators
- University of Modena and Reggio Emilia, Research Center for Reproductive Medicine Villa Mafalda
- Responsible party
- Sponsor
- Investigators
- Vittorio Unfer, MD, Study director, AGUNCO Obstetrics and Gynecology CentreGianfranco Carlomagno, PhD, Principal investigator, AGUNCO Obstetrics and Gynecology CentreLa Sala Giovanni Battista, MD, Principal investigator, University of Modena and Reggio EmiliaFranco Lisi, MD, Principal investigator, Research Center for Reproductive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01267604
- Sponsor's protocol ID
- rFSH-INOPLUS
- Status last verified
- Jul 2023
- First submitted
- 23 Dec 2010
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Rizzo P, Raffone E, Benedetto V. Effect of the treatment with myo-inositol plus folic acid plus melatonin in comparison with a treatment with myo-inositol plus folic acid on oocyte quality and pregnancy outcome in IVF cycles. A prospective, clinical trial. Eur Rev Med Pharmacol Sci. 2010 Jun;14(6):555-61.
PubMed 20712264Papaleo E, Unfer V, Baillargeon JP, Chiu TT. Contribution of myo-inositol to reproduction. Eur J Obstet Gynecol Reprod Biol. 2009 Dec;147(2):120-3. doi: 10.1016/j.ejogrb.2009.09.008. Epub 2009 Oct 2.
PubMed 19800728Tamura H, Nakamura Y, Korkmaz A, Manchester LC, Tan DX, Sugino N, Reiter RJ. Melatonin and the ovary: physiological and pathophysiological implications. Fertil Steril. 2009 Jul;92(1):328-43. doi: 10.1016/j.fertnstert.2008.05.016. Epub 2008 Sep 18.
PubMed 18804205
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Oocyte Retrieval Using a Combined Therapy of Recombinant Follicle Stimulating Hormone (rFSH) and Inositol and Melatonin
- ClinicalTrials.gov ID
- NCT01267604
- Acronym / sponsor ID
- rFSH-INOPLUS
- Conditions
- Infertility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AGUNCO Obstetrics and Gynecology CentreUniversity, hospital or other
- Collaborators
- University of Modena and Reggio Emilia, Research Center for Reproductive Medicine Villa Mafalda
- Study start
- Dec 2010
- Primary completion
- Dec 2013 (actual)
- First posted
- 28 Dec 2010 (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.
An efficient protocol of ovarian stimulation is a key part of assisted reproductive technology. In order to obtain the highest oocyte retrieval with no adverse effects, numerous studies have evaluated the efficiency of the clinical approaches currently available.
Recent studies have shown that two natural compounds, such as inositol and melatonin, play an important role in oocyte maturation and quality. Therefore, the present study aims at investigating whether inositol and melatonin are able to improve the number of oocytes obtained after ovarian stimulation with Recombinant Follicle Stimulating Hormone (rFSH).
To this purpose, a randomized double-blind trial will be established where 150 healthy women in reproductive age undergoing to assistant reproductive technology (ART) because of male infertility will be divided in two groups. Group A will be treated with 225IU rFSH alone, group B will be treated with 225IU rFSH, 4g inositol and 3mg melatonin.
As primary outcome of the study, oocyte quality, total number of oocytes retrieved, clinical pregnancy rate and live birth rate will be evaluated in group A vs. group B.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recombinant FSH | Active comparator | Drug: Recombinant FSH (rFSH)225IU rFSH |
| Recombinant FSH Inositol Melatonin | Experimental | Dietary Supplement: rFSH + Inositol + Melatonin225IU rFSH, 4g Inositol and 3mg Melatonin |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female age 18-39 years
- BMI 18-30 kg/m2,
- Fewer than 3 prior oocyte retrievals,
- No fertility Problems
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Recombinant FSH (rFSH)225IU | Drug | Recombinant FSH |
| rFSH + Inositol + Melatonin225IU rFSH, 4g Inositol, 3mg Melatonin | Dietary supplement | Recombinant FSH Inositol Melatonin |
Primary outcome
Total oocyte number
Time frame: 2 weeks after pharmacological treatment
Number of clinical pregnancies
Time frame: 6 weeks after embryo transfer
Live birth rate
Time frame: 10 months after embryo transfer
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Background: PubMed 20712264Rizzo P, Raffone E, Benedetto V. Effect of the treatment with myo-inositol plus folic acid plus melatonin in comparison with a treatment with myo-inositol plus folic acid on oocyte quality and pregnancy outcome in IVF cycles. A prospective, clinical trial. Eur Rev Med Pharmacol Sci. 2010 Jun;14(6):555-61.
- Background: PubMed 19800728Papaleo E, Unfer V, Baillargeon JP, Chiu TT. Contribution of myo-inositol to reproduction. Eur J Obstet Gynecol Reprod Biol. 2009 Dec;147(2):120-3. doi: 10.1016/j.ejogrb.2009.09.008. Epub 2009 Oct 2.
- Background: PubMed 18804205Tamura H, Nakamura Y, Korkmaz A, Manchester LC, Tan DX, Sugino N, Reiter RJ. Melatonin and the ovary: physiological and pathophysiological implications. Fertil Steril. 2009 Jul;92(1):328-43. doi: 10.1016/j.fertnstert.2008.05.016. Epub 2008 Sep 18.
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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.
Vittorio Unfer, MD study director
AGUNCO Obstetrics and Gynecology Centre
Gianfranco Carlomagno, PhD principal investigator
AGUNCO Obstetrics and Gynecology Centre
La Sala Giovanni Battista, MD principal investigator
University of Modena and Reggio Emilia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Recombinant FSH (rFSH) and rFSH + Inositol + Melatonin in people with Infertility, run by AGUNCO Obstetrics and Gynecology Centre at 2 sites 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 4 inclusion and 0 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: withdrawn, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was withdrawn before enrolling participants, so there are no results.
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?
Total oocyte number (time frame: 2 weeks after pharmacological treatment). The study lists 3 primary outcomes in all. 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 NCT01267604, which also lists 3 linked publications.
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 20 Jul 2023.