Amount of FSH Units During Ovarian Stimulation ProtocolsNCT04576546
Inositols and FSH in IVF
A study testing D-chiro-inositol and Myo-inositol in people with Amount of FSH Units During Ovarian Stimulation Protocols, run by Lo.Li.Pharma s.r.l at 1 site in Italy.
Trial summary
Ovarian hyperstimulation syndrome (OHSS), although quite uncommon, represents the most serious complication of ovulation induction during in-vitro fertilization (IVF) protocols. The syndrome is triggered by exaggerated ovarian response to gonadotropins, which eventually leads to pathological manifestations that range… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Amount of FSH Units During Ovarian Stimulation Protocols
- What is being tested?
- D-chiro-inositol and Myo-inositol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 2 Nov 2020to 27 Feb 2024
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women undergoing IVF-ET procedure
- HOMA-IR index < 2.0
- AMH in the range 1.0 - 2.0 ng/ml
Who cannot join
- History of cancelled IVF cycles
- BMI < 20 kg/m2 or ≥ 30 kg/m2
- Diagnosis of PCOS
- Thyroid diseases
- Presence of co-morbidities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Inositols Within IVF Protocols to Reduce Gonadotropin Administration
Ovarian hyperstimulation syndrome (OHSS), although quite uncommon, represents the most serious complication of ovulation induction during in-vitro fertilization (IVF) protocols. The syndrome is triggered by exaggerated ovarian response to gonadotropins, which eventually leads to pathological manifestations that range from mild symptoms, such as abdominal discomfort, to life-threatening complications in the most severe cases. Prevention is paramount during fertilization programs and requires assessment of risk factors and close monitoring of risk markers. Clinicians quite generally consider unusually elevated estrogen levels as both indicator for OHSS and one possible etiological factor. In this scenario, myo-inositol (MYO) treatment proved to reduce the amount of FSH units and the duration of the stimulation protocol, decreasing the risk of OHSS onset. On the other hand, inconclusive evidence is available about the effect of D-chiro-inositol (DCI) supplementation within assisted reproductive treatments. The aim of the proposed pilot study is to assess the effect of DCI supplementation on the doses of FSH used in IVF-ET protocols, also with respect to MYO treatment.
- Being tested
- D-chiro-inositol, Myo-inositol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-chiro-inositolDietary supplement
Supplementation of D-chiro-inositol (1000 mg/die), starting at least 4 weeks before rFSH administration
Myo-inositolDietary supplement
Supplementation of myo-inositol (4 g/die), starting at least 4 weeks before rFSH administration
| Study group | Role | What they receive |
|---|---|---|
| comparator group | Active comparator | myo-inositol treatment Receives: Dietary Supplement: Myo-inositol |
| study group | Experimental | D-chiro-inositol treatment Receives: Dietary Supplement: D-chiro-inositol |
What is being measured
The primary outcome is the main question the study is designed to answer.
FSH units/retrieved oocyte
number of IU of recombinant FSH administered, normalized on the number of oocytes retrieved during the pick-up
Measured: 1 day (single time-point at ovulation)
Secondary outcomes (5)
Total FSH (IU)
total number of FSH IU used in the stimulation protocol
Measured: 1 day (single time-point at ovulation)
Duration of the stimulation
Number of days of the stimulation protocol till pick-up
Measured: 1 day (single time-point at ovulation)
number of viable oocytes
number of retrieved oocytes eligible for fortilization
Measured: 1 day (single time-point at oocyte pick-up)
oocyte quality
classification of oocyte quality before fertilization
Measured: 1 day (single time-point at oocyte pick-up)
embryo quality
evaluation of the quality of embryos after fertilization, before transfer
Measured: 1 day (single time-point at embryo transfer)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start2 Nov 2020
- Primary completion30 Nov 2023
- Study completion27 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amount of FSH Units During Ovarian Stimulation ProtocolsStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lo.Li.Pharma s.r.l
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04576546
- Sponsor's protocol ID
- MI_DCI_FSH
- Status last verified
- Jul 2025
- First submitted
- 30 Sep 2020
- Last updated
- 9 Jul 2025
- 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 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Inositols Within IVF Protocols to Reduce Gonadotropin Administration
- ClinicalTrials.gov ID
- NCT04576546
- Acronym / sponsor ID
- MI_DCI_FSH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Lo.Li.Pharma s.r.lIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 27 Feb 2024 (actual)
- First posted
- 6 Oct 2020 (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.
Ovarian hyperstimulation syndrome (OHSS), although quite uncommon, represents the most serious complication of ovulation induction during in-vitro fertilization (IVF) protocols. The syndrome is triggered by exaggerated ovarian response to gonadotropins, which eventually leads to pathological manifestations that range from mild symptoms, such as abdominal discomfort, to life-threatening complications in the most severe cases. Prevention is paramount during fertilization programs and requires assessment of risk factors and close monitoring of risk markers. Clinicians quite generally consider unusually elevated estrogen levels as both indicator for OHSS and one possible etiological factor. In this scenario, myo-inositol (MYO) treatment proved to reduce the amount of FSH units and the duration of the stimulation protocol, decreasing the risk of OHSS onset. On the other hand, inconclusive evidence is available about the effect of D-chiro-inositol (DCI) supplementation within assisted reproductive treatments. The aim of the proposed pilot study is to assess the effect of DCI supplementation on the doses of FSH used in IVF-ET protocols, also with respect to MYO treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| comparator group | Active comparator | Dietary Supplement: Myo-inositolmyo-inositol treatment |
| study group | Experimental | Dietary Supplement: D-chiro-inositolD-chiro-inositol treatment |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women undergoing IVF-ET procedure
- HOMA-IR index < 2.0
- AMH in the range 1.0 - 2.0 ng/ml
Key exclusion criteria (5 listed)
- History of cancelled IVF cycles
- BMI < 20 kg/m2 or ≥ 30 kg/m2
- Diagnosis of PCOS
- Thyroid diseases
- Presence of co-morbidities
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 |
|---|---|---|
| D-chiro-inositolSupplementation of D-chiro-inositol (1000 mg/die), starting at least 4 weeks before rFSH administration | Dietary supplement | study group |
| Myo-inositolSupplementation of myo-inositol (4 g/die), starting at least 4 weeks before rFSH administration | Dietary supplement | comparator group |
Primary outcome
FSH units/retrieved oocyte
Time frame: 1 day (single time-point at ovulation)
number of IU of recombinant FSH administered, normalized on the number of oocytes retrieved during the pick-up
5 secondary outcomes
Total FSH (IU)
Time frame: 1 day (single time-point at ovulation)
Duration of the stimulation
Time frame: 1 day (single time-point at ovulation)
number of viable oocytes
Time frame: 1 day (single time-point at oocyte pick-up)
oocyte quality
Time frame: 1 day (single time-point at oocyte pick-up)
embryo quality
Time frame: 1 day (single time-point at embryo transfer)
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 9 Jul 2025.
- Individual participant dataSharing planned: No
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 D-chiro-inositol and Myo-inositol in people with Amount of FSH Units During Ovarian Stimulation Protocols, run by Lo.Li.Pharma s.r.l 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 3 inclusion and 5 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 9 Jul 2025. 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.
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?
FSH units/retrieved oocyte (time frame: 1 day (single time-point at ovulation)). 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 9 Jul 2025.