Trials / Completed
CompletedNCT04576546
Inositols and FSH in IVF
Use of Inositols Within IVF Protocols to Reduce Gonadotropin Administration
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 300 (actual)
- Sponsor
- Lo.Li.Pharma s.r.l · Industry
- Sex
- Female
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Accepted
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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | D-chiro-inositol | Supplementation of D-chiro-inositol (1000 mg/die), starting at least 4 weeks before rFSH administration |
| DIETARY_SUPPLEMENT | Myo-inositol | Supplementation of myo-inositol (4 g/die), starting at least 4 weeks before rFSH administration |
Timeline
- Start date
- 2020-11-02
- Primary completion
- 2023-11-30
- Completion
- 2024-02-27
- First posted
- 2020-10-06
- Last updated
- 2025-07-09
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT04576546. Inclusion in this directory is not an endorsement.