Amount of FSH Units During Ovarian Stimulation Protocols Clinical Trial
Official title:
Use of Inositols Within IVF Protocols to Reduce Gonadotropin Administration
| NCT number | NCT04576546 |
| Other study ID # | MI_DCI_FSH |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | November 2, 2020 |
| Est. completion date | June 2022 |
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.
| Status | Recruiting |
| Enrollment | 30 |
| Est. completion date | June 2022 |
| Est. primary completion date | May 2022 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 40 Years |
| Eligibility | Inclusion Criteria: - Women undergoing IVF-ET procedure - HOMA-IR index < 2.0 - AMH in the range 1.0 - 2.0 ng/ml Exclusion Criteria: - History of cancelled IVF cycles - BMI < 20 kg/m2 or = 30 kg/m2 - Diagnosis of PCOS - Thyroid diseases - Presence of co-morbidities |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Clinica Alma Res | Roma |
| Lead Sponsor | Collaborator |
|---|---|
| Lo.Li.Pharma s.r.l |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | FSH units/retrieved oocyte | number of IU of recombinant FSH administered, normalized on the number of oocytes retrieved during the pick-up | 1 day (single time-point at ovulation) | |
| Secondary | Total FSH (IU) | total number of FSH IU used in the stimulation protocol | 1 day (single time-point at ovulation) | |
| Secondary | Duration of the stimulation | Number of days of the stimulation protocol till pick-up | 1 day (single time-point at ovulation) | |
| Secondary | number of viable oocytes | number of retrieved oocytes eligible for fortilization | 1 day (single time-point at oocyte pick-up) | |
| Secondary | oocyte quality | classification of oocyte quality before fertilization | 1 day (single time-point at oocyte pick-up) | |
| Secondary | embryo quality | evaluation of the quality of embryos after fertilization, before transfer | 1 day (single time-point at embryo transfer) |