Inositols and FSH in IVF

Not Applicable

• Conditions: Amount of FSH Units During Ovarian Stimulation Protocols
• Interventions: Dietary Supplement: Myo-inositol; Dietary Supplement: D-chiro-inositol

• Registration Number: NCT04576546
• Lead Sponsor: Lo.Li.Pharma s.r.l

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-30
• Study First Submitted QC: 2020-10-05
• Study First Posted: 2020-10-06
• Study Start: 2020-11-02
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-25
• Last Update Posted: 2022-03-28
• Primary Completion: 2022-05
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
comparator group	Myo-inositol	myo-inositol treatment
study group	D-chiro-inositol	D-chiro-inositol treatment

Primary Outcome Measures

Name	Time	Method
FSH units/retrieved oocyte	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

Secondary Outcome Measures

Name	Time	Method
embryo quality	1 day (single time-point at embryo transfer)	evaluation of the quality of embryos after fertilization, before transfer
Total FSH (IU)	1 day (single time-point at ovulation)	total number of FSH IU used in the stimulation protocol
Duration of the stimulation	1 day (single time-point at ovulation)	Number of days of the stimulation protocol till pick-up
number of viable oocytes	1 day (single time-point at oocyte pick-up)	number of retrieved oocytes eligible for fortilization
oocyte quality	1 day (single time-point at oocyte pick-up)	classification of oocyte quality before fertilization

Trial Locations

Locations (1)

Clinica Alma Res; 🇮🇹 Roma, Italy