Myo-inositol and Vitamin D3 During IVF

Not Applicable

Completed

• Conditions: Female Infertility
• Interventions: Dietary Supplement: study group; Dietary Supplement: control group

• Registration Number: NCT04019899
• Lead Sponsor: Lo.Li.Pharma s.r.l

Brief Summary

Administration of a multicomponent dietary supplement (myo-inositol, vitamin D3, folic acid and melatonin) to women undergoing IVF procedures.

The aim of the study is to monitor the effects on the pregnancy, implantation and abortion rates.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-02
• Primary Completion: 2019-05-31
• Study Completion: 2019-05-31
• Status Verified: 2019-07
• Study First Submitted: 2019-07-10
• Study First Submitted QC: 2019-07-12
• Last Update Submitted: 2019-07-12
• Study First Posted: 2019-07-15
• Last Update Posted: 2019-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• BMI (kg/m2): 18.5 - 24.9
• basal FSH on day 3 <15 mIU/ml

Exclusion Criteria

• presence of insulin resistance (IR)
• hyperglycaemia, hyperprolactinemia, hypothyroidism or androgen excess
• diagnosis of PCOS (according to Rotterdam ESHRE-ASRM Sponsored PCOS consensus workshop group)
• intake of hormones or drugs that can potentially influence the ovulation
• FSH>15 on day 3

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	study group	-
Control group	control group	-

Primary Outcome Measures

Name	Time	Method
clinical pregnancy	Single time-point: at 14 days from embryo transfer	Positive beta-hCG test after embryo transfer
Implantation rate	Single time-point: at 6 weeks of pregnancy	number of gestational sacs observed at ecographic screening divided by the number of embryos transferred
oocyte and embryo quality	Single time-point: respectively, 12 days and 15 days after the beginning of Controlled Ovarian Hyperstimulation	Classification of the morphological aspects under the optical microscope

Secondary Outcome Measures

Name	Time	Method
Gemellarity	Single time-point: at 6 weeks of pregnancy	Multiple gestational sacs observed at ecographic screening
Abortion rate	Single time-point: at 6 weeks of pregnancy	Loss of pregnancy
Number of FSH IU used for controlled ovarian hyperstimulation	Single time-point: about 10 days after the beginning of Controlled Ovarian Hyperstimulation	Ovarian ultrasound investigation and serum estradiol level

Trial Locations

Locations (1)

Clinica Alma Res; 🇮🇹 Roma, RM, Italy