Myo-inositol and Vitamin D3 During IVF

NCT04019899 | Completed

• 1 other identifier: 000153
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Female Infertility

Outcome Measures

Primary Outcomes (3)

• Implantation rate

  number of gestational sacs observed at ecographic screening divided by the number of embryos transferred

  Single time-point: at 6 weeks of pregnancy

• oocyte and embryo quality

  Classification of the morphological aspects under the optical microscope

  Single time-point: respectively, 12 days and 15 days after the beginning of Controlled Ovarian Hyperstimulation

• clinical pregnancy

  Positive beta-hCG test after embryo transfer

  Single time-point: at 14 days from embryo transfer

Secondary Outcomes (3)

• Gemellarity

  Single time-point: at 6 weeks of pregnancy

• Abortion rate

  Single time-point: at 6 weeks of pregnancy

• Number of FSH IU used for controlled ovarian hyperstimulation

  Single time-point: about 10 days after the beginning of Controlled Ovarian Hyperstimulation

Study Arms (2)

Control group

ACTIVE COMPARATOR

Dietary Supplement: control group

Study group

EXPERIMENTAL

Dietary Supplement: study group

Interventions

control group DIETARY_SUPPLEMENT

* 2 g Myo-Inositol, 50 mg Alpha-Lactalbumin and 200 µg folic acid (1 sachet/day in the morning): from the first day of the menstrual cycle until 14 days after embryo transfer. If pregnancy occurs, until the 12th week of gestation. * 600 mg Myo-Inositol, 200 µg folic acid, 1 mg melatonin (1 soft capsule/day in the evening): from the first day of the menstrual cycle until hCG administration. If pregnancy occurs, until the 12th week of gestation.

Control group

study group DIETARY_SUPPLEMENT

* 2 g Myo-Inositol, 50 mg Alpha-Lactalbumin and 200 µg folic acid (1 sachet/day in the morning): from the first day of the menstrual cycle until 14 days after embryo transfer. If pregnancy occurs, until the 12th week of gestation. * 600 mg Myo-Inositol, 200 µg folic acid, 1 mg melatonin (1 soft capsule/day in the evening): from the first day of the menstrual cycle until hCG administration; * 600 mg Myo-Inositol, 200 µg folic acid, 1 mg melatonin, 50 µg vitamin D3 as cholecalciferol (1 soft capsule/day in the evening) substitutes the previous treatment at hCG administration and lasted until 14 days after embryo transfer. If pregnancy occurs, until the 12th week of gestation.

Study group

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lo.Li.Pharma s.r.l: lead

Study Sites (1)

Clinica Alma Res

Roma, RM, 00198, Italy

Location

MeSH Terms

Conditions

Infertility, Female

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 15, 2019
• Study Start: May 2, 2018
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: July 15, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)