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Completed

NCT Number: NCT04019899

Myo-inositol and Vitamin D3 During IVF

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.

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Key information

Conditions

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

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Clinica Alma Res

Roma, RM, 00198, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Implantation rate

    Time frame: Single time-point: at 6 weeks of pregnancy

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

  2. oocyte and embryo quality

    Time frame: 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

  3. clinical pregnancy

    Time frame: Single time-point: at 14 days from embryo transfer

    Positive beta-hCG test after embryo transfer

Secondary outcomes

  1. Gemellarity

    Time frame: Single time-point: at 6 weeks of pregnancy

    Multiple gestational sacs observed at ecographic screening

  2. Abortion rate

    Time frame: Single time-point: at 6 weeks of pregnancy

    Loss of pregnancy

  3. Number of FSH IU used for controlled ovarian hyperstimulation

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

    Ovarian ultrasound investigation and serum estradiol level

Sponsors and collaborators

Lead sponsor

Lo.Li.Pharma s.r.l

Industry

Registry information

Official study title

Effects of Supplementation With Myo-inositol, Vitamin D3, Folic Acid and Melatonin on IVF Outcomes

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 15, 2019
Registry last updated
Jul 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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