Female Infertility
Conditions
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.
Interventions
DIETARY_SUPPLEMENTcontrol group
* 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.
DIETARY_SUPPLEMENTstudy group
* 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.
Sponsors
Lo.Li.Pharma s.r.l
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| clinical pregnancy | Single time-point: at 14 days from embryo transfer | Positive beta-hCG test after embryo transfer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Outcome results
None listed