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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
* 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.
* 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.
Clinica Alma Res
Roma, RM, Italy
Implantation rate
number of gestational sacs observed at ecographic screening divided by the number of embryos transferred
Time frame: Single time-point: at 6 weeks of pregnancy
oocyte and embryo quality
Classification of the morphological aspects under the optical microscope
Time frame: 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
Time frame: Single time-point: at 14 days from embryo transfer
Gemellarity
Multiple gestational sacs observed at ecographic screening
Time frame: Single time-point: at 6 weeks of pregnancy
Abortion rate
Loss of pregnancy
Time frame: Single time-point: at 6 weeks of pregnancy
Number of FSH IU used for controlled ovarian hyperstimulation
Ovarian ultrasound investigation and serum estradiol level
Time frame: Single time-point: about 10 days after the beginning of Controlled Ovarian Hyperstimulation
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