An interventional study of control group and study group in Female Infertility, sponsored by Lo.Li.Pharma s.r.l. Completed at 1 site in Italy. Open to female participants aged 18 Years to 42 Years. Per ClinicalTrials.gov, last updated 2019-07-15.
Sponsored by Lo.Li.Pharma s.r.l · Not applicable, Interventional, and Treatment
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.
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's enrollment of 120 is close to the median of 120 across 1,698 interventional studies indexed under Infertility.
Browse Infertility studies →Lo.Li.Pharma s.r.l is the lead sponsor of 30 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dietary Supplement: control group
Dietary Supplement: study 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.
* 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.
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
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Lo.Li.Pharma s.r.l