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The effect of myo-inositol, vitamin D3 and melatonin on the oocyte quality and pregnancy in in vitro fertilization: a randomized prospective controlled trial.

  • 2020-08-01
  • European review for medical and pharmacological sciences 24(16)
    • A Wdowiak
    • M Filip

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 100
Population
100 women undergoing ICSI procedure
Methods
Randomly divided 1:1 in two groups; study group treated with 2 g MI, 50 mg Alpha-Lactalbumin and 200 µg folic acid in powder every morning for 6 months, plus 600 mg MI, 1 mg melatonin and 200 µg folic acid during the evening for 3 months before oocyte pick up, then 600 mg MI, 200 µg folic acid, 1 mg melatonin, 50 µg vitamin D3 until the 12th week of gestation; control group treated with 200 µg folic acid twice a day
Duration
6 months (3 months before oocyte pick up and 3 months after ICSI)
  • Large Human Trial

Objective

To evaluate the efficacy of a treatment with Myo-inositol (MI) plus melatonin and vitamin D3 in women underwent intra cytoplasmatic sperm injection (ICSI).

Patients and methods

100 women undergoing ICSI procedure were enrolled and randomly divided 1:1 in two groups. The study group was treated with 2 g MI, 50 mg Alpha-Lactalbumin (alpha-LA) and 200 µg folic acid in powder every morning for 6 months (3 months before oocyte pick up and 3 months after ICSI); the same patients underwent treatment with 600 mg MI, 1 mg melatonin plus 200 µg folic acid during the evening for 3 months before oocyte pick up; subsequently the pick up these patients were treated with 600 mg MI, 200 µg folic acid, 1 mg melatonin, 50 µg vitamin D3 as cholecalciferol until the 12th week of gestation. The control group was treated with 200 µg folic acid twice a day. Clinical pregnancy rate was evaluated as primary outcome, followed by blastocyst and oocyte quality, as well as gestational period as secondary outcomes.

Results

Treatment significantly improved blastocyst and oocyte quality in the study group, achieving the 42% of clinical pregnancies vs. 24% in the control group, even though the course of pregnancy did not significantly differ between the groups. However, the mean gestational period was shorter in the control group.

Conclusions

The supplementation of MI in combination with melatonin in the first 3 months before oocyte pick up and with vitamin D3 in the further 3 months could represent an innovative support for all those women undergoing ICSI.

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