Alpha-Lipoic Acid (ALA) is a natural molecule that can make a significant contribution to the success of embryo implantation phase, because it exerts, directly or indirectly, an immunomodulatory activity. ALA has the ability to regenerate antioxidants molecules that facilitate embryo implantation, and to stimulate the production of local mediators useful for implantation. This study is a prospective clinical trial and aims to evaluate the reproductive outcomes of Italian couples following oocyte donation fresh cycles when receiving per os tablets of lipoic acid. Indeed, the control group had only the standard treatment (vaginal progesterone), whereas the study group, in addition to that, received ALA (300 mg, 2 times per day) by oral route, from the day of donors oocyte pick up until the pregnancy test. If the childbearing occurred, treatment continued until the 8th week of pregnancy. Primary outcome of the study is the implantation rate while the positive hCG rate, the clinical pregnancy rate, the miscarriage rate and the live-birth rate are secondary outcomes .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Enrollment
172
300 mg ALA x2 (1pill orally/12h) to the recipient from the day of the donors pick up until 8 week of pregnancy
200 mg Vaginal Progesterone (1 vaginal capsule/24h) from the day of the donors pick up until 8 week of pregnancy
Iakentro Advanced Medical Centre, IVF Unit
Thessaloniki, Greece
Number of implants per cycle
Implantation rate is defined as the percentage of transferred embryos that develop at least to the stage of fetal heart activity documented by pregnancy ultrasound.
Time frame: Within 7 weeks after blastocystis transfer
Number of biochemical pregnancies per group
Positive β-human chorionic gonadotropin (hCG) test
Time frame: Within 7 weeks after blastocystis transfer
Number of clinical pregnancies per group
A positive β-hCG test and a fetal heart beat seen by ultrasound at 7 weeks of gestation was defined as a clinical pregnancy, otherwise it was considered a biochemical pregnancy.
Time frame: 7 weeks of gestation
Number of live birth per group
Time frame: At delivery
Number of miscarriage per group
Time frame: Within 22 weeks of gestation
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