A Phase 4 interventional study of Oral Lipoic acid and Vaginal Progesterone in Women Infertility, sponsored by Lo.Li.Pharma s.r.l. Completed at 1 site in Greece. Open to female participants aged 30 Years to 50 Years. Per ClinicalTrials.gov, last updated 2017-01-19.
Sponsored by Lo.Li.Pharma s.r.l · Phase 4 and Interventional
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 .
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's enrollment of 172 is above 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.
Donors:
Recipients:
Exclusion Criteria:
Donors:
Recipients:
Oral alpha-lipoic acid + vaginal Progesterone
Dietary Supplement: Oral Lipoic acid · Drug: Vaginal Progesterone
vaginal Progesterone
Drug: Vaginal Progesterone
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
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
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Lo.Li.Pharma s.r.l