Lipoic Acid Supplementation in IVF

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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 .

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lo.Li.Pharma s.r.l
• Treatments: Progesterone; Thioctic Acid

Criteria

Inclusion Criteria:

Donors:

• Proof of fertility;

• ⩽32 years old

• BMI <30 kg/m2

• Regular menstrual cycles of 25-33 days

• Two normal ovaries based on transvaginal scan findings.

Recipients:

• Women with infertility problems

• ⩽50 years old,

• BMI <34 kg/m2

Exclusion Criteria:

Donors:

• Polycystic ovaries

• Endometriosis

• Gynaecological or medical disorders.

Recipients:

• Endocrinologic problems

• Medication for chronic illness

• Azoospermic partner that require TESE

• Sperm donation cycles