Lipoic Acid Supplementation in IVF

Lo.Li.Pharma

Status and phase: Completed; Phase 4

Conditions: Women Infertility

Treatments: Drug: Vaginal Progesterone; Dietary Supplement: Oral Lipoic acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT03023514

ALA_ImplRate

Details and patient eligibility

About

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 .

Enrollment: 172 patients

Sex: Female

Ages: 30 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

172 participants in 2 patient groups

ALA + P

Experimental group

Description:

Oral alpha-lipoic acid + vaginal Progesterone

Treatment:

Dietary Supplement: Oral Lipoic acid

Drug: Vaginal Progesterone

P

Active Comparator group

Description:

vaginal Progesterone

Treatment:

Drug: Vaginal Progesterone