Lipoic Acid Supplementation in IVF

Women Infertility Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03023514
• Other study ID #: ALA_ImplRate
• Status: Completed
• Phase: Phase 4
• First received: January 13, 2017
• Last updated: January 18, 2017
• Start date: March 2015

Study information

• Verified date: January 2017
• Source: Lo.Li.Pharma s.r.l
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Women Infertility

Intervention

Dietary Supplement:
• Oral Lipoic acid
300 mg ALA x2 (1pill orally/12h) to the recipient from the day of the donors pick up until 8 week of pregnancy

Drug:
• Vaginal Progesterone
200 mg Vaginal Progesterone (1 vaginal capsule/24h) from the day of the donors pick up until 8 week of pregnancy

Locations

Country	Name	City	State
Greece	Iakentro Advanced Medical Centre, IVF Unit	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Lo.Li.Pharma s.r.l

Country where clinical trial is conducted

Greece, 

References & Publications (2)

Cha J, Sun X, Dey SK. Mechanisms of implantation: strategies for successful pregnancy. Nat Med. 2012 Dec;18(12):1754-67. doi: 10.1038/nm.3012. Review. — View Citation

Monastra G, De Grazia S, Cilaker Micili S, Goker A, Unfer V. Immunomodulatory activities of alpha lipoic acid with a special focus on its efficacy in preventing miscarriage. Expert Opin Drug Deliv. 2016 Dec;13(12):1695-1708. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Within 7 weeks after blastocystis transfer
Secondary	Number of biochemical pregnancies per group	Positive ß-human chorionic gonadotropin (hCG) test	Within 7 weeks after blastocystis transfer
Secondary	Number of clinical pregnancies per group	A positive ß-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.	7 weeks of gestation
Secondary	Number of live birth per group		At delivery
Secondary	Number of miscarriage per group		Within 22 weeks of gestation