Lipoic Acid Supplementation in IVF

NCT ID: NCT03023514

Last Updated: 2017-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31

Brief 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 .

Conditions

Women Infertility

Study Design

• Allocation Method: RANDOMIZED

Study Groups

ALA + P

Oral alpha-lipoic acid + vaginal Progesterone

Group Type: EXPERIMENTAL

Oral Lipoic acid

Intervention Type: DIETARY_SUPPLEMENT

300 mg ALA x2 (1pill orally/12h) to the recipient from the day of the donors pick up until 8 week of pregnancy

Vaginal Progesterone

Intervention Type: DRUG

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

P

vaginal Progesterone

Group Type: ACTIVE_COMPARATOR

Vaginal Progesterone

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Vaginal Progesterone

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Lo.Li.Pharma s.r.l

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Iakentro Advanced Medical Centre, IVF Unit

Thessaloniki, , Greece

Countries

Greece

References

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. doi: 10.1080/17425247.2016.1200556. Epub 2016 Jun 24.

Reference Type: BACKGROUND

PMID: 27292272 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23223073 (View on PubMed)

Other Identifiers

ALA_ImplRate

Identifier Type: -

Identifier Source: org_study_id