Lipoic Acid Supplementation in IVF

Phase 4

Completed

• Conditions: Women Infertility
• Interventions: Dietary Supplement: Oral Lipoic acid; Drug: Vaginal Progesterone

• Registration Number: NCT03023514
• Lead Sponsor: Lo.Li.Pharma s.r.l

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Primary Completion: 2016-06
• Status Verified: 2017-01
• Study First Submitted: 2017-01-13
• Study First Submitted QC: 2017-01-17
• Study First Posted: 2017-01-18
• Last Update Submitted: 2017-01-18
• Last Update Posted: 2017-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 172

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ALA + P	Oral Lipoic acid	Oral alpha-lipoic acid + vaginal Progesterone
ALA + P	Vaginal Progesterone	Oral alpha-lipoic acid + vaginal Progesterone
P	Vaginal Progesterone	vaginal Progesterone

Primary Outcome Measures

Name	Time	Method
Number of implants per cycle	Within 7 weeks after blastocystis transfer	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.

Secondary Outcome Measures

Name	Time	Method
Number of miscarriage per group	Within 22 weeks of gestation
Number of biochemical pregnancies per group	Within 7 weeks after blastocystis transfer	Positive β-human chorionic gonadotropin (hCG) test
Number of live birth per group	At delivery
Number of clinical pregnancies per group	7 weeks of gestation	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.

Trial Locations

Locations (1)

Iakentro Advanced Medical Centre, IVF Unit; 🇬🇷 Thessaloniki, Greece