Lipoic Acid Supplementation in IVF

January 18, 2017 updated by: Lo.Li.Pharma s.r.l
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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

172

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Thessaloniki, Greece
        • Iakentro Advanced Medical Centre, IVF Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ALA + P
Oral alpha-lipoic acid + vaginal Progesterone
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
Active Comparator: P
vaginal Progesterone
Drug: Vaginal Progesterone
200 mg Vaginal Progesterone (1 vaginal capsule/24h) from the day of the donors pick up until 8 week of pregnancy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of implants per cycle
Time Frame: 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.
Within 7 weeks after blastocystis transfer

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lo.Li.Pharma s.r.l

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

January 13, 2017

First Submitted That Met QC Criteria

January 17, 2017

First Posted (Estimate)

January 18, 2017

Study Record Updates

Last Update Posted (Estimate)

January 19, 2017

Last Update Submitted That Met QC Criteria

January 18, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALA_ImplRate

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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