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Completed

NCT Number: NCT03023514

Lipoic Acid Supplementation in IVF

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 .

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Key information

Conditions

Women Infertility

Age range

30 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Iakentro Advanced Medical Centre, IVF Unit

Thessaloniki, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral Lipoic acid

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

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Number of biochemical pregnancies per group

    Time frame: Within 7 weeks after blastocystis transfer

    Positive β-human chorionic gonadotropin (hCG) test

  2. 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.

  3. Number of live birth per group

    Time frame: At delivery

  4. Number of miscarriage per group

    Time frame: Within 22 weeks of gestation

Sponsors and collaborators

Lead sponsor

Lo.Li.Pharma s.r.l

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
First posted
Jan 18, 2017
Registry last updated
Jan 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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