NCT03023514

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 .

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 18, 2017

Completed
Last Updated

January 19, 2017

Status Verified

January 1, 2017

Enrollment Period

1.3 years

First QC Date

January 13, 2017

Last Update Submit

January 18, 2017

Conditions

Women Infertility

Keywords

Oocyte donationIVFLipoic acidImplantation rateEndometrial receptivity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Number of biochemical pregnancies per group

    Within 7 weeks after blastocystis transfer

  • Number of clinical pregnancies per group

    7 weeks of gestation

  • Number of live birth per group

    At delivery

  • Number of miscarriage per group

    Within 22 weeks of gestation

Study Arms (2)

ALA + P

EXPERIMENTAL

Oral alpha-lipoic acid + vaginal Progesterone

Dietary Supplement: Oral Lipoic acidDrug: Vaginal Progesterone

P

ACTIVE COMPARATOR

vaginal Progesterone

Drug: Vaginal Progesterone

Interventions

Oral Lipoic acidDIETARY_SUPPLEMENT

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

ALA + P
Vaginal ProgesteroneDRUG

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

ALA + PP

Eligibility Criteria

Age30 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Donors:
  • Polycystic ovaries
  • Endometriosis
  • Gynaecological or medical disorders.
  • Recipients:
  • Endocrinologic problems
  • Medication for chronic illness
  • Azoospermic partner that require TESE
  • Sperm donation cycles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iakentro Advanced Medical Centre, IVF Unit

Thessaloniki, Greece

Location

Related Publications (2)

  • 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.

    PMID: 27292272BACKGROUND

  • 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.

    PMID: 23223073BACKGROUND

MeSH Terms

Interventions

Thioctic Acid

Intervention Hierarchy (Ancestors)

Carboxylic AcidsOrganic ChemicalsThiophenesSulfur CompoundsCoenzymesEnzymes and CoenzymesFatty AcidsLipids

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2017

First Posted

January 18, 2017

Study Start

March 1, 2015

Primary Completion

June 1, 2016

Last Updated

January 19, 2017

Record last verified: 2017-01

Locations

GR(1)