Women InfertilityPhase 4NCT03023514
Lipoic Acid Supplementation in IVF
A Phase 4 study testing Oral Lipoic acid and Vaginal Progesterone in people with Women Infertility, run by Lo.Li.Pharma s.r.l at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 50 years, women only
- Conditions the study is for
- Women Infertility
- What is being tested?
- Oral Lipoic acid and Vaginal Progesterone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteGreece
- Study dates
- Mar 2015to Jun 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Show all 10Show fewer
- Recipients:
- Women with infertility problems
- ⩽50 years old,
- BMI <34 kg/m2
Who cannot join
- Donors:
- Polycystic ovaries
- Endometriosis
- Gynaecological or medical disorders.
- Recipients:
- Endocrinologic problems
Show all 9Show fewer
- Medication for chronic illness
- Azoospermic partner that require TESE
- Sperm donation cycles
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Oral Lipoic acid, Vaginal Progesterone
- Keywords
- Oocyte donation, IVF, Lipoic acid, Implantation rate, Endometrial receptivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Vaginal ProgesteroneDrug
200 mg Vaginal Progesterone (1 vaginal capsule/24h) from the day of the donors pick up until 8 week of pregnancy
| Study group | Role | What they receive |
|---|---|---|
| ALA + P | Experimental | Oral alpha-lipoic acid + vaginal Progesterone Receives: Dietary Supplement: Oral Lipoic acid; Drug: Vaginal Progesterone |
| P | Active comparator | vaginal Progesterone Receives: Drug: Vaginal Progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 7 weeks after blastocystis transfer
Secondary outcomes (4)
Number of biochemical pregnancies per group
Positive β-human chorionic gonadotropin (hCG) test
Measured: Within 7 weeks after blastocystis transfer
Number of clinical pregnancies per group
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.
Measured: 7 weeks of gestation
Number of live birth per group
Measured: At delivery
Number of miscarriage per group
Measured: Within 22 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study startMar 2015
- Primary completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Women InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lo.Li.Pharma s.r.l
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03023514
- Sponsor's protocol ID
- ALA_ImplRate
- Status last verified
- Jan 2017
- First submitted
- 13 Jan 2017
- Last updated
- 19 Jan 2017
- Results posted
- No
Publications
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.
PubMed 27292272Cha 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.
PubMed 23223073
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipoic Acid Supplementation in IVF
- ClinicalTrials.gov ID
- NCT03023514
- Acronym / sponsor ID
- ALA_ImplRate
- Conditions
- Women Infertility
- Keywords
- Oocyte donation, IVF, Lipoic acid, Implantation rate, Endometrial receptivity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Lo.Li.Pharma s.r.lIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Jun 2016 (actual)
- First posted
- 18 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALA + P | Experimental | Dietary Supplement: Oral Lipoic acid, Drug: Vaginal ProgesteroneOral alpha-lipoic acid + vaginal Progesterone |
| P | Active comparator | Drug: Vaginal Progesteronevaginal Progesterone |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (9 listed)
- Polycystic ovaries
- Endometriosis
- Gynaecological or medical disorders.
- Endocrinologic problems
- Medication for chronic illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Lipoic acid300 mg ALA x2 (1pill orally/12h) to the recipient from the day of the donors pick up until 8 week of pregnancy | Dietary supplement | ALA + P |
| Vaginal Progesterone200 mg Vaginal Progesterone (1 vaginal capsule/24h) from the day of the donors pick up until 8 week of pregnancy | Drug | ALA + P, P |
Primary outcome
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.
4 secondary outcomes
Number of biochemical pregnancies per group
Time frame: Within 7 weeks after blastocystis transfer
Number of clinical pregnancies per group
Time frame: 7 weeks of gestation
Number of live birth per group
Time frame: At delivery
Number of miscarriage per group
Time frame: Within 22 weeks of gestation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2017.
- Background: PubMed 27292272Monastra 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.
- Background: PubMed 23223073Cha 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oral Lipoic acid and Vaginal Progesterone in people with Women Infertility, run by Lo.Li.Pharma s.r.l at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of implants per cycle (time frame: Within 7 weeks after blastocystis transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03023514, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2017.