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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT03023514
Date of registration: 13/01/2017
Prospective Registration: No
Primary sponsor: Lo.Li.Pharma s.r.l
Public title: Lipoic Acid Supplementation in IVF
Scientific title:
Date of first enrolment: March 2015
Target sample size: 172
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03023514
Study type:  Interventional
Study design:  Allocation: Randomized.  
Phase:  Phase 4
Countries of recruitment
Greece
Contacts
Key inclusion & exclusion criteria

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



Age minimum: 30 Years
Age maximum: 50 Years
Gender: Female
Health Condition(s) or Problem(s) studied
Women Infertility
Intervention(s)
Dietary Supplement: Oral Lipoic acid
Drug: Vaginal Progesterone
Primary Outcome(s)
Number of implants per cycle [Time Frame: Within 7 weeks after blastocystis transfer]
Secondary Outcome(s)
Number of miscarriage per group [Time Frame: Within 22 weeks of gestation]
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]
Secondary ID(s)
ALA_ImplRate
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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