Women Infertility
Conditions
Keywords
Oocyte donation, IVF, Lipoic acid, Implantation rate, Endometrial receptivity
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 .
Interventions
DIETARY_SUPPLEMENTOral 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
DRUGVaginal Progesterone
200 mg Vaginal Progesterone (1 vaginal capsule/24h) from the day of the donors pick up until 8 week of pregnancy
Sponsors
Lo.Li.Pharma s.r.l
Study design
Allocation
RANDOMIZED
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of implants per cycle | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of biochemical pregnancies per group | Within 7 weeks after blastocystis transfer | Positive β-human chorionic gonadotropin (hCG) test |
| Number of clinical pregnancies per group | 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. |
| Number of live birth per group | At delivery | — |
| Number of miscarriage per group | Within 22 weeks of gestation | — |
Countries
Greece
Outcome results
None listed