Lipoic Acid Supplementation in IVF

Study Overview
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Brief Summary
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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
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Women Infertility

Intervention / Treatment
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* Dietary Supplement: Oral Lipoic acid
* Drug: Vaginal Progesterone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALA + P<br>Oral alpha-lipoic acid + vaginal Progesterone | Dietary Supplement: Oral Lipoic acid<br>* 300 mg ALA x2 (1pill orally/12h) to the recipient from the day of the donors pick up until 8 week of pregnancy<br>Drug: Vaginal Progesterone<br>* 200 mg Vaginal Progesterone (1 vaginal capsule/24h) from the day of the donors pick up until 8 week of pregnancy<br>|
| Active Comparator: P<br>vaginal Progesterone | Drug: Vaginal Progesterone<br>* 200 mg Vaginal Progesterone (1 vaginal capsule/24h) from the day of the donors pick up until 8 week of pregnancy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of biochemical pregnancies per group | Positive β-human chorionic gonadotropin (hCG) test | 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. | 7 weeks of gestation | 
| Number of live birth per group |  | At delivery | 
| Number of miscarriage per group |  | Within 22 weeks of gestation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVF, Oocyte donation, Lipoic acid, Implantation rate, Endometrial receptivity