Role of Melatonin Supplementation in Follicular Fluid of in Vitro Fertilization (IVF) Patients With Polycystic Ovarian Syndrome
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|ClinicalTrials.gov Identifier: NCT01540747|
Recruitment Status : Completed
First Posted : February 29, 2012
Last Update Posted : February 29, 2012
|Condition or disease||Intervention/treatment||Phase|
|Polycystic Ovary Syndrome||Dietary Supplement: Myo-inositol + folic acid + melatonin Dietary Supplement: Myo-inositol + folic acid||Phase 4|
Polycystic ovarian syndrome (PCOS) is a common endocrine disorder that causes infertility due to anovulation in women of reproductive age. Anovulation and also decreased oocyte and embryo quality may be cause of infertility in women with PCOS. Furthermore, the reactive oxygen species (ROS) induce oxidative stress which may be responsible for poor oocyte quality. The ROS generation from mononuclear cells is elevated in women with PCOS and a significant increment of lipid peroxidation products in women with PCOS has been reported.
Melatonin is a documented powerful free radical scavenger and a broad spectrum antioxidant. It has been observed that a non-PCOS group co-treated with inositol, folic acid, and melatonin (Inofolic Plus by LO.LI.Pharma) results in a significantly greater mean number of mature oocytes, and a lower mean number of immature oocytes in patients with low oocyte quality history when compared to treatment only with inositol and folic acid (Inofolic by LO.LI.Pharma).
The aim of the study is to evaluate the possible effects of melatonin supplementation on the main IVF outcomes during ovarian stimulation of patients with PCOS.
From July 2009 to December 2011, 358 patients with PCOS (Rotterdam criteria) were enrolled in this prospective randomized controlled trial.
|Study Type :||Interventional (Clinical Trial)|
Experimental: Inofolic plus
Dietary Supplement: Myo-inositol + folic acid + melatonin
Myo-inositol (2000mg)+ folic acid (200 mcg)+ melatonin(3 mg)
Active Comparator: Inofolic
Dietary Supplement: Myo-inositol + folic acid
Myo-inositol (2000mg) + folic acid (200 mcg)
- Number of mature oocytes
- embryo quality
- Pregnancy rate
- Implantation rate
- Total dose of FSH administered
- Number of days of stimulation
- Serum estradiol levels
- Endometrial thicknessEndometrial thickness on the day of human chorionic gonadotropin (hCG) administration
- Cancellation rate
- Incidence of moderate or severe ovaric hyperstimulation syndrome (OHSS)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01540747
|Praxi Pro Vita Centro di Fertilità|