Role of Melatonin Supplementation in Follicular Fluid of in Vitro Fertilization (IVF) Patients With Polycystic Ovarian Syndrome

AGUNCO Obstetrics and Gynecology Centre

Status and phase: Completed; Phase 4

Conditions: Polycystic Ovary Syndrome

Treatments: Dietary Supplement: Myo-inositol + folic acid + melatonin; Dietary Supplement: Myo-inositol + folic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT01540747

Mel_FF

Details and patient eligibility

About

To evaluate the effects of melatonin supplementation on the main in vitro fertilization (IVF) outcomes during ovarian stimulation in patients with Polycystic ovarian syndrome (PCOS).

Full description

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.

Sex: Female

Ages: 27 to 38 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of PCOS
• irregular menstrual cycle (> than 28-30 days)
• normal uterine cavity
• body mass index of 20 to 26 Kg/m2
• first IVF treatment

Exclusion criteria

• presence of tubal, uterine, genetics and male causes of infertility
• diagnosis of cancer
• hormonal treatment in the last six months

Trial design

0 participants in 2 patient groups

Inofolic plus

Experimental group

Description:

178 patients

Treatment:

Dietary Supplement: Myo-inositol + folic acid + melatonin

Inofolic

Active Comparator group

Description:

180 patients

Treatment:

Dietary Supplement: Myo-inositol + folic acid