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

Polycystic Ovary Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01540747
• Other study ID #: Mel_FF
• Status: Completed
• Phase: Phase 4
• First received: February 17, 2012
• Last updated: February 23, 2012

Study information

• Verified date: January 2009
• Source: AGUNCO Obstetrics and Gynecology Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 27 Years to 38 Years

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome

Intervention

Dietary Supplement:
• Myo-inositol + folic acid + melatonin
Myo-inositol (2000mg)+ folic acid (200 mcg)+ melatonin(3 mg)
• Myo-inositol + folic acid
Myo-inositol (2000mg) + folic acid (200 mcg)

Locations

Country	Name	City	State
Italy	Praxi Pro Vita Centro di Fertilità	Rome

Sponsors (1)

Lead Sponsor	Collaborator
AGUNCO Obstetrics and Gynecology Centre

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of mature oocytes
Primary	embryo quality
Primary	Pregnancy rate
Primary	Implantation rate
Secondary	Total dose of FSH administered
Secondary	Number of days of stimulation
Secondary	Serum estradiol levels
Secondary	Endometrial thickness	Endometrial thickness on the day of human chorionic gonadotropin (hCG) administration
Secondary	Cancellation rate
Secondary	Incidence of moderate or severe ovaric hyperstimulation syndrome (OHSS)