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

Phase 4

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Dietary Supplement: Myo-inositol + folic acid + melatonin; Dietary Supplement: Myo-inositol + folic acid

• Registration Number: NCT01540747
• Lead Sponsor: AGUNCO Obstetrics and Gynecology Centre

Brief 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).

Detailed 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.

Study Timeline

• Status Verified: 2009-01
• Study First Submitted: 2012-02-17
• Study First Submitted QC: 2012-02-23
• Last Update Submitted: 2012-02-23
• Study First Posted: 2012-02-29
• Last Update Posted: 2012-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Inofolic plus	Myo-inositol + folic acid + melatonin	178 patients
Inofolic	Myo-inositol + folic acid	180 patients

Primary Outcome Measures

Name	Time	Method
embryo quality
Pregnancy rate
Number of mature oocytes
Implantation rate

Secondary Outcome Measures

Name	Time	Method
Total dose of FSH administered
Cancellation rate
Serum estradiol levels
Number of days of stimulation
Endometrial thickness		Endometrial thickness on the day of human chorionic gonadotropin (hCG) administration
Incidence of moderate or severe ovaric hyperstimulation syndrome (OHSS)

Trial Locations

Locations (1)

Praxi Pro Vita Centro di Fertilità; 🇮🇹 Rome, Italy