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

February 23, 2012 updated by: AGUNCO Obstetrics and Gynecology Centre
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy
        • Praxi Pro Vita Centro di Fertilità

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

27 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inofolic plus
178 patients
Dietary supplement: Myo-inositol + folic acid + melatonin
Myo-inositol (2000mg)+ folic acid (200 mcg)+ melatonin(3 mg)
Active Comparator: Inofolic
180 patients
Dietary supplement: Myo-inositol + folic acid
Myo-inositol (2000mg) + folic acid (200 mcg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Number of mature oocytes
embryo quality
Pregnancy rate
Implantation rate

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AGUNCO Obstetrics and Gynecology Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

February 17, 2012

First Submitted That Met QC Criteria

February 23, 2012

First Posted (Estimate)

February 29, 2012

Study Record Updates

Last Update Posted (Estimate)

February 29, 2012

Last Update Submitted That Met QC Criteria

February 23, 2012

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mel_FF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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