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

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Myo-inositol + folic acid + melatonin
Myo-inositol + folic acid
Sponsored by
AGUNCO Obstetrics and Gynecology Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Polycystic Ovary Syndrome focused on measuring intrafollicular melatonin, PCOS, embryos quality, oocytes quality

Eligibility Criteria

27 Years - 38 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Praxi Pro Vita Centro di Fertilità

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Inofolic plus

Inofolic

Arm Description

178 patients

180 patients

Outcomes

Primary Outcome Measures

Number of mature oocytes
embryo quality
Pregnancy rate
Implantation rate

Secondary Outcome Measures

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)

Full Information

First Posted
February 17, 2012
Last Updated
February 23, 2012
Sponsor
AGUNCO Obstetrics and Gynecology Centre
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1. Study Identification

Unique Protocol Identification Number
NCT01540747
Brief Title
Role of Melatonin Supplementation in Follicular Fluid of in Vitro Fertilization (IVF) Patients With Polycystic Ovarian Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
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3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AGUNCO Obstetrics and Gynecology Centre

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
intrafollicular melatonin, PCOS, embryos quality, oocytes quality

7. Study Design

Study Phase
Phase 4

8. Arms, Groups, and Interventions

Arm Title
Inofolic plus
Arm Type
Experimental
Arm Description
178 patients
Arm Title
Inofolic
Arm Type
Active Comparator
Arm Description
180 patients
Intervention Type
Dietary Supplement
Intervention Name(s)
Myo-inositol + folic acid + melatonin
Intervention Description
Myo-inositol (2000mg)+ folic acid (200 mcg)+ melatonin(3 mg)
Intervention Type
Dietary Supplement
Intervention Name(s)
Myo-inositol + folic acid
Intervention Description
Myo-inositol (2000mg) + folic acid (200 mcg)
Primary Outcome Measure Information:
Title
Number of mature oocytes
Title
embryo quality
Title
Pregnancy rate
Title
Implantation rate
Secondary Outcome Measure Information:
Title
Total dose of FSH administered
Title
Number of days of stimulation
Title
Serum estradiol levels
Title
Endometrial thickness
Description
Endometrial thickness on the day of human chorionic gonadotropin (hCG) administration
Title
Cancellation rate
Title
Incidence of moderate or severe ovaric hyperstimulation syndrome (OHSS)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
27 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Praxi Pro Vita Centro di Fertilità
City
Rome
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

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