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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AGUNCO Obstetrics and Gynecology Centre
ClinicalTrials.gov Identifier:
NCT01540747
First received: February 17, 2012
Last updated: February 23, 2012
Last verified: January 2009
History of Changes
  Purpose

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).


Condition Intervention Phase
Polycystic Ovary Syndrome
 Dietary Supplement: Myo-inositol + folic acid + melatonin
Dietary Supplement: Myo-inositol + folic acid
 Phase 4

Study Type: Interventional

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AGUNCO Obstetrics and Gynecology Centre:

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)

Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   27 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01540747

Locations
Italy
Praxi Pro Vita Centro di Fertilità
Rome, Italy
Sponsors and Collaborators
AGUNCO Obstetrics and Gynecology Centre
  More Information

No publications provided

Responsible Party: AGUNCO Obstetrics and Gynecology Centre
ClinicalTrials.gov Identifier: NCT01540747     History of Changes
Other Study ID Numbers: Mel_FF
Study First Received: February 17, 2012
Last Updated: February 23, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by AGUNCO Obstetrics and Gynecology Centre:
intrafollicular melatonin
PCOS
embryos quality
oocytes quality

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Folic Acid
Vitamin B Complex
Inositol
Hematinics
 Melatonin
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematologic Agents
Therapeutic Uses
Central Nervous System Depressants
Central Nervous System Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on May 16, 2013