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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01540747
Recruitment Status : Completed
First Posted : February 29, 2012
Last Update Posted : February 29, 2012
Information provided by (Responsible Party):
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).

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

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.

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Study Type : Interventional  (Clinical Trial)

Resource links provided by the National Library of Medicine

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)

Primary Outcome Measures :
  1. Number of mature oocytes
  2. embryo quality
  3. Pregnancy rate
  4. Implantation rate

Secondary Outcome Measures :
  1. Total dose of FSH administered
  2. Number of days of stimulation
  3. Serum estradiol levels
  4. Endometrial thickness
    Endometrial thickness on the day of human chorionic gonadotropin (hCG) administration

  5. Cancellation rate
  6. Incidence of moderate or severe ovaric hyperstimulation syndrome (OHSS)

Information from the National Library of Medicine

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Ages Eligible for Study:   27 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01540747

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

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Responsible Party: AGUNCO Obstetrics and Gynecology Centre Identifier: NCT01540747     History of Changes
Other Study ID Numbers: Mel_FF
First Posted: February 29, 2012    Key Record Dates
Last Update Posted: February 29, 2012
Last Verified: January 2009
Keywords provided by AGUNCO Obstetrics and Gynecology Centre:
intrafollicular melatonin
embryos quality
oocytes quality
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Pathologic Processes
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Folic Acid
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Growth Substances