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OpenTrials
Completed

NCT Number: NCT01540747

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

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).

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Key information

Age range

27 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Praxi Pro Vita Centro di Fertilità

Rome, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Myo-inositol + folic acid + melatonin

Dietary Supplement

Myo-inositol (2000mg)+ folic acid (200 mcg)+ melatonin(3 mg)

Myo-inositol + Folic acid

Dietary Supplement

Myo-inositol (2000mg) + folic acid (200 mcg)

Primary outcomes

  1. Number of mature oocytes

  2. embryo quality

  3. Pregnancy rate

  4. Implantation rate

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

AGUNCO Obstetrics and Gynecology Centre

Other

Registry information

Important dates

First posted
Feb 29, 2012
Registry last updated
Feb 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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