MedDataX Logo

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

NCT ID: NCT01540747

Last Updated: 2012-02-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Polycystic Ovary Syndrome

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

intrafollicular melatonin PCOS embryos quality oocytes quality

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Inofolic plus

178 patients

Group Type EXPERIMENTAL

Myo-inositol + folic acid + melatonin

Intervention Type DIETARY_SUPPLEMENT

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

Inofolic

180 patients

Group Type ACTIVE_COMPARATOR

Myo-inositol + folic acid

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Myo-inositol + folic acid + melatonin

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

Intervention Type DIETARY_SUPPLEMENT

Myo-inositol + folic acid

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

27 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AGUNCO Obstetrics and Gynecology Centre

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Praxi Pro Vita Centro di Fertilità

Rome, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Mel_FF

Identifier Type: -

Identifier Source: org_study_id