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Ovarian Stimulation: Inositol and Melatonin

NCT01267604 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2023-07-20

No results posted yet for this study

Summary

An efficient protocol of ovarian stimulation is a key part of assisted reproductive technology. In order to obtain the highest oocyte retrieval with no adverse effects, numerous studies have evaluated the efficiency of the clinical approaches currently available.

Recent studies have shown that two natural compounds, such as inositol and melatonin, play an important role in oocyte maturation and quality. Therefore, the present study aims at investigating whether inositol and melatonin are able to improve the number of oocytes obtained after ovarian stimulation with Recombinant Follicle Stimulating Hormone (rFSH).

To this purpose, a randomized double-blind trial will be established where 150 healthy women in reproductive age undergoing to assistant reproductive technology (ART) because of male infertility will be divided in two groups. Group A will be treated with 225IU rFSH alone, group B will be treated with 225IU rFSH, 4g inositol and 3mg melatonin.

As primary outcome of the study, oocyte quality, total number of oocytes retrieved, clinical pregnancy rate and live birth rate will be evaluated in group A vs. group B.

Conditions

Interventions

DRUG

Recombinant FSH (rFSH)

225IU

DIETARY_SUPPLEMENT

rFSH + Inositol + Melatonin

225IU rFSH, 4g Inositol, 3mg Melatonin

Sponsors & Collaborators

  • University of Modena and Reggio Emilia

    collaborator OTHER

  • Research Center for Reproductive Medicine Villa Mafalda

    collaborator UNKNOWN

  • AGUNCO Obstetrics and Gynecology Centre

    lead OTHER

Principal Investigators

  • Vittorio Unfer, MD · AGUNCO Obstetrics and Gynecology Centre

  • Gianfranco Carlomagno, PhD · AGUNCO Obstetrics and Gynecology Centre

  • La Sala Giovanni Battista, MD · University of Modena and Reggio Emilia

  • Franco Lisi, MD · Research Center for Reproductive Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2013-12-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01267604 on ClinicalTrials.gov