Study Results
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Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2010-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Recombinant FSH
225IU rFSH
Recombinant FSH (rFSH)
225IU
Recombinant FSH Inositol Melatonin
225IU rFSH, 4g Inositol and 3mg Melatonin
rFSH + Inositol + Melatonin
225IU rFSH, 4g Inositol, 3mg Melatonin
Interventions
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Recombinant FSH (rFSH)
225IU
rFSH + Inositol + Melatonin
225IU rFSH, 4g Inositol, 3mg Melatonin
Eligibility Criteria
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Inclusion Criteria
* BMI 18-30 kg/m2,
* Fewer than 3 prior oocyte retrievals,
* No fertility Problems
18 Years
39 Years
FEMALE
Yes
Sponsors
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University of Modena and Reggio Emilia
OTHER
Research Center for Reproductive Medicine Villa Mafalda
UNKNOWN
AGUNCO Obstetrics and Gynecology Centre
OTHER
Responsible Party
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Principal Investigators
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Vittorio Unfer, MD
Role: STUDY_DIRECTOR
AGUNCO Obstetrics and Gynecology Centre
Gianfranco Carlomagno, PhD
Role: PRINCIPAL_INVESTIGATOR
AGUNCO Obstetrics and Gynecology Centre
La Sala Giovanni Battista, MD
Role: PRINCIPAL_INVESTIGATOR
University of Modena and Reggio Emilia
Franco Lisi, MD
Role: PRINCIPAL_INVESTIGATOR
Research Center for Reproductive Medicine
Locations
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University of Modena and Reggio Emilia
Reggio Emilia, , Italy
Research Center for Reproductive Medicine Villa Mafalda
Roma, , Italy
Countries
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References
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Rizzo P, Raffone E, Benedetto V. Effect of the treatment with myo-inositol plus folic acid plus melatonin in comparison with a treatment with myo-inositol plus folic acid on oocyte quality and pregnancy outcome in IVF cycles. A prospective, clinical trial. Eur Rev Med Pharmacol Sci. 2010 Jun;14(6):555-61.
Papaleo E, Unfer V, Baillargeon JP, Chiu TT. Contribution of myo-inositol to reproduction. Eur J Obstet Gynecol Reprod Biol. 2009 Dec;147(2):120-3. doi: 10.1016/j.ejogrb.2009.09.008. Epub 2009 Oct 2.
Tamura H, Nakamura Y, Korkmaz A, Manchester LC, Tan DX, Sugino N, Reiter RJ. Melatonin and the ovary: physiological and pathophysiological implications. Fertil Steril. 2009 Jul;92(1):328-43. doi: 10.1016/j.fertnstert.2008.05.016. Epub 2008 Sep 18.
Other Identifiers
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rFSH-INOPLUS
Identifier Type: -
Identifier Source: org_study_id
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