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Ovarian Stimulation: Inositol and Melatonin

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by AGUNCO Obstetrics and Gynecology Centre.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
University of Modena and Reggio Emilia
Research Center for Reproductive Medicine Villa Mafalda
Information provided by:
AGUNCO Obstetrics and Gynecology Centre
ClinicalTrials.gov Identifier:
NCT01267604
First received: December 23, 2010
Last updated: December 27, 2010
Last verified: December 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Infertility
 Drug: Recombinant FSH (rFSH)
Dietary Supplement: rFSH + Inositol + Melatonin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Improving Oocyte Retrieval Using a Combined Therapy of Recombinant Follicle Stimulating Hormone (rFSH) and Inositol and Melatonin

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by AGUNCO Obstetrics and Gynecology Centre:

Primary Outcome Measures:
  • Total oocyte number [ Time Frame: 2 weeks after pharmacological treatment ] [ Designated as safety issue: No ]
  • Number of clinical pregnancies [ Time Frame: 6 weeks after embryo transfer ] [ Designated as safety issue: No ]
  • Live birth rate [ Time Frame: 10 months after embryo transfer ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: December 2010
Arms Assigned Interventions
Active Comparator: Recombinant FSH
225IU rFSH
 Drug: Recombinant FSH (rFSH)
225IU
Experimental: Recombinant FSH Inositol Melatonin
225IU rFSH, 4g Inositol and 3mg Melatonin
 Dietary Supplement: rFSH + Inositol + Melatonin
225IU rFSH, 4g Inositol, 3mg Melatonin

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female age 18-39 years
  • BMI 18-30 kg/m2,
  • Fewer than 3 prior oocyte retrievals,
  • No fertility Problems
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01267604

Contacts
Contact: Vittorio Unfer, MD +39 0640500835 vunfer@gmail.com
Contact: Gianfranco Carlomagno, PhD gianfranco.carlomagno@gmail.com

Locations
Italy
University of Modena and Reggio Emilia Recruiting
Reggio Emilia, Italy, 42100
Contact: Giovanni Battista La Sala, MD     +39 0522 296464     giovanni.lasala@asmn.re.it    
Principal Investigator: Giovanni Battista La Sala, MD            
Research Center for Reproductive Medicine Villa Mafalda Recruiting
Roma, Italy, 00199
Contact: Franco Lisi, MD     +39 06 86094776     flisi@tin.it    
Principal Investigator: Franco Lisi, MD            
Sponsors and Collaborators
AGUNCO Obstetrics and Gynecology Centre
University of Modena and Reggio Emilia
Research Center for Reproductive Medicine Villa Mafalda
Investigators
Study Director: Vittorio Unfer, MD AGUNCO Obstetrics and Gynecology Centre
Principal Investigator: Gianfranco Carlomagno, PhD AGUNCO Obstetrics and Gynecology Centre
Principal Investigator: La Sala Giovanni Battista, MD University of Modena and Reggio Emilia
Principal Investigator: Franco Lisi, MD Research Center for Reproductive Medicine
  More Information

Publications:

Responsible Party: AGUNCO Obstetrics & Gynecology Center
ClinicalTrials.gov Identifier: NCT01267604     History of Changes
Other Study ID Numbers: rFSH-INOPLUS
Study First Received: December 23, 2010
Last Updated: December 27, 2010
Health Authority: Italy: National Institute of Health

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Inositol
Melatonin
Follicle Stimulating Hormone
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on May 16, 2013