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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

December 23, 2010
December 27, 2010
December 2010
Not Provided
  • 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 ]
Same as current
Complete list of historical versions of study NCT01267604 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Ovarian Stimulation: Inositol and Melatonin
Improving Oocyte Retrieval Using a Combined Therapy of Recombinant Follicle Stimulating Hormone (rFSH) and Inositol and Melatonin

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Infertility
  • Drug: Recombinant FSH (rFSH)
    225IU
  • Dietary Supplement: rFSH + Inositol + Melatonin
    225IU rFSH, 4g Inositol, 3mg Melatonin
  • Active Comparator: Recombinant FSH
    225IU rFSH
    Intervention: Drug: Recombinant FSH (rFSH)
  • Experimental: Recombinant FSH Inositol Melatonin
    225IU rFSH, 4g Inositol and 3mg Melatonin
    Intervention: Dietary Supplement: rFSH + Inositol + Melatonin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
Not Provided
Not Provided

Inclusion Criteria:

  • Female age 18-39 years
  • BMI 18-30 kg/m2,
  • Fewer than 3 prior oocyte retrievals,
  • No fertility Problems
Female
18 Years to 39 Years
Yes
Contact: Vittorio Unfer, MD +39 0640500835 vunfer@gmail.com
Contact: Gianfranco Carlomagno, PhD gianfranco.carlomagno@gmail.com
Italy
 
NCT01267604
rFSH-INOPLUS
No
AGUNCO Obstetrics & Gynecology Center
AGUNCO Obstetrics and Gynecology Centre
  • University of Modena and Reggio Emilia
  • Research Center for Reproductive Medicine Villa Mafalda
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
AGUNCO Obstetrics and Gynecology Centre
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP