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

Tracking Information

First Received Date ^ICMJE

December 23, 2010

Last Updated Date

December 27, 2010

Start Date ^ICMJE

December 2010

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01267604 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Ovarian Stimulation: Inositol and Melatonin

Official Title ^ICMJE

Improving Oocyte Retrieval Using a Combined Therapy of Recombinant Follicle Stimulating Hormone (rFSH) and Inositol and Melatonin

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Infertility

Intervention ^ICMJE

Drug: Recombinant FSH (rFSH)
225IU
Dietary Supplement: rFSH + Inositol + Melatonin
225IU rFSH, 4g Inositol, 3mg Melatonin

Study Arm (s)

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

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

150

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Female age 18-39 years
BMI 18-30 kg/m2,
Fewer than 3 prior oocyte retrievals,
No fertility Problems

Gender

Female

Ages

18 Years to 39 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

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

Location Countries ^ICMJE

Italy

Administrative Information

NCT Number ^ICMJE

NCT01267604

Other Study ID Numbers ^ICMJE

rFSH-INOPLUS

Has Data Monitoring Committee

Responsible Party

AGUNCO Obstetrics & Gynecology Center

Study Sponsor ^ICMJE

AGUNCO Obstetrics and Gynecology Centre

Collaborators ^ICMJE

University of Modena and Reggio Emilia
Research Center for Reproductive Medicine Villa Mafalda

Investigators ^ICMJE

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

Information Provided By

AGUNCO Obstetrics and Gynecology Centre

Verification Date

December 2010

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

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