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Ovarian Stimulation: Inositol and Melatonin

Primary Purpose

Infertility

Status

Withdrawn

Phase

Phase 4

Locations

Italy

Study Type

Interventional

Intervention

Recombinant FSH (rFSH)

rFSH + Inositol + Melatonin

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

18 Years - 39 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Recombinant FSH

Recombinant FSH Inositol Melatonin

Arm Description

225IU rFSH

225IU rFSH, 4g Inositol and 3mg Melatonin

Outcomes

Primary Outcome Measures

Total oocyte number

Number of clinical pregnancies

Live birth rate

Secondary Outcome Measures

Full Information

NCT ID

NCT01267604

First Posted

December 23, 2010

Last Updated

July 19, 2023

Sponsor

AGUNCO Obstetrics and Gynecology Centre

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT01267604

Brief Title

Ovarian Stimulation: Inositol and Melatonin

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Withdrawn

Study Start Date

December 2010 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AGUNCO Obstetrics and Gynecology Centre

Collaborators

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

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Recombinant FSH

Arm Type

Active Comparator

Arm Description

225IU rFSH

Arm Title

Recombinant FSH Inositol Melatonin

Arm Type

Experimental

Arm Description

225IU rFSH, 4g Inositol and 3mg Melatonin

Intervention Type

Drug

Intervention Name(s)

Recombinant FSH (rFSH)

Intervention Description

225IU

Intervention Type

Dietary Supplement

Intervention Name(s)

rFSH + Inositol + Melatonin

Intervention Description

225IU rFSH, 4g Inositol, 3mg Melatonin

Primary Outcome Measure Information:

Title

Total oocyte number

Time Frame

2 weeks after pharmacological treatment

Title

Number of clinical pregnancies

Time Frame

6 weeks after embryo transfer

Title

Live birth rate

Time Frame

10 months after embryo transfer

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

39 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vittorio Unfer, MD

Organizational Affiliation

AGUNCO Obstetrics and Gynecology Centre

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Gianfranco Carlomagno, PhD

Organizational Affiliation

AGUNCO Obstetrics and Gynecology Centre

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

La Sala Giovanni Battista, MD

Organizational Affiliation

University of Modena and Reggio Emilia

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Franco Lisi, MD

Organizational Affiliation

Research Center for Reproductive Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Modena and Reggio Emilia

City

Reggio Emilia

ZIP/Postal Code

42100

Country

Italy

Facility Name

Research Center for Reproductive Medicine Villa Mafalda

City

Roma

ZIP/Postal Code

00199

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

20712264

Citation

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.

Results Reference

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PubMed Identifier

19800728

Citation

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.

Results Reference

background

PubMed Identifier

18804205

Citation

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.

Results Reference

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Ovarian Stimulation: Inositol and Melatonin

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