Ovarian Stimulation: Inositol and Melatonin

July 19, 2023 updated by: AGUNCO Obstetrics and Gynecology Centre

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Reggio Emilia, Italy, 42100
        • University of Modena and Reggio Emilia
      • Roma, Italy, 00199
        • Research Center for Reproductive Medicine Villa Mafalda

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total oocyte number
Time Frame: 2 weeks after pharmacological treatment
2 weeks after pharmacological treatment
Number of clinical pregnancies
Time Frame: 6 weeks after embryo transfer
6 weeks after embryo transfer
Live birth rate
Time Frame: 10 months after embryo transfer
10 months after embryo transfer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AGUNCO Obstetrics and Gynecology Centre

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

December 23, 2010

First Submitted That Met QC Criteria

December 27, 2010

First Posted (Estimated)

December 28, 2010

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rFSH-INOPLUS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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