Impact of Melatonin on IVF/ICSI Outcomes in Prospective Poor Responders

December 14, 2016 updated by: Osama Saber Thabet Abdalmageed, Assiut University

Impact of Melatonin Adjuvant Therapy on IVF/ICSI Outcomes in Prospective Poor Responders: A Double-blind, Randomized, Placebo-controlled Trial

The purpose of this study is to investigate the impact of melatonin administration on in vitro fertilization (IVF/ICSI) outcomes namely the total number and quality of the oocytes and embryos in the prospective poor responders.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The prospective poor responders have been associated with lower number and poorer oocyte quality. Melatonin is suggested to have antioxidative effects which may contribute to improving the IVF/ICSI outcomes in this group of patients who expected to have poor outcomes. However, the expected beneficial effects of melatonin have not yet been investigated. The purpose of this study is to investigate the impact of melatonin administration on IVF/ICSI outcomes namely the total number and quality of the oocytes and embryos in the prospective poor responders. A randomized, double-blinded, placebo-controlled study is used to investigate the impact of melatonin on the IVF/ICSI outcomes.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

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

Study Locations

  • Egypt
      • Assiut, Egypt, 71515
        • Recruiting
        • Osama Abdalmageed
        • Contact:
        • Contact:
          • Osama Abdalmageed
          • Phone Number: Abdalmageed 1007972027
    • Non-US/Non-Canadian
      • Assiut, Non-US/Non-Canadian, Egypt, 71111

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

26 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Prospective poor responder with AMH < 1 ng/ml and AFC < 8 (in both ovaries).

Exclusion Criteria:

  • Severe male factor infertility.

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
Placebo Comparator: Placebo
Placebo tablet once daily
Other: Placebo
one tablet once daily
Experimental: Melatonin
Melatonin 6 mg tablet once daily.
Drug: Melatonin
Melatonin 6 mg tablet once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total number of retrieved mature oocytes
Time Frame: On the day of oocyte retrieval procedure
On the day of oocyte retrieval procedure

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Principal Investigator: Osama Abdalmageed, MD, Women Health Center

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, 2016

Primary Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

December 13, 2016

First Submitted That Met QC Criteria

December 14, 2016

First Posted (Estimate)

December 15, 2016

Study Record Updates

Last Update Posted (Estimate)

December 15, 2016

Last Update Submitted That Met QC Criteria

December 14, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Melatonin RCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The data will be kept with the study team only and it is not allowed by our institution regulations to share the data.

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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