Impact of Melatonin on IVF/ICSI Outcomes in Prospective P... | NCT02993588

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

NCT02993588

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Dec 15, 2016Estimated

Enrollment

100Estimated

Phase

Phase 2Phase 3

Conditions

In Vitro Fertilization
Poor Ovarian Response

Interventions

Melatonin
Placebo

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2016

Primary Completion Date

Aug 2017Estimated

Completion Date

Not provided

First Submitted Date

Dec 13, 2016

First Submission Date that Met QC Criteria

Dec 14, 2016

First Posted Date

Dec 15, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 14, 2016

Last Update Posted Date

Dec 15, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Osama Saber Thabet Abdalmageed, Lecturer of OBGYN, Women Health Hospital, Assiut Univerisity, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Melatonin	Experimental	Melatonin 6 mg tablet once daily.	Drug: Melatonin
Placebo	Placebo Comparator	Placebo tablet once daily	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Melatonin	Drug	Melatonin 6 mg tablet once daily	Melatonin
Placebo

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Severe male factor infertility.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

42 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Osama Abdalmageed, MD	Contact	1007972027		drosamast1981@gmail.com
Osama Abdalmageed, MD	Contact	882102204		drosamast1981@gmail.com

Overall Officials

Name	Affiliation	Role
Osama Abdalmageed, MD	Women health center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Osama Abdalmageed	Recruiting	Asyut	Asyut Governorate	71515	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25330986	Background	Fernando S, Rombauts L. Melatonin: shedding light on infertility?--A review of the recent literature. J Ovarian Res. 2014 Oct 21;7:98. doi: 10.1186/s13048-014-0098-y.

ID	Term
D014363	Tryptamines
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring