NCT02993588

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 15, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Last Updated

December 15, 2016

Status Verified

December 1, 2016

Enrollment Period

8 months

First QC Date

December 13, 2016

Last Update Submit

December 14, 2016

Conditions

In Vitro FertilizationPoor Ovarian Response

Keywords

MelatoninIVF/ICSIPoor ovarian response

Outcome Measures

Primary Outcomes (1)

  • Total number of retrieved mature oocytes

    On the day of oocyte retrieval procedure

Study Arms (2)

Melatonin

EXPERIMENTAL

Melatonin 6 mg tablet once daily.

Drug: Melatonin

Placebo

PLACEBO COMPARATOR

Placebo tablet once daily

Other: Placebo

Interventions

MelatoninDRUG

Melatonin 6 mg tablet once daily

Melatonin
PlaceboOTHER

one tablet once daily

Placebo

Eligibility Criteria

Age30 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Severe male factor infertility.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Osama Abdalmageed

Asyut, Asyut Governorate, 71515, Egypt

RECRUITING

Osama Abdalmageed

Asyut, Non-US/Non-Canadian, 71111, Egypt

RECRUITING

Related Publications (1)

  • 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.

    PMID: 25330986BACKGROUND

MeSH Terms

Interventions

Melatonin

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Osama Abdalmageed, MD

    Women health center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Osama Abdalmageed, MD

CONTACT

1007972027drosamast1981@gmail.com

Osama Abdalmageed, MD

CONTACT

882102204drosamast1981@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of OBGYN, Women Health Hospital, Assiut Univerisity

Study Record Dates

First Submitted

December 13, 2016

First Posted

December 15, 2016

Study Start

December 1, 2016

Primary Completion

August 1, 2017

Last Updated

December 15, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

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

Locations

EG(2)