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

NCT ID: NCT02993588

Last Updated: 2016-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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In Vitro Fertilization Poor Ovarian Response

Keywords

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Melatonin IVF/ICSI Poor ovarian response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Melatonin

Melatonin 6 mg tablet once daily.

Group Type EXPERIMENTAL

Melatonin

Intervention Type DRUG

Melatonin 6 mg tablet once daily

Placebo

Placebo tablet once daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

one tablet once daily

Interventions

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Melatonin

Melatonin 6 mg tablet once daily

Intervention Type DRUG

Placebo

one tablet once daily

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Severe male factor infertility.
Minimum Eligible Age

30 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Osama Saber Thabet Abdalmageed

Lecturer of OBGYN, Women Health Hospital, Assiut Univerisity

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Osama Abdalmageed, MD

Role: PRINCIPAL_INVESTIGATOR

Women health center

Locations

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Osama Abdalmageed

Asyut, Asyut Governorate, Egypt

Site Status RECRUITING

Osama Abdalmageed

Asyut, Non-US/Non-Canadian, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Osama Abdalmageed, MD

Role: CONTACT

Phone: 1007972027

Email: [email protected]

Osama Abdalmageed, MD

Role: CONTACT

Phone: 882102204

Email: [email protected]

Facility Contacts

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Osama Abdalmageed

Role: primary

Osama Abdalmageed

Role: backup

Osama Abdalmageed, MD

Role: primary

Osama Abdalmageed

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 25330986 (View on PubMed)

Other Identifiers

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Melatonin RCT

Identifier Type: -

Identifier Source: org_study_id