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NCT02993588 Clinical Trial

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

In Vitro Fertilization Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02993588
Other study ID # Melatonin RCT
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received December 13, 2016
Last updated December 14, 2016
Start date December 2016

Study information
Verified date December 2016
Source Assiut University
Contact Osama Abdalmageed, MD
Phone 1007972027
Email drosamast1981@gmail.com
Is FDA regulated No
Health authority Egypt: Ministry of Higher Education
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date
Est. primary completion date August 2017
Accepts healthy volunteers No
Gender Female
Age group 30 Years to 42 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Severe male factor infertility.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Melatonin
Melatonin 6 mg tablet once daily
Other:
• Placebo
one tablet once daily

Locations
Country Name City State
Egypt Osama Abdalmageed Assiut Non-US/Non-Canadian
Egypt Osama Abdalmageed Assiut

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & 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. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Total number of retrieved mature oocytes On the day of oocyte retrieval procedure No
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