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
• 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. 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

• In Vitro Fertilization
• Poor Ovarian Response

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