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

Phase 2

• Conditions: In Vitro Fertilization; Poor Ovarian Response
• Interventions: Drug: Melatonin; Other: Placebo

• Registration Number: NCT02993588
• Lead Sponsor: Assiut University

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.

Study Timeline

• Status Verified: 2016-12
• Study Start: 2016-12
• Study First Submitted: 2016-12-13
• Study First Submitted QC: 2016-12-14
• Last Update Submitted: 2016-12-14
• Study First Posted: 2016-12-15
• Last Update Posted: 2016-12-15
• Primary Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

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

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Exclusion Criteria

• Severe male factor infertility.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Melatonin	Melatonin	Melatonin 6 mg tablet once daily.
Placebo	Placebo	Placebo tablet once daily

Primary Outcome Measures

Name	Time	Method
Total number of retrieved mature oocytes	On the day of oocyte retrieval procedure

Trial Locations

Locations (1)

Osama Abdalmageed; 🇪🇬 Assiut, Egypt