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

Assiut University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: In Vitro Fertilization; Poor Ovarian Response

Treatments: Other: Placebo; Drug: Melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT02993588

Melatonin RCT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 30 to 42 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Severe male factor infertility.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Melatonin

Experimental group

Description:

Melatonin 6 mg tablet once daily.

Treatment:

Drug: Melatonin

Placebo

Placebo Comparator group

Description:

Placebo tablet once daily

Treatment:

Other: Placebo