NCT07318974

Melatonin Therapy for Improving ICSI Outcomes in Women With Diminished Ovarian Reserve

Preliminary Assessment of the Impact of Melatonin Therapy for Women With Diminished Ovarian Reserve on the Ovarian Reserve and the ICSI Outcomes

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Benha University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Diminished ovarian reserve (DOR) is a major challenge in female fertility, often leading to poor oocyte quality and low pregnancy rates during assisted reproduction. Melatonin is a potent antioxidant that may protect developing eggs from oxidative stress. This randomized clinical trial aims to evaluate whether a 4-week course of oral melatonin therapy before egg retrieval can improve the quality of oocytes and embryos, and ultimately increase pregnancy rates for women with DOR undergoing Intracytoplasmic Sperm Injection (ICSI). The study compares melatonin therapy against a placebo to assess its impact on follicular fluid health and clinical pregnancy success.

Conditions

• ICS

Interventions

Type	Name	Description
DRUG	Melatonin capsule	Participants receive 3mg of Melatonin Capsules Dosage \& Frequency: Once at night Duration: The treatment continues for 28 days
DRUG	Placebo	Participants receive identical-appearing placebo capsule Dosage \& Frequency: Once at night Duration: The treatment continues for 28 days

Timeline

• Start date: 2025-09-10
• Primary completion: 2026-01-01
• Completion: 2026-03-01
• First posted: 2026-01-06
• Last updated: 2026-01-06

Locations

1 site across 1 country: Egypt