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

NCT07318974 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2026-01-06

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Benha University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-10
Primary Completion
2026-01-31
Completion
2026-03-31

Countries

  • Egypt

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07318974 on ClinicalTrials.gov