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

December 21, 2025 updated by: Basma Sakr, Benha University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • El Qalyoubia
      • Banhā, El Qalyoubia, Egypt, 13511
        • Benha University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Confirmed Diminished Ovarian Reserve (DOR) based on Bologna criteria (e.g., low AMH, low AFC).
  • Undergoing ICSI with frozen blastocyst transfer (FBT) protocol.
  • Willingness to comply with a 28-day pre-retrieval medication regimen.

Exclusion Criteria:

  • Severe endometriosis or hydrosalpinx.
  • Uterine anomalies (e.g., large fibroids or uterine septums).
  • Chronic systemic diseases (e.g., uncontrolled diabetes or hypertension).
  • Partner with severe male factor infertility requiring TESE/PESA (to isolate the effect on oocyte quality).
  • Current use of other antioxidant supplements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Melatonin Group
Participants receive one 3 mg Melatonin capsule orally every night for 28 consecutive days prior to the start of ovarian stimulation for ICSI.
Drug: Melatonin capsule

Participants receive 3mg of Melatonin Capsules

Dosage & Frequency: Once at night

Duration: The treatment continues for 28 days
Active Comparator: Placebo Group
Participants receive an identical-appearing placebo capsule orally every night for 28 consecutive days prior to the start of ovarian stimulation for ICSI.
Drug: Placebo

Participants receive identical-appearing placebo capsule

Dosage & Frequency: Once at night

Duration: The treatment continues for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Success Rate of Treatment Regimens in Achieving Clinical Pregnancy
Time Frame: 2-3 Months
The proportion of patients who achieved a clinical pregnancy (confirmed by ultrasound visualization of a gestational sac with fetal heart activity) following frozen blastocyst transfer, reflecting the effectiveness of the administered melatonin therapy.
2-3 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

December 21, 2025

First Submitted That Met QC Criteria

December 21, 2025

First Posted (Actual)

January 6, 2026

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

December 21, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rc 2.8.2025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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