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NCT Number: NCT07318974

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

ICS

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Benha university

Banhā, El Qalyoubia, 13511, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Melatonin capsule

Drug

Participants receive 3mg of Melatonin Capsules

Dosage & Frequency: Once at night

Duration: The treatment continues for 28 days

Placebo

Drug

Participants receive identical-appearing placebo capsule

Dosage & Frequency: Once at night

Duration: The treatment continues for 28 days

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 6, 2026
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.