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

NCT07318974 | Active Not Recruiting Phase 2

• 1 other identifier: Rc 2.8.2025
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• The Success Rate of Treatment Regimens in Achieving Clinical Pregnancy

  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

Study Arms (2)

Melatonin Group

ACTIVE COMPARATOR

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

Placebo Group

ACTIVE COMPARATOR

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

Interventions

Melatonin capsule DRUG

Participants receive 3mg of Melatonin Capsules Dosage \& Frequency: Once at night Duration: The treatment continues for 28 days

Melatonin Group

Placebo DRUG

Participants receive identical-appearing placebo capsule Dosage \& Frequency: Once at night Duration: The treatment continues for 28 days

Placebo Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha university

Banhā, El Qalyoubia, 13511, Egypt

Location

MeSH Terms

Interventions

Melatonin

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics & Gynecology, Faculty of Medicine, Benha University

Study Record Dates

• First Submitted: December 21, 2025
• First Posted: January 6, 2026
• Study Start: September 10, 2025
• Primary Completion: January 1, 2026
• Study Completion: March 1, 2026
• Last Updated: January 6, 2026

Record last verified: 2025-12

Locations

EG (1)