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

Benha University

Status and phase: Active, not recruiting; Phase 2

Conditions: ICS

Treatments: Drug: Placebo; Drug: Melatonin capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT07318974

Rc 2.8.2025

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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64 participants in 2 patient groups

Melatonin Group

Active Comparator group

Description:

Participants receive one 3 mg Melatonin capsule orally every night for 28 consecutive days prior to the start of ovarian stimulation for ICSI.

Treatment:

Drug: Melatonin capsule

Placebo Group

Active Comparator group

Description:

Participants receive an identical-appearing placebo capsule orally every night for 28 consecutive days prior to the start of ovarian stimulation for ICSI.

Treatment:

Drug: Placebo