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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-10

Study Completion Date

2026-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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ICS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Melatonin capsule

Intervention Type DRUG

Participants receive 3mg of Melatonin Capsules

Dosage \& Frequency: Once at night

Duration: The treatment continues for 28 days

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.

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

Participants receive identical-appearing placebo capsule

Dosage \& Frequency: Once at night

Duration: The treatment continues for 28 days

Interventions

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Melatonin capsule

Participants receive 3mg of Melatonin Capsules

Dosage \& Frequency: Once at night

Duration: The treatment continues for 28 days

Intervention Type DRUG

Placebo

Participants receive identical-appearing placebo capsule

Dosage \& Frequency: Once at night

Duration: The treatment continues for 28 days

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes