ICS
Conditions
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.
Interventions
Participants receive 3mg of Melatonin Capsules Dosage & Frequency: Once at night Duration: The treatment continues for 28 days
DRUGPlacebo
Participants receive identical-appearing placebo capsule Dosage & Frequency: Once at night Duration: The treatment continues for 28 days
Sponsors
Benha University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Success Rate of Treatment Regimens in Achieving Clinical Pregnancy | 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. |
Countries
Egypt
Outcome results
None listed