Infertile Women Undergoing IVF or ICSI, Infertility, Infertility (IVF Patients)
Conditions
Keywords
IVF, Infertile women, Melatonin, follicular fluid, ovarian response
Brief summary
Melatonin is a potent antioxidant, has been proposed to improve ovarian response and oocyte quality in assisted reproductive technologies (ART). This study evaluated the effects of melatonin supplementation on follicular fluid melatonin levels, hormonal profiles, and reproductive outcomes in women undergoing in vitro fertilization (IVF). Follicular fluid and serum melatonin levels, oocyte quality, embryo development, and pregnancy rates were assessed.
Detailed description
Background: Melatonin, a potent antioxidant, has been proposed to improve ovarian response and oocyte quality in assisted reproductive technologies (ART). This study evaluated the effects of melatonin supplementation on follicular fluid melatonin levels, hormonal profiles, and reproductive outcomes in women undergoing in vitro fertilization (IVF). Methods: In this double-blind, randomized controlled trial, 80 infertile women were allocated to receive either 5 mg melatonin nightly (n=40) or placebo (n=40) during ovarian stimulation. Follicular fluid and serum melatonin levels, oocyte quality, embryo development, and pregnancy rates were assessed. Statistical analyses included Mann-Whitney U tests for continuous variables and chi-square/Fisher's tests for categorical data.
Interventions
DRUG5mg melatonin supplementation
5 mg melatonin suplementation
OTHERSham (No Treatment)
Sham (no treatment)
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Infertile women aged 18-40 years * No previous infertility treatment * No previous hormonal treatment * No previous radio-chemotherapy treatment
Exclusion criteria
* Fertile women * Previous hormonal treatment * Previous radio-chemotherapy treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Follicular fluid melatonin concentration | Baseline (pre-intervention), periprocedurally and in the end of treatment at 7 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reprodutive outcomes | From the enrollment to the end of treatment at 7 weeks | (1) oocyte maturation rate (MII/oocytes retrieved), (2) blastocyst formation rate, (3) implantation rate (gestational sacs per embryo transferred), and (4) clinical pregnancy rate (ultrasound-confirmed at 7 weeks). |
Countries
Brazil
Outcome results
None listed