To assess the effect of oral melatonin administration on clinical outcomes in women undergoing in-vitro fertilisation (IVF)
Phase 2
- Conditions
- infertility.female infertility
- Registration Number
- IRCT2015042912307N4
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 90
Inclusion Criteria
Age 18-40 yrs.; normal level of serum steroidal hormones; agonist long protocol of controlled ovarian stimulation; male factor; tubal factor; and unexplained infertility.
Exclusion Criteria
Myoma; a congenital uterine anomaly; use of estrogens; progesterone; androgens; or chronic use of any medication; including nonsteroidal anti-inflammatory agents or anticonvulsants, smoking; severe endometriosis.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The degenerate oocyte counts. Timepoint: oocyte pick up day. Method of measurement: Microscopic assay.;The fertilization rate. Timepoint: 24 hours after ICSI. Method of measurement: Microscopic assay.;The embryo quality. Timepoint: 24 hours after ICSI. Method of measurement: Microscopic assay.;The mean number of the oocytes. Timepoint: oocyte pick up day. Method of measurement: Microscopic assay.;The mean metaphase II (MII) oocyte counts. Timepoint: oocyte pick up day. Method of measurement: Microscopic assay.
- Secondary Outcome Measures
Name Time Method MRNA level of MT-ATP6 gene incumulus cells. Timepoint: after sampling. Method of measurement: q-PCR.;The biochemical pregnancy rate. Timepoint: 2 weeks after embryo transfer. Method of measurement: ??Serum B.hCG titter.