The relationship between serum progesterone level on the day of human chorionic gonadotropin administration and outcome of in vitro fertilization /intracytoplasmic sperm injection and embryo transfer has been controversial for several decades. some studies presented data against the negative effect of premature luteinization and reported that elevated serum progesterone had no adverse effect on pregnancy rates in fresh embryo-transfer cycles within different ovarian responses. However, most studies have evaluated the association between serum progesterone level and clinical outcome in fresh in vitro fertilization /intracytoplasmic sperm injection cycles and advocated that serum progesterone elevation on the day of human chorionic gonadotropin administration may adversely affect the clinical outcome by jeopardizing endometrial receptivity. In addition, the underlying mechanism through which premature luteinization influences clinical outcomes is elusive. some proposed that premature luteinization cause impairment of the endometrial receptivity, which may indicate a change in the implantation window, is more likely to be affected than the oocyte.whereas some documented that the compromised quality of oocytes might also be a cause. The cut-off point of premature luteinization is not well established until now. Premature luteinization has been variously defined based on serum P levels, with thresholds of 0.9-1.5 ng/mL being used. Previous studies have shown that metformin inhibits the first steps of steroidogenesis dose-dependently reducing granulosa cells progesterone output. Moreover, other authors have recently reported that low dose metformin could improve in vitro fertilization outcome in non poly-cystic ovarian syndrome repeaters. So, considering the safety of this drug before pregnancy, metformin can be given to consenting patients from first ultrasound monitoring until ovulation triggering.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
320
Women Health Hospital - Assiut university
Asyut, Egypt
Incidence of premature luteinization in both groups
Serum progesterone measurement ≥ 1.5 ng/ml by Mini-vidas assay was used to diagnose cases of premature luteinization.
Time frame: 12 days
ongoing pregnancy rate
The number of cases with pregnancy more than 12 weeks of gestation divided by the cycles initiated per 100.
Time frame: 12 weeks
Good quality embryo rate
The number of good day 3 embryos per all two-pronuclear embryos.
Time frame: 20 days
Progesterone-to-mature oocyte index (PMOI)
calculated by dividing the serum P level (ng/ml) by the number of mature oocytes.
Time frame: 17 days
Progesterone/estradiol ratio
calculated as \[progesterone (ng/mL) × 1000\]/esatradiol (pg/mL)
Time frame: 12 days
Implantation rate
The number of gestational sacs observed by trans-vaginal ultrasound divided by the number of embryos transferred.
Time frame: 7 weeks
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