Effect of Metformin on Premature Luteinization and Pregnancy Outcomes in Intracytoplasmic Sperm Injection-Fresh Embryo Transfer Cycles: A Randomized Double-Blind Controlled Trial
نویسندگان
1 Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt
2 Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt
3 Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt
4 Department of Obstetrics and Gynecology, Mayo Clinic, Rochester, Minnesota, USA
5 Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt
6 Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt
7 Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt
8 Department of Obstetrics and Gynecology, Mayo Clinic, Rochester, Minnesota, USA
9 Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt
10 Department of Obstetrics and Gynecology, Taibah University, Medina, KSA
11 Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt
12 Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt
doi
10.22074/ijfs.2020.134643چکیده
Background: Premature luteinization (PL) is not unusual in in vitro fertilization (IVF) and could not be whollyavoided by using either gonadotropin-releasing hormone (GnRH) agonists or GnRH antagonist regimens. The studyaims to evaluate metformin’s efficacy in preventing PL in fresh GnRH antagonist intracytoplasmic sperm injection(ICSI) cycles with cleavage-stage embryo transfer.Materials and Methods: This randomized, double-blind, placebo-controlled trial was conducted in a tertiary universityIVF center. We recruited infertile women who were scheduled to perform their first or second ICSI trial. Eligiblewomen were recruited and randomized in a 1:1 ratio into two groups. Metformin was administered in a dose of 1500mg per day since the start of contraceptive pills in the cycle antecedent to stimulation cycle until the day of ovulationtriggering, while women in the placebo group received a placebo for the same regimen and duration. The primaryoutcome was the incidence of PL, defined as serum progesterone (P) on the triggering day ≥1.5 ng/mL. Secondaryoutcomes comprised the live birth, ongoing pregnancy, implantation, and good-quality embryos rates.Results: The trial involved 320 eligible participants (n=160 in each group). Both groups had comparable stimulationdays, endometrial thickness, peak estradiol levels, number of oocytes retrieved, and number of mature oocytes. Metformingroup experienced lower level of serum P (p <0.001) and incidence of PL (10 vs. 23.6%, P=0.001). Moreover,lower progesterone/estradiol (P/E) ratio and progesterone to mature oocyte index (PMOI) (P=0.002 and P=0.002,respectively) were demonstrated in women receiving metformin. Metformin group generated a better rate of goodqualityembryos (P=0.005) and ongoing pregnancy (43.8 vs. 31.8%, P=0.026). A similar trend, though of borderlinesignificance, was observed in the live birth rate in favor of metformin administration (38.15 vs. 27.5%, P=0.04).Conclusion: Metformin could be used in patients with potential PL to improve fresh cycle outcomes by preventing PL(Registration number: NCT03088631).
