Abstract
BackgroundEndometriosis is the major cause of progressive pelvic pain and subfertility. Up to 50% of reproductive-age women suffer from pelvic pain. Endometriosis is a classic indication for IVF. Compared with women whose inability to procreate is caused by simple tubal infertility, women with endometriosis often have lower pregnancy rates following in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI). The administration of gonadotrophin-releasing hormone (GnRH) agonists prior to IVF/ICSI can improve the successful pregnancy rate. Whether a briefer treatment interval would be efficacious has not been studied.Methods/designEligible and consenting women will be randomly assigned to one of two treatments (one cycle of a GnRH agonist or two cycles of a GnRH agonist) prior to IVF/ICSI using a table of random numbers. The primary outcome of this trial is clinical pregnancy rate. Other outcomes include gonadotrophin (Gn) duration, the total dose of follicle-stimulating hormone (FSH) used, number of oocytes retrieved, number of embryos available for transfer, implantation rate, the abortion rate, live birth rate, and incidence of moderate-to-severe ovarian hyperstimulation. The sample size of this trial is estimated to be 421 participants for each of the two arms. Appropriate interim analyses will be conducted by a data monitoring and ethics committee (DMEC), and the final test will be an intention-to-treat analysis.Trial registrationThis trial has been assigned the following registry number: NCT03006406.
Highlights
Endometriosis is the major cause of progressive pelvic pain and subfertility
Up to 50% of reproductive-age women suffer from dysmenorrhea, sexual pain
We aimed to provide a safer and more effective ovulation induction regimen for patients with endometriosis
Summary
Endometriosis is the major cause of progressive pelvic pain and subfertility. Up to 50% of reproductiveage women suffer from pelvic pain. Endometriosis is a classic indication for IVF. Compared with women whose inability to procreate is caused by simple tubal infertility, women with endometriosis often have lower pregnancy rates following in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI). The administration of gonadotrophinreleasing hormone (GnRH) agonists prior to IVF/ICSI can improve the successful pregnancy rate. Endometriosis is defined as the presence of endometriallike tissue outside the uterine cavity. This chronic inflammatory condition is estrogen dependent. Women with pelvic pain identified via endometriosis laparoscopy were followed up; 24–64% of lesions were progressive, and 9– 59% were stable over 12 months [15]. The incidence of endometriosis peaks between 25 and 35 years old, which is the greatest period of reproduction [17]
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