NCT03549728.

Study name	Effect of granulocyte colony‐stimulating factor on clinical pregnancy rate in patients with endometriosis undergoing in vitro fertilization after recurrent implantation failure
Methods	Allocation: randomised Intervention model: parallel assignment Masking: triple (participant, care provider, investigator)
Participants	A total of 88 women with endometriosis will be enrolled in the study divided into 2 groups, as follows. Group A (N = 44): women will receive intrauterine infusion of G‐CSF on the day of ovum‐pick up during IVF cycle Group B (N = 44): women will receive placebo intrauterine infusion of saline on the day of ovum‐pick up during IVF cycle Inclusion criteria: Cases of infertility, older than 20 years of age and not older than 40 years Body mass index: 20 to 29 Women diagnosed with endometriosis (diagnosis based on ultrasound or laparoscopy or both) Recurrent implantation failure (failure to conceive following 2 embryo transfer cycles, or cumulative transfer of > 10 good‐quality embryos) Normal ovulatory cycles (as proven by folliculometry and/or mid‐luteal serum progesterone), good ovarian reserve (as proven by early follicular FSH and AMH) Normal uterine cavity as assessed by ultrasonography, hysterosalpingography, or hysteroscopy Normal hormonal profile (serum PRL, TSH, thyroid hormone) Normal semen analysis of the partner Infertility after 1 year of unprotected intercourse High‐quality embryos were transplanted Exclusion criteria: Congenital or acquired uterine abnormalities (e.g. septate, bicornuate, fibroid uterus, uterine polyp and Asherman syndrome) Congenital or acquired tubal abnormalities (e.g. hydrosalpinx or pyosalpinx) Contraindication for G‐CSF (renal disease, sickle cell disease, malignancy history, upper respiratory tract infection, pneumonia, or chronic neutropenia) Thrombophilia
Interventions	Experimental: Group A Group A (N = 44): women will receive intrauterine infusion of G‐CSF on the day of ovum‐pick up during IVF cycle Placebo comparator: Group B Group B (N = 44): women will receive placebo intrauterine infusion of normal saline on the day of ovum‐pick up during IVF cycle
Outcomes	Primary outcome : Clinical pregnancy rate [ Time Frame: 5 to 6 weeks from the day of embryo transfer ] Secondary outcome : Chemical pregnancy rate [ Time Frame: 12 days after embryo transfer ] Implantation rate [ Time Frame: 6 weeks after embryo transfer ] Ongoing pregnancy rate [ Time Frame: 12 weeks of pregnancy ] Miscarriage rate [ Time Frame: before 20 weeks of pregnancy ]
Starting date	June 2018
Contact information	Location: Cairo, Egypt Contact: Amira Magdi Guergues Selim, Resident of obstetrics and gynaecology, Ain Shams Maternity Hospital. No email address available on website.
Notes	Recruitment status: not yet recruiting Estimated study completion date: December 2018 Study sponsor: Ain Shams Maternity Hospital

PRL: prolactin
TSH: thyroid stimulating hormone