Effect of Granulocyte Colony-stimulating Factor on Clinical Pregnancy Rate in Patients With Endometriosis

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The aim of this study is to evaluate the effect of granulocyte colony-stimulating factor on clinical pregnancy rate in patients with endometriosis undergoing in-vitro fertilization after recurrent implantation failure.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amira Magdi Guergues Selim
• Treatments: Lenograstim; Sargramostim

Criteria

Inclusion Criteria:

• Cases of infertility, older than 20 years of age and not older than 40 years.

• Body mass index (BMI): 20-29.

• Women diagnosed with endometriosis (diagnosis based on ultrasound or laparoscopy or both)

• Recurrent implantation failure (failure to conceive following two embryo transfer cycles, or cummulative 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 one year of unprotected intercourse

• High-quality embryos were transplanted

Exclusion Criteria:

• Congenital or acquired uterine abnormalities (e.g. septate, bicornuate, fibroid uterus, uterine polyp & Asherman Syndrome)

• Congenital or acquired tubal abnormalities (e.g. hydrosalpinx or pyosalpinx)

• Contraindication for G-CSF (renal disease, sickle cell disease, or malignancy history, upper respiratory tract infection, pneumonia, or chronic neutropenia)

• Thrombophilia