Endometriosis Clinical Trial
Official title:
Effect of Granulocyte Colony-stimulating Factor on Clinical Pregnancy Rate in Patients With Endometriosis Undergoing In-vitro Fertilization After Recurrent Implantation Failure
Verified date | May 2018 |
Source | Ain Shams Maternity Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 88 |
Est. completion date | December 2018 |
Est. primary completion date | October 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 40 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Amira Magdi Guergues Selim |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical pregnancy rate | The primary outcome measure is the clinical pregnancy rate defined as the observation of gestational sac on transvaginal ultrasound examination three weeks after positive serum ßhCG. | 5-6 weeks from the day of embryo transfer | |
Secondary | Chemical pregnancy rate | Positive serum ßhCG test | 12 days after embryo transfer | |
Secondary | Implantation rate | The number of gestational sacs divided by the number of transferred embryos in each group | 6 weeks after embryo transfer | |
Secondary | Ongoing pregnancy rate | The presence of fetal heart activity by ultrasonography after 12 weeks of pregnancy | 12 weeks of pregnancy | |
Secondary | Miscarriage rate | The number of miscarriages before 20 weeks gestation per number of women with positive ßhCG test | Before 20 weeks of pregnancy |
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