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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03549728
Other study ID # 2808
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date June 2018
Est. completion date December 2018

Study information

Verified date May 2018
Source Ain Shams Maternity Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Granulocyte Colony-Stimulating Factor
In group A, at the day of oocyte retrieval, after oocytes collection, 30 mU (300 mcg/0.5 ml) of G-CSF (NeupogenTM, Filgastrim, Amgen Inc., Thousand Oaks, CA, USA) was administered by slow transcervical intrauterine infusion with IUI catheter (AINSEGREY, RIMOS, Italy). In controls, normal saline was used for intrauterine infusion instead of G-CSF.
Procedure:
Intrauterine infusion of normal saline
In group B (controls), normal saline will be used for intrauterine infusion instead of granulocyte colony-stimulating factor on the day of oocyte retrieval.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Amira Magdi Guergues Selim

Outcome

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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