Effect of Granulocyte Colony-stimulating Factor on Clinical Pregnancy Rate in Patients With Endometriosis
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|ClinicalTrials.gov Identifier: NCT03549728|
Recruitment Status : Unknown
Verified May 2018 by Amira Magdi Guergues Selim, Ain Shams Maternity Hospital.
Recruitment status was: Not yet recruiting
First Posted : June 8, 2018
Last Update Posted : June 8, 2018
Amira Magdi Guergues Selim
Information provided by (Responsible Party):
Amira Magdi Guergues Selim, Ain Shams Maternity Hospital
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.
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Implantation Failure Endometriosis||Drug: Granulocyte Colony-Stimulating Factor Procedure: Intrauterine infusion of normal saline||Phase 2|
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|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||88 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||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.|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||: Eighty eight envelopes will be numbered serially and in each envelope the corresponding letter which denotes the allocated group will be put according to randomization table. When the first patient arrives, the first envelope will be opened and the patient will be allocated according to the letter inside into group A or B|
|Primary Purpose:||Supportive Care|
|Official Title:||Effect of Granulocyte Colony-stimulating Factor on Clinical Pregnancy Rate in Patients With Endometriosis Undergoing In-vitro Fertilization After Recurrent Implantation Failure|
|Estimated Study Start Date :||June 2018|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Group A
Group A (N=44): women will receive intrauterine infusion of granulocyte colony-stimulating factor on the day of ovum-pick up during IVF cycle.
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.
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.
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.
Primary Outcome Measures :
- Clinical pregnancy rate [ Time Frame: 5-6 weeks from the day of embryo transfer ]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 βhCG.
Secondary Outcome Measures :
- Chemical pregnancy rate [ Time Frame: 12 days after embryo transfer ]Positive serum βhCG test
- Implantation rate [ Time Frame: 6 weeks after embryo transfer ]The number of gestational sacs divided by the number of transferred embryos in each group
- Ongoing pregnancy rate [ Time Frame: 12 weeks of pregnancy ]The presence of fetal heart activity by ultrasonography after 12 weeks of pregnancy
- Miscarriage rate [ Time Frame: Before 20 weeks of pregnancy ]The number of miscarriages before 20 weeks gestation per number of women with positive βhCG test
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