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

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ClinicalTrials.gov Identifier: NCT03549728
Recruitment Status : Not yet recruiting
First Posted : June 8, 2018
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
Amira Magdi Guergues Selim, Ain Shams Maternity Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Recurrent Implantation Failure Endometriosis Drug: Granulocyte Colony-Stimulating Factor Procedure: Intrauterine infusion of normal saline Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arm Intervention/treatment
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.
Other Names:
  • Neupogen
  • Filgrastim

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 :
  1. 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 :
  1. Chemical pregnancy rate [ Time Frame: 12 days after embryo transfer ]
    Positive serum βhCG test

  2. Implantation rate [ Time Frame: 6 weeks after embryo transfer ]
    The number of gestational sacs divided by the number of transferred embryos in each group

  3. Ongoing pregnancy rate [ Time Frame: 12 weeks of pregnancy ]
    The presence of fetal heart activity by ultrasonography after 12 weeks of pregnancy

  4. 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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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Chromosomally 46XX
Accepts Healthy Volunteers:   No
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

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Responsible Party: Amira Magdi Guergues Selim, Resident of obstetrics and gynecology, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier: NCT03549728     History of Changes
Other Study ID Numbers: 2808
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Amira Magdi Guergues Selim, Ain Shams Maternity Hospital:
endometriosis
granulocyte colony-stimulating factor
recurrent implantation failure

Additional relevant MeSH terms:
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Endometriosis
Genital Diseases, Female
Sargramostim
Lenograstim
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic