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

NCT03549728 | Unknown Phase 2

• 1 other identifier: 2808
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Recurrent Implantation Failure; Endometriosis

Keywords

endometriosis; granulocyte colony-stimulating factor; recurrent implantation failure

Outcome Measures

Primary Outcomes (1)

• 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 βhCG.

  5-6 weeks from the day of embryo transfer

Secondary Outcomes (4)

• Chemical pregnancy rate

  12 days after embryo transfer

• Implantation rate

  6 weeks after embryo transfer

• Ongoing pregnancy rate

  12 weeks of pregnancy

• Miscarriage rate

  Before 20 weeks of pregnancy

Study Arms (2)

Group A

EXPERIMENTAL

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

Group B

PLACEBO COMPARATOR

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

Interventions

Granulocyte Colony-Stimulating Factor DRUG

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.

Also known as: Neupogen, Filgrastim

Group A

Intrauterine infusion of normal saline PROCEDURE

In group B (controls), normal saline will be used for intrauterine infusion instead of granulocyte colony-stimulating factor on the day of oocyte retrieval.

Group B

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: Chromosomally 46XX
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amira Magdi Guergues Selim: lead

MeSH Terms

Conditions

Endometriosis

Interventions

Granulocyte Colony-Stimulating Factor; Filgrastim

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: : 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
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident of obstetrics and gynecology

Model Details: 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.

Study Record Dates

• First Submitted: May 26, 2018
• First Posted: June 8, 2018
• Study Start: June 1, 2018
• Primary Completion: October 1, 2018
• Study Completion: December 1, 2018
• Last Updated: June 8, 2018

Record last verified: 2018-05