NCT04179253 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Cooper NA, Smith P, Khan KS, Clark TJ
A systematic review of the effect of the distension medium on pain during outpatient hysteroscopy. Fertil Steril. 2011 Jan;95(1):264-71. doi: 10.1016/j.fertnstert.2010.04.080. Epub 2010 Jun 23. Review.
Kowalczyk D, Guzikowski W, Wiecek J, Sioma-Markowska U
Clinical value of real time 3D sonohysterography and 2D sonohysterography in comparison to hysteroscopy with subsequent histopathological examination in perimenopausal women with abnormal uterine bleeding. Neuro Endocrinol Lett. 2012;33(2):212-6.
Molinas CR, Campo R
Office hysteroscopy and adenomyosis. Best Pract Res Clin Obstet Gynaecol. 2006 Aug;20(4):557-67. Epub 2006 Mar 22. Review.
Vaid K, Mehra S, Verma M, Jain S, Sharma A, Bhaskaran S
Pan endoscopic approach "hysterolaparoscopy" as an initial procedure in selected infertile women. J Clin Diagn Res. 2014 Feb;8(2):95-8. doi: 10.7860/JCDR/2014/7271.4018. Epub 2014 Feb 3.

Hysteroscopic Evaluation of Uterine Cavity in Women With Unexplained Infertility

Clinical trial NCT04179253 - References