NCT03380364

Brief Summary

The aim of this work is to assess the value of hysteroscopy in unexplained infertility.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 21, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

April 3, 2018

Status Verified

April 1, 2018

Enrollment Period

1.7 years

First QC Date

December 17, 2017

Last Update Submit

April 1, 2018

Conditions

Unexplained Infertility

Outcome Measures

Primary Outcomes (1)

  • Pregnancy

    Biochemical and clinical Pregnancy Biochemical pregnancy will be determined by a positive pregnancy test performed 1week after a missed period and clinical pregnancy will be defined by the presence of a gestational sac using transvaginal ultrasound performed 6 weeks after a missed period.

    6 months

Study Arms (1)

Group Undergoing Hysterosopy

EXPERIMENTAL

This group will include 75 women with unexplained infertility. 5 mm rigid sheath Office hysteroscopy will be performed during the proliferative phaseof the menstrual cycle.

Device: hystroscope

Interventions

hystroscopeDEVICE

Procedure: Hysteroscopy Office hysteroscopy will be performed during the proliferative phaseof the menstrual cycle. All OH (office hysteroscopy) procedures will be performed with a vaginoscopic approach without utilizing a speculum and applying traction to the cervix with a tenaculum. Antibiotic prophylaxis: None OH will be cancelled until after treatment of vaginal infection. Other Name: ROH: Routine Office Hysteroscopy Device: Hysteroscope The device used is a rigid hysteroscope (continuous flow, 30 degree forward oblique view) assembled in a 5-mm diameter diagnostic rigid sheath with an atraumatic tip (Karl Storz Endoscopy). Illumination: High intensity cold light source and fiberoptic cable Distention medium: solution of 0.9% normal saline with pressure at 100-120 mmHg

Group Undergoing Hysterosopy

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \. All women aged (20-35) years old. 2. Unexplained infertility

You may not qualify if:

  • \. Female genital tract cancer, including cervical or uterine cancer 2. Active pelvic infection 3. Known uterine factor for infertility.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of obstetrics and gynaecology, faculty of medicine, Ain shams university

Cairo, 11591, Egypt

RECRUITING

Related Publications (18)

  • Aydeniz B, Gruber IV, Schauf B, Kurek R, Meyer A, Wallwiener D. A multicenter survey of complications associated with 21,676 operative hysteroscopies. Eur J Obstet Gynecol Reprod Biol. 2002 Sep 10;104(2):160-4. doi: 10.1016/s0301-2115(02)00106-9.

    PMID: 12206931RESULT

  • Chan YY, Jayaprakasan K, Zamora J, Thornton JG, Raine-Fenning N, Coomarasamy A. The prevalence of congenital uterine anomalies in unselected and high-risk populations: a systematic review. Hum Reprod Update. 2011 Nov-Dec;17(6):761-71. doi: 10.1093/humupd/dmr028. Epub 2011 Jun 24.

    PMID: 21705770RESULT

  • Chan YY, Jayaprakasan K, Tan A, Thornton JG, Coomarasamy A, Raine-Fenning NJ. Reproductive outcomes in women with congenital uterine anomalies: a systematic review. Ultrasound Obstet Gynecol. 2011 Oct;38(4):371-82. doi: 10.1002/uog.10056.

    PMID: 21830244RESULT

  • Fatemi HM, Kasius JC, Timmermans A, van Disseldorp J, Fauser BC, Devroey P, Broekmans FJ. Prevalence of unsuspected uterine cavity abnormalities diagnosed by office hysteroscopy prior to in vitro fertilization. Hum Reprod. 2010 Aug;25(8):1959-65. doi: 10.1093/humrep/deq150. Epub 2010 Jun 22.

    PMID: 20570971RESULT

  • Grimbizis GF, Camus M, Tarlatzis BC, Bontis JN, Devroey P. Clinical implications of uterine malformations and hysteroscopic treatment results. Hum Reprod Update. 2001 Mar-Apr;7(2):161-74. doi: 10.1093/humupd/7.2.161.

    PMID: 11284660RESULT

  • Kasius JC, Eijkemans RJ, Mol BW, Fauser BC, Fatemi HM, Broekmans FJ. Cost-effectiveness of hysteroscopy screening for infertile women. Reprod Biomed Online. 2013 Jun;26(6):619-26. doi: 10.1016/j.rbmo.2013.02.015. Epub 2013 Mar 14.

    PMID: 23602685RESULT

  • Keats JP. Patient safety in the obstetric and gynecologic office setting. Obstet Gynecol Clin North Am. 2013 Dec;40(4):611-23. doi: 10.1016/j.ogc.2013.08.004.

    PMID: 24286992RESULT

  • Kilic Y, Bastu E, Ergun B. Validity and efficacy of office hysteroscopy before in vitro fertilization treatment. Arch Gynecol Obstet. 2013 Mar;287(3):577-81. doi: 10.1007/s00404-012-2584-z. Epub 2012 Oct 6.

    PMID: 23053317RESULT

  • Polisseni F, Bambirra EA, Camargos AF. Detection of chronic endometritis by diagnostic hysteroscopy in asymptomatic infertile patients. Gynecol Obstet Invest. 2003;55(4):205-10. doi: 10.1159/000072075.

    PMID: 12904693RESULT

  • Nayak PK, Mahapatra PC, Mallick J, Swain S, Mitra S, Sahoo J. Role of diagnostic hystero-laparoscopy in the evaluation of infertility: A retrospective study of 300 patients. J Hum Reprod Sci. 2013 Jan;6(1):32-4. doi: 10.4103/0974-1208.112378.

    PMID: 23869148RESULT

  • Ray A, Shah A, Gudi A, Homburg R. Unexplained infertility: an update and review of practice. Reprod Biomed Online. 2012 Jun;24(6):591-602. doi: 10.1016/j.rbmo.2012.02.021. Epub 2012 Mar 7.

    PMID: 22503948RESULT

  • Romani F, Guido M, Morciano A, Martinez D, Gaglione R, Lanzone A, Selvaggi L. The use of different size-hysteroscope in office hysteroscopy: our experience. Arch Gynecol Obstet. 2013 Dec;288(6):1355-9. doi: 10.1007/s00404-013-2932-7. Epub 2013 Jun 25.

    PMID: 23797933RESULT

  • Ryan GL, Syrop CH, Van Voorhis BJ. Role, epidemiology, and natural history of benign uterine mass lesions. Clin Obstet Gynecol. 2005 Jun;48(2):312-24. doi: 10.1097/01.grf.0000159538.27221.8c. No abstract available.

    PMID: 15805789RESULT

  • Salim S, Won H, Nesbitt-Hawes E, Campbell N, Abbott J. Diagnosis and management of endometrial polyps: a critical review of the literature. J Minim Invasive Gynecol. 2011 Sep-Oct;18(5):569-81. doi: 10.1016/j.jmig.2011.05.018. Epub 2011 Jul 23.

    PMID: 21783430RESULT

  • Scholten I, Moolenaar LM, Gianotten J, van der Veen F, Hompes PG, Mol BW, Steures P. Long term outcome in subfertile couples with isolated cervical factor. Eur J Obstet Gynecol Reprod Biol. 2013 Oct;170(2):429-33. doi: 10.1016/j.ejogrb.2013.06.042. Epub 2013 Aug 3.

    PMID: 23921361RESULT

  • Shokeir T, Abdelshaheed M, El-Shafie M, Sherif L, Badawy A. Determinants of fertility and reproductive success after hysteroscopic septoplasty for women with unexplained primary infertility: a prospective analysis of 88 cases. Eur J Obstet Gynecol Reprod Biol. 2011 Mar;155(1):54-7. doi: 10.1016/j.ejogrb.2010.11.015. Epub 2010 Dec 23.

    PMID: 21185112RESULT

  • Umranikar S, Clark TJ, Saridogan E, Miligkos D, Arambage K, Torbe E, Campo R, Di Spiezio Sardo A, Tanos V, Grimbizis G; British Society for Gynaecological Endoscopy /European Society for Gynaecological Endoscopy Guideline Development Group for Management of Fluid Distension Media in Operative Hysteroscopy. BSGE/ESGE guideline on management of fluid distension media in operative hysteroscopy. Gynecol Surg. 2016;13(4):289-303. doi: 10.1007/s10397-016-0983-z. Epub 2016 Oct 6. No abstract available.

    PMID: 28003797RESULT

  • Wortman M, Daggett A, Ball C. Operative hysteroscopy in an office-based surgical setting: review of patient safety and satisfaction in 414 cases. J Minim Invasive Gynecol. 2013 Jan-Feb;20(1):56-63. doi: 10.1016/j.jmig.2012.08.778. Epub 2012 Oct 27.

    PMID: 23107759RESULT

Study Officials

  • Amr M Al helaly, PhD

    Ain Shams University (Obs&Gyn)

    STUDY DIRECTOR

  • Kaled S Mohamed, PhD

    Ain Shams University (Obs&Gyn)

    STUDY CHAIR

Central Study Contacts

Hanan H EL Khateeb, MS

CONTACT

00201008834646drsamehhabib@yahoo.com

Dina Y Mansour, PhD

CONTACT

00201006575414dinayahiamansour@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr

Study Record Dates

First Submitted

December 17, 2017

First Posted

December 21, 2017

Study Start

April 1, 2018

Primary Completion

December 1, 2019

Study Completion

February 1, 2020

Last Updated

April 3, 2018

Record last verified: 2018-04

Locations

EG(1)