Routine Hysteroscopy in IVF/ICSI Cycles in Patients With Primary Unexplained Infertility

NCT02416596 | Unknown

• 1 other identifier: ASMH-RH1
• Study Type: interventional
• Target: 680
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the present study is to evaluate the impact of hysteroscopy prior to starting the IVF (in vitro fertilisation) cycle on treatment outcome in women with unexplained primary infertility.

Conditions

Primary Infertility Unspecified; Infertility; Ovarian Hyperstimulation; Pregnancy

Keywords

ICSI; IVF; hysteroscopy; Supervision; In-vitro Fertilization

Outcome Measures

Primary Outcomes (1)

• Biochemical Pregnancy

  Pregnancy determined by chemical test (2 weeks) and vag. U/S (ultrasound) (6 weeks)

  2-6 weeks

Study Arms (2)

Group Undergoing Hysterosopy

EXPERIMENTAL

This group will include 340 women with unexplained primary infertility undergoing their first trial of IVF/ICSI (intracytoplasmic sperm injection). This group will undergo hysteroscopy in the mid luteal phase of the proceeding cycle.

Procedure: Hysteroscopy; Device: Hysteroscope

Group With No intervention

NO INTERVENTION

This group will include 340 women with unexplained primary infertility they will undergo their first trial of IVF/ICSI (intracytoplasmic sperm injection) without hysteroscopy in the mid Luteal phase of the proceeding cycle.

Interventions

Hysteroscopy PROCEDURE

Office hysteroscopy will be performed during the Luteal phase of the proceeding 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.

Also known as: ROH: Routine Office Hysteroscopy

Group Undergoing Hysterosopy

Hysteroscope DEVICE

The device used is a rigid hysteroscope (continuous flow, 30 degree forward oblique view) assembled in a 4-mm diameter diagnostic 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

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients undergoing IVF/ICSI using the standard long GnRH-a (gonadotropin-releasing hormone-a) protocol.
• No evidence of uterine pathology by transvaginal ultrasound and hysterosalpingography during the follicular phase.
• Patients with unexplained primary infertility.

You may not qualify if:

• Patients undergoing IVF using other protocols of induction.
• Patients with evidence of uterine pathology by transvaginal ultrasound or hysterosalpingography during the follicular phase.
• Other causes of infertility rather than unexplained factor.
• Unexplained poor responders during the pending ICSI cycle.
• Patients with abnormal findings at hysteroscopy.

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Related Publications (11)

• El-Toukhy T, Sunkara SK, Coomarasamy A, Grace J, Khalaf Y. Outpatient hysteroscopy and subsequent IVF cycle outcome: a systematic review and meta-analysis. Reprod Biomed Online. 2008 May;16(5):712-9. doi: 10.1016/s1472-6483(10)60486-5.

  PMID: 18492377 BACKGROUND

• Pundir J, Pundir V, Omanwa K, Khalaf Y, El-Toukhy T. Hysteroscopy prior to the first IVF cycle: a systematic review and meta-analysis. Reprod Biomed Online. 2014 Feb;28(2):151-61. doi: 10.1016/j.rbmo.2013.09.025. Epub 2013 Oct 5.

  PMID: 24365027 BACKGROUND

• Loverro G, Nappi L, Vicino M, Carriero C, Vimercati A, Selvaggi L. Uterine cavity assessment in infertile women: comparison of transvaginal sonography and hysteroscopy. Eur J Obstet Gynecol Reprod Biol. 2001 Dec 10;100(1):67-71. doi: 10.1016/s0301-2115(01)00434-1.

  PMID: 11728660 BACKGROUND

• Karayalcin R, Ozyer S, Ozcan S, Uzunlar O, Gurlek B, Moraloglu O, Batioglu S. Office hysteroscopy improves pregnancy rates following IVF. Reprod Biomed Online. 2012 Sep;25(3):261-6. doi: 10.1016/j.rbmo.2012.05.013. Epub 2012 Jun 16.

  PMID: 22818094 BACKGROUND

• De Placido G, Clarizia R, Cadente C, Castaldo G, Romano C, Mollo A, Alviggi C, Conforti S. Compliance and diagnostic efficacy of mini-hysteroscopy versus traditional hysteroscopy in infertility investigation. Eur J Obstet Gynecol Reprod Biol. 2007 Nov;135(1):83-7. doi: 10.1016/j.ejogrb.2007.02.028. Epub 2007 May 3.

  PMID: 17481803 BACKGROUND

• Almog B, Shalom-Paz E, Dufort D, Tulandi T. Promoting implantation by local injury to the endometrium. Fertil Steril. 2010 Nov;94(6):2026-9. doi: 10.1016/j.fertnstert.2009.12.075. Epub 2010 Feb 19.

  PMID: 20171615 BACKGROUND

• Barash A, Dekel N, Fieldust S, Segal I, Schechtman E, Granot I. Local injury to the endometrium doubles the incidence of successful pregnancies in patients undergoing in vitro fertilization. Fertil Steril. 2003 Jun;79(6):1317-22. doi: 10.1016/s0015-0282(03)00345-5.

  PMID: 12798877 BACKGROUND

• Bosteels J, Weyers S, Puttemans P, Panayotidis C, Van Herendael B, Gomel V, Mol BW, Mathieu C, D'Hooghe T. The effectiveness of hysteroscopy in improving pregnancy rates in subfertile women without other gynaecological symptoms: a systematic review. Hum Reprod Update. 2010 Jan-Feb;16(1):1-11. doi: 10.1093/humupd/dmp033.

  PMID: 19744944 BACKGROUND

• Huang LN, Tan J, Hitkari J, Dahan MH. Should IVF be used as first-line treatment or as a last resort? A debate presented at the 2013 Canadian Fertility and Andrology Society meeting. Reprod Biomed Online. 2015 Feb;30(2):128-36. doi: 10.1016/j.rbmo.2014.10.004. Epub 2014 Oct 14.

  PMID: 25498596 BACKGROUND

• Hughes E, Brown J, Collins JJ, Vanderkerchove P. Clomiphene citrate for unexplained subfertility in women. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD000057. doi: 10.1002/14651858.CD000057.pub2.

  PMID: 20091498 BACKGROUND

• Lea RG, Sandra O. Immunoendocrine aspects of endometrial function and implantation. Reproduction. 2007 Sep;134(3):389-404. doi: 10.1530/REP-07-0167.

  PMID: 17709558 BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

Hysteroscopy; Hysteroscopes

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Endoscopes; Diagnostic Equipment; Equipment and Supplies; Surgical Equipment

Study Officials

• Khaled H Swaydan, PhD

  Ain Shams University (Obs&Gyn)

  STUDY DIRECTOR

• Ahmed K Mekled, PhD

  Ain Shams University (Obs&Gyn)

  STUDY CHAIR

Central Study Contacts

Amr A. Abdulreheem, MBBCh

CONTACT

+201006774459; amro984@gmail.com

Moustafa F Gomaa, PhD

CONTACT

01226188993

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 7, 2015
• First Posted: April 15, 2015
• Study Start: January 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 15, 2015

Record last verified: 2015-04