Hydrosalpinx Management Before Intracytoplasmic Sperm Injection

NCT03854292 | Completed

• 1 other identifier: tubal disconnection
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

ICSI pregnancy outcomes following hysteroscopic tubal electrocoagulation versus laparoscopic tubal disconnection for patients with hydrosalpinges

Conditions

Hydrosalpinx

Outcome Measures

Primary Outcomes (1)

• proximal tubal occlusion Success rate .

  proximal tubal occlusion Success rate among two groups detected by Hysterosalpingogram.

  15 months

Secondary Outcomes (1)

• Pregnancy rate among the two groups.

  15 months

Study Arms (2)

Hysteroscopic tubal electrocoagulation

Unilateral or bilateral electrocoagulation of the cornual end of the tube and the surrounding part of the uterine horn was performed using a hysteroscopic electrocoagulating roller ball

Procedure: Hysteroscopic tubal electrocoagulation

Laparoscopic tubal disconnection

Coagulation of the mid isthmus region of the affected Fallopian tube, with the bipolar forceps. using direct current that was no greater than 25 Watts.

Procedure: Hysteroscopic tubal electrocoagulation

Interventions

Hysteroscopic tubal electrocoagulation PROCEDURE

Unilateral or bilateral electrocoagulation of the cornual end of the tube and the surrounding part of the uterine horn was performed using a hysteroscopicelectrocoagulating roller ball.

Hysteroscopic tubal electrocoagulation; Laparoscopic tubal disconnection

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

50 patients who have unilateral or bilateral hydrosalpinges identified on hysterosalpingography and vaginal ultrasonography, and who are undergoing IVF.

You may qualify if:

• Age from 20 to 35 years
• Primary or secondary infertility.
• Diagnosis of hydrosalpinx; diagnosed by HSG and TV U/S.
• Necessity of an IVF procedure.

You may not qualify if:

• Patients with uterine factor infertility.
• Medical or surgical conditions contraindicating pregnancy.
• Poor responders according to reference criteria.
• Cases of polycystic ovary disease.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Related Publications (10)

• Strandell A, Waldenstrom U, Nilsson L, Hamberger L. Hydrosalpinx reduces in-vitro fertilization/embryo transfer pregnancy rates. Hum Reprod. 1994 May;9(5):861-3. doi: 10.1093/oxfordjournals.humrep.a138606.

  PMID: 7929732 BACKGROUND

• Strandell A, Lindhard A, Waldenstrom U, Thorburn J, Janson PO, Hamberger L. Hydrosalpinx and IVF outcome: a prospective, randomized multicentre trial in Scandinavia on salpingectomy prior to IVF. Hum Reprod. 1999 Nov;14(11):2762-9. doi: 10.1093/humrep/14.11.2762.

  PMID: 10548619 BACKGROUND

• Puttemans P, Campo R, Gordts S, Brosens I. Hydrosalpinx and ART: hydrosalpinx--functional surgery or salpingectomy? Hum Reprod. 2000 Jul;15(7):1427-30. doi: 10.1093/humrep/15.7.1427.

  PMID: 10875845 BACKGROUND

• Mijatovic V, Veersema S, Emanuel MH, Schats R, Hompes PG. Essure hysteroscopic tubal occlusion device for the treatment of hydrosalpinx prior to in vitro fertilization-embryo transfer in patients with a contraindication for laparoscopy. Fertil Steril. 2010 Mar 1;93(4):1338-42. doi: 10.1016/j.fertnstert.2008.11.022. Epub 2009 Jan 14.

  PMID: 19147140 BACKGROUND

• Savaris RF, Pedrini JL, Flores R, Fabris G, Zettler CG. Expression of alpha 1 and beta 3 integrins subunits in the endometrium of patients with tubal phimosis or hydrosalpinx. Fertil Steril. 2006 Jan;85(1):188-92. doi: 10.1016/j.fertnstert.2005.06.039.

  PMID: 16412752 BACKGROUND

• Hammadieh N, Afnan M, Evans J, Sharif K, Amso N, Olufowobi O. A postal survey of hydrosalpinx management prior to IVF in the United Kingdom. Hum Reprod. 2004 Apr;19(4):1009-12. doi: 10.1093/humrep/deh133. Epub 2004 Mar 11.

  PMID: 15016787 BACKGROUND

• Kontoravdis A, Makrakis E, Pantos K, Botsis D, Deligeoroglou E, Creatsas G. Proximal tubal occlusion and salpingectomy result in similar improvement in in vitro fertilization outcome in patients with hydrosalpinx. Fertil Steril. 2006 Dec;86(6):1642-9. doi: 10.1016/j.fertnstert.2006.05.032. Epub 2006 Oct 25.

  PMID: 17069813 BACKGROUND

• El-Mazny A, Abou-Salem N, Hammam M, Saber W. Hysteroscopic tubal electrocoagulation versus laparoscopic tubal ligation for patients with hydrosalpinges undergoing in vitro fertilization. Int J Gynaecol Obstet. 2015 Sep;130(3):250-2. doi: 10.1016/j.ijgo.2015.04.039. Epub 2015 Jul 2.

  PMID: 26140948 BACKGROUND

• Parihar M, Mirge A, Hasabe R. Hydrosalpinx functional surgery or salpingectomy? The importance of hydrosalpinx fluid in assisted reproductive technologies. J Gynecol Endosc Surg. 2009 Jan;1(1):12-6. doi: 10.4103/0974-1216.51903.

  PMID: 22442504 BACKGROUND

• Stadtmauer LA, Riehl RM, Toma SK, Talbert LM. Cauterization of hydrosalpinges before in vitro fertilization is an effective surgical treatment associated with improved pregnancy rates. Am J Obstet Gynecol. 2000 Aug;183(2):367-71. doi: 10.1067/mob.2000.107671.

  PMID: 10942471 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 23, 2019
• First Posted: February 26, 2019
• Study Start: March 1, 2017
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: July 15, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)