CClinicalTrials.gg
CompletedNCT05195073Updated Aug 16, 2023

Three Dimensional Versus Two Dimensional Laparoscopic Salpingectomy in Patients With Hydrosalpinx Undergoing IVF-ET

An interventional study of Laparoscopy in Hydrosalpinx, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2023-08-16.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
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Study summary

A three-dimensional laparoscopic vision system (3-D LVS) has gained acceptance and is being utilized in daily practice despite debates about its success.

Read the detailed description

A three-dimensional laparoscopic vision system (3-D LVS) has gained acceptance and is being utilized in daily practice despite debates about its success. in our study we will compare operative data and early postoperative outcomes of laparoscopic salpingectomy operations conducted using standard 2-D and 3-D laparoscopic vision systems

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Conditions studied

  • Hydrosalpinx

Keywords

  • Hydrosalpinx
  • Infertility
  • In vitro fertilization
  • Laparoscopy
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In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with unilateral hydrosalpinx diagnosed with hysterosalpingography or laparoscopy

Exclusion criteria

Exclusion Criteria:

  • Bilateral hydrosalpinx,
  • co-existent adnexal pathology,
  • body mass index (BMI) more than 40,
  • extensive pelvic adhesions,
  • coagulation defects or concurrent anticoagulant therapy,
  • compromised cardiopulmonary status,
  • and contraindications for general anesthesia.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
36 participants (actual)

Study arms

  • Active comparator
    3 D laparoscopy group

    salpingectomy will be performed by using Storz image 1 S 3D laparoscopy system (Karl Storz, Tuttlingen, Germany) which is comprised of a 10 mm scope with 2 full HD sensors at the tip of the scope and a 3 D control unit plus a 3 D display

    Biological: Laparoscopy

  • Active comparator
    2 D laparoscopy group

    salpingectomy will be performed by using a conventional 2 D laparoscopy system.

    Biological: Laparoscopy

Interventions

  • BiologicalLaparoscopy

    3 D laparoscopy

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What researchers measure

Primary outcomes

  1. The time required to excise the hydrosalpinx

    The time required to excise the hydrosalpinx

    Time frame: 6 months

Secondary outcomes

  1. The degree of difficulty experienced by the surgeon

    The degree of difficulty experienced by the surgeon during excision of the hydrosalpinx \[ evaluated using a visual analog scale ranging from 0 (least difficult) to 10 (most difficult)\].

    Time frame: 6 months

  2. The total operative time.

    The total operative time.

    Time frame: 6 months

  3. The amount of Intraoperative blood loss.

    The amount of Intraoperative blood loss.

    Time frame: 6 months

  4. Rate of intraoperative and postoperative complications.

    Rate of intraoperative and postoperative complications.

    Time frame: 6 months

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Study locations

1 site
  • Cairo University
    Cairo, 12613, Egypt
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References and documents

Publications

  • Fouda UM, Sayed AM. Effect of ultrasound-guided aspiration of hydrosalpingeal fluid during oocyte retrieval on the outcomes of in vitro fertilisation-embryo transfer: a randomised controlled trial (NCT01040351). Gynecol Endocrinol. 2011 Aug;27(8):562-7. doi: 10.3109/09513590.2010.507290. Epub 2010 Jul 30. PubMed 20672903 ↗
  • 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. PubMed 10548619 ↗
  • Fouda UM, Sayed AM, Abdelmoty HI, Elsetohy KA. Ultrasound guided aspiration of hydrosalpinx fluid versus salpingectomy in the management of patients with ultrasound visible hydrosalpinx undergoing IVF-ET: a randomized controlled trial. BMC Womens Health. 2015;15:21. doi: 10.1186/s12905-015-0177-2. Epub 2015 Feb 27. PubMed 25783650 ↗
  • Johnson N, van Voorst S, Sowter MC, Strandell A, Mol BW. Surgical treatment for tubal disease in women due to undergo in vitro fertilisation. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD002125. doi: 10.1002/14651858.CD002125.pub3. PubMed 20091531 ↗
  • Fouda UM, Elsetohy KA, Elshaer HS. Barbed Versus Conventional Suture: A Randomized Trial for Suturing the Endometrioma Bed After Laparoscopic Excision of Ovarian Endometrioma. J Minim Invasive Gynecol. 2016 Sep-Oct;23(6):962-8. doi: 10.1016/j.jmig.2016.06.008. Epub 2016 Jun 18. PubMed 27329547 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 16, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05195073
Lead sponsor
Cairo University
Responsible party
Marwa Mohamed Abdalla (lecturer of Obstetrics and Gynecology, Cairo University) — Principal investigator
First posted
Jan 18, 2022
Start date
Apr 1, 2022
Primary completion
Dec 30, 2022
Completion
Dec 30, 2022
Last update
Aug 16, 2023

Study contacts

Marwa M Abdalla
principal investigator · Kasralainy teaching hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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