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Completed

NCT Number: NCT04335864

Comparing the Impact of 2 Different Techniques in Management of Hydrosalpinx on Pregnancy Rates Following ICSI

Assessment and comparing pregnancy outcomes in hydrosalpinx patients treated by hysteroscopic tubal occlusion and laparoscopic salpingectomy before ICSI.

Completed

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kasr Alainy hospital-cairo University

Cairo, 11562, Egypt

About this study

Hydrosalpinx has a detrimental effect on the rates of implantation, pregnancy and early pregnancy loss following IVF. A meta-analysis demonstrated that the implantation rate and clinical pregnancy rate decreased by 50% in patients with hydrosalpinx. The negative consequences could be due to embryotoxic properties, a decrease in endometrial receptivity, and hydrosalpinx fluid mechanically flushing the embryo from the uterus.

Although laparoscopic salpingectomy and laparoscopic proximal ligation increase ongoing pregnancy rates in women with hydrosalpinges, those interventions are invasive and carry anaesthetic and surgical risks, especially in the presence of extensive adhesions, often seen in women with hydrosalpinges. In view of the possible adverse effects of laparoscopic surgery, an alternative less-invasive treatment for hydrosalpinges prior to IVF would be useful.

The effectiveness of hysteroscopic tubal occlusion when compared with salpingectomy has not been established. Randomized clinical trials comparing both procedures prior to IVF are lacking.

The present study was designed to compare hysteroscopic tubal occlusion and laparoscopic salpingectomy in the treatment of hydrosalpinges prior to IVF.

This study hypothesized that in women scheduled for IVF/ICSI hysteroscopic proximal occlusion of hydrosalpinges would be non-inferior to laparoscopic salpingectomy in terms of ongoing pregnancy rates following IVF/ICSI.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • primary or secondary infertility cases
  • unilateral or bilateral hydrosalpinx proved by HSG (hystersalpingogram) or by TVUS(transvaginal ultrasound) .

Exclusion criteria

  • Uterine factor of infertility
  • male factor of infertility
  • preexisting ovarian pathology
  • Presence of septic focus
  • medical or surgical conditions that contraindicated pregnancy

Treatment and study plan

Laparoscopic salpingectomy

Procedure

39 patients with hydrosalpinx will have laparoscopic salpingectomy

Hystroscopic proximal tubal occlusion

Procedure

39 patients with hydrosalpinx will have hysteroscopic proximal tubal occlusion

Primary outcomes

  1. Clinical pregnancy rate following ICSI

    Time frame: 14 days after Embryo transfer

    Defined as positive qualitative bhcg(beta human chorionic gonadotropin)

Secondary outcomes

  1. Ongoing pregnancy following ICSI

    Time frame: 8 weeks after Embryo transfer

    Defined as positive fetal heart rate on ultrasound at 8weeks gestation

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

A Clinical Trial Comparing Laparoscopic Salpingectomy Versus Hysteroscopic Proximal Tubal Occlusion on Pregnancy Rates Following ICSI (Intra-Cytoplasmic Sperm Injection) in Infertile Cases of Hydrosalpinx.

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 6, 2020
Registry last updated
Jun 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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