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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02617108
Other study ID # FuXingH2
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 2019
Est. completion date November 2021

Study information

Verified date September 2019
Source Fu Xing Hospital, Capital Medical University
Contact Yu Xiao, Ph.D.
Phone +86-18601262217
Email 729995176@qq.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Patients who want to go TCRS will randomly divided 3 groups. In Group 1(100 patients), women received postoperative estrogen therapy. In Group 2 (100 patients), a Foley catheter with the balloon inflated with 4 ml of normal saline solution will be placed into the uterine cavity at the end of the operation for five days. In Group 3 (110 patients), women will not receive any of the treatment (comparison group). All subjects underwent two further hysteroscopy, one and three months after the initial surgery. At the second or third look hysteroscopy, the incidence of intra-uterine adhesion will be analyzed.


Description:

The uterine septum (US) is the most common congenital uterine malformation, accounting for about 75% of Mullerian anomalies. Transcervical resection of septum (TCRS) has been shown in several cohort studies to improve outcome, although evidence from prospectively conducted randomized trial is lacking. TCRS is generally considered to be safe but there is a concern that it may be complicated by post-operative formation of intrauterine adhesions. Some investigators therefore recommend the use of postoperative adjuvant therapies with a view to preventing adhesion formation, as in the case of hysteroscopic surgery for Asherman syndrome. The adjuvant measures proposed include postoperative estrogen therapy, the placement of an intrauterine device (IUD) or Foley catheter in the uterine cavity. Unlike the case of Asherman syndrome in which these various adjuvant therapies are often used and appear to be of benefit, it is uncertain if any of these adjuvant measures are of benefit or necessary in the case TCRS. In this study, the investigators will compare the postoperative adhesion formation rates who will receive Foley catheter therapies 、postoperative estrogen therapy and those who will not receive any therapies to determine the usefulness of Foley catheter therapies in reducing postoperative adhesion formation.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 310
Est. completion date November 2021
Est. primary completion date November 2021
Accepts healthy volunteers No
Gender Female
Age group 25 Years to 40 Years
Eligibility Inclusion Criteria:

- Patients who will go hysteroscopic transection of uterine septum between 2016 to 2017 at the Hysteroscopy Center, Fuxing Hospital;

- Patients willing to undergo followed hysteroscopy about 4 and 12 weeks after the surgery to assess the reformation of intrauterine adhesions;

- Written informed consent obtained.

Exclusion Criteria:

- ongoing pregnancy;

- Peroperative fever or infections;

- Malignancy;

- Precious pelvic inflammatory disease;

- Uterine fibroid (>3cm size);

- endometriosis;

- Contraindications for anesthesia;

- Not able to read and/or understand informed consent.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Foley balloon
a Foley balloon with 4 ml of normal saline solution will be placed into the uterine cavity at the end of the operation for five days.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Fu Xing Hospital, Capital Medical University

References & Publications (4)

Brucker SY, Rall K, Campo R, Oppelt P, Isaacson K. Treatment of congenital malformations. Semin Reprod Med. 2011 Mar;29(2):101-12. doi: 10.1055/s-0031-1272472. Epub 2011 Mar 24. Review. — View Citation

Conforti A, Alviggi C, Mollo A, De Placido G, Magos A. The management of Asherman syndrome: a review of literature. Reprod Biol Endocrinol. 2013 Dec 27;11:118. doi: 10.1186/1477-7827-11-118. Review. — View Citation

Hassan MA, Lavery SA, Trew GH. Congenital uterine anomalies and their impact on fertility. Womens Health (Lond). 2010 May;6(3):443-61. doi: 10.2217/whe.10.19. Review. — View Citation

Lin X, Wei M, Li TC, Huang Q, Huang D, Zhou F, Zhang S. A comparison of intrauterine balloon, intrauterine contraceptive device and hyaluronic acid gel in the prevention of adhesion reformation following hysteroscopic surgery for Asherman syndrome: a cohort study. Eur J Obstet Gynecol Reprod Biol. 2013 Oct;170(2):512-6. doi: 10.1016/j.ejogrb.2013.07.018. Epub 2013 Aug 7. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary A comparison of the presence and severity(American Fertility Society score) of intra-uterine adhesions at second look and third look hysteroscopy the incidence and severity of adhesions (as measured according to the American Fertility Society scoring system) between the groups 1 year
See also
  Status Clinical Trial Phase
Recruiting NCT06315582 - Surgical Approach to Uterine Septum N/A
Completed NCT05139446 - Reproductive Outcomes Following Uterine Septum Resection
Completed NCT02853695 - Implementation of Hysteroscopy in Flanders and the Netherlands
Active, not recruiting NCT03880435 - HYALOBARRIER® GEL ENDO Versus no HYALOBARRIER® GEL ENDO Following Operative Hysteroscopy for Improving Reproductive Outcome in Women With Intrauterine Pathology Wishing to Become Pregnant N/A