Estrogen in the Prevention of Adhesion Reformation

NCT03620929 | Unknown Phase 4

• 1 other identifier: 2018FXHEC-KY025
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

Asherman syndrome, which occurs after trauma to the basalis layer of the endometrium.It seems that the role of postoperative estrogen therapy in the prevention of recurrence of IU adhesions is still controversial. To investigate if estrogen therapy can prevent adhesion reformation after adhesiolysis. After the completion of hysteroscopic adhesiolysis, recruited patients will be randomized to one of the two treatment groups by computer-generated numbers: having estrogen after hysteroscopic adhesiolysis three months, all patients in this group will be treated with hormone therapy for 3 cycles; each cycle consists of estradiol 4mg per day for 21 days with addition of progestogen in the form of dydrogesterone 10mg per day for the last 7 days; and the control group without estrogen treatment. A second-look hysteroscopy and ultrasound assessment of the endometrium will be carried out 4 weeks after the surgery, and again at 8 weeks after the surgery.

Conditions

Asherman Syndrome

Keywords

estradiol

Outcome Measures

Primary Outcomes (1)

• AFS score

  The severity and extent of intrauterine adhesions will be scored according to a classification system recommended by the American Fertility Society (AFS) (1988 version).

  3 months

Study Arms (2)

Experiment group

EXPERIMENTAL

Having estrogen(Estradiol Valerate) after hysteroscopic adhesiolysis three months, all patients in this group will be treated with hormone therapy for 3 cycles; each cycle consists of estradiol 4mg per day for 21 days with addition of progestogen in the form of dydrogesterone 10mg per day for the last 7 days;

Drug: Estradiol Valerate

Control group

NO INTERVENTION

Control group without estrogen treatment. A second-look hysteroscopy and ultrasound assessment of the endometrium will be carried out 4 weeks after the surgery, and again at 8 weeks after the surgery.

Interventions

Estradiol Valerate DRUG

In all cases hormone therapy will be started from the day of operation, consisting of estradiol valerate at a dose of 4mg/d for 21 days, with the addition of dydrogesterone at a dose of 10 mg/d for the last 7 days of the estrogen therapy. After the withdrawal bleed, the hormone therapy will be repeated for another cycle. Second-look hysteroscopy will be carried out in the early proliferative phase, 4 weeks after the initial operation; a third-look hysteroscopy will be carried out 8 weeks after the initial operation. After assessment of the extent and severity of any reformed adhesion, hysteroscopic adhesiolysis will be carried out at the time of the second-look or third-look procedure, if adhesion had recurred.

Also known as: dydrogesterone

Experiment group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients with suspected Asherman syndrome

You may not qualify if:

• has received estrogen therapy within 3 month of enrolment. 2 suffers from leiomyoma, endometrial polyps, cancer, or polycystic ovarian syndrome (PCOS). 3.History of genital tuberculosis; and 4. contraindications for estrogen therapy.

Sponsors & Collaborators

• Fu Xing Hospital, Capital Medical University: lead

Study Sites (1)

Fuxing hospital

Beijing, Beijing Municipality, 100073, China

Location

Related Publications (7)

• March CM. Intrauterine adhesions. Obstet Gynecol Clin North Am. 1995 Sep;22(3):491-505.

  PMID: 8524533 BACKGROUND

• ASHERMAN JG. Traumatic intra-uterine adhesions. J Obstet Gynaecol Br Emp. 1950 Dec;57(6):892-6. doi: 10.1111/j.1471-0528.1950.tb06053.x. No abstract available.

  PMID: 14804168 BACKGROUND

• Schenker JG. Etiology of and therapeutic approach to synechia uteri. Eur J Obstet Gynecol Reprod Biol. 1996 Mar;65(1):109-13. doi: 10.1016/0028-2243(95)02315-j.

  PMID: 8706941 BACKGROUND

• Schenker JG, Margalioth EJ. Intrauterine adhesions: an updated appraisal. Fertil Steril. 1982 May;37(5):593-610. doi: 10.1016/s0015-0282(16)46268-0. No abstract available.

  PMID: 6281085 BACKGROUND

• Yu D, Wong YM, Cheong Y, Xia E, Li TC. Asherman syndrome--one century later. Fertil Steril. 2008 Apr;89(4):759-79. doi: 10.1016/j.fertnstert.2008.02.096.

  PMID: 18406834 BACKGROUND

• Roy KK, Negi N, Subbaiah M, Kumar S, Sharma JB, Singh N. Effectiveness of estrogen in the prevention of intrauterine adhesions after hysteroscopic septal resection: a prospective, randomized study. J Obstet Gynaecol Res. 2014 Apr;40(4):1085-8. doi: 10.1111/jog.12297. Epub 2014 Feb 26.

  PMID: 24612233 BACKGROUND

• Zhou Q, Wu X, Dai X, Yuan R, Qi H. The different dosages of estrogen affect endometrial fibrosis and receptivity, but not SDF-1/CXCR4 axis in the treatment of intrauterine adhesions. Gynecol Endocrinol. 2018 Jan;34(1):49-55. doi: 10.1080/09513590.2017.1328050. Epub 2017 May 20.

  PMID: 28531361 BACKGROUND

MeSH Terms

Conditions

Gynatresia

Interventions

Estradiol; Dydrogesterone

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pregnadienes; Pregnanes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: August 5, 2018
• First Posted: August 8, 2018
• Study Start: August 13, 2018
• Primary Completion: August 13, 2018
• Study Completion: December 1, 2022
• Last Updated: September 8, 2021

Record last verified: 2021-09

Locations

CN (1)