Estrogen in the Prevention of Adhesion Reformation
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|ClinicalTrials.gov Identifier: NCT03620929|
Recruitment Status : Enrolling by invitation
First Posted : August 8, 2018
Last Update Posted : January 5, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Asherman Syndrome||Drug: Estradiol Valerate||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||186 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The Effect of Estrogen in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis|
|Actual Study Start Date :||August 13, 2018|
|Estimated Primary Completion Date :||August 1, 2021|
|Estimated Study Completion Date :||December 1, 2021|
Experimental: Experiment group
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
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.
Other Name: dydrogesterone
No Intervention: Control group
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.
- AFS score [ Time Frame: 3 months ]The severity and extent of intrauterine adhesions will be scored according to a classification system recommended by the American Fertility Society (AFS) (1988 version).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03620929
|Beijing, Beijing, China, 100073|