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| ID | Type | Description | Link |
|---|---|---|---|
| BJ2023YCPYJH003 | Other Grant/Funding Number | China Health & Medical Development Foundation |
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Induced abortion is a common method to terminate pregnancy, but during the operation, it is necessary to dilate the cervix and aspirate the uterine cavity. Repeated induced abortions may increase the risk of uterine damage, leading to cervical stenosis or intrauterine adhesions, thinning of the endometrium, which may affect the implantation of fertilized eggs and the development of embryos, and ultimately may lead to infertility or miscarriage. This study aims to explore the effects of combined estrogen and progesterone on endometrial repair and ovarian function recovery after induced abortion.
Postoperative care after induced abortion should prioritize the issue of endometrial repair. In 2021, the Family Planning Branch of the Chinese Medical Association published the "Expert Consensus on Promoting Endometrial Repair After Induced Abortion" [10], emphasizing the importance of endometrial repair for high-risk populations following induced abortion. Currently, clinically, methods to promote endometrial repair include estrogen-progestin medications, compound short-acting oral contraceptives, traditional Chinese medicine, and bioelectric stimulation. However, controversies still exist regarding endometrial repair, and selecting an effective and safe treatment plan remains crucial. This study aims to prospectively evaluate the efficacy and safety of estradiol/estradiol/dydrogesterone in endometrial repair after induced abortion through clinical research, providing a basis for endometrial repair and ovarian function recovery post-abortion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Femoston group | Experimental | Starting from the day of the induced abortion surgery, take 17β-estradiol/dydrogesterone tablets orally for 28 days (take 2mg of 17β-estradiol orally once a day for the first 14 days, and then take 2mg of 17β-estradiol + 10mg of dydrogesterone tablets orally once a day for the next 14 days).The medication product name is called Femoston。 |
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| No Femoston group | No Intervention | The blank control group did not receive Femoston（17β-estradiol/dydrogesterone tablets after induced abortion surgery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 17β-estradiol/dydrogesterone tablets | Drug | The medication group began taking 17β-estradiol/dydrogesterone tablets orally for 28 days starting from the first day after induced abortion surgery (taking 2mg of 17β-estradiol orally once a day for the first 14 days, and then taking 2mg of 17β-estradiol + 10mg of dydrogesterone tablets orally once a day for the next 14 days). The blank control group did not take any medication. |
| Measure | Description | Time Frame |
|---|---|---|
| The thickness of the endometrium | Measurement of endometrial thickness by B-ultrasound on the 21st day after induced abortion surgery | The 21st day after induced abortion surgery |
| Cycle normalization rate | proportion of ovarian function recovery; blood sampling for estradiol and progesterone level check on the 21st day of the first post-operative menstrual cycle | 21st day of the first post-operative menstrual cycle |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of vaginal bleeding after surgery | number of days of vaginal bleeding after induced abortion surgery | The 21st day after induced abortion surgery |
| menstrual flow volume | Amount of menstrual flow during the first menstrual cycle after surgery |
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Inclusion Criteria:
Exclusion Criteria:
Pregnancy can happened to female only.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiuxiu Jiang, Ph.D | Contact | +8613588709941 | jiangxiuxiu0418@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiuxiu Jiang, Ph.D | Women's Hospital School Of Medicine Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's Hospital School Of Medicine Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310006 | China |
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| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D006175 | Gynatresia |
| ID | Term |
|---|---|
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004394 | Dydrogesterone |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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The eligible population who underwent induced abortion were divided into two groups using block randomization. The experimental group received estrogen and progesterone therapy after surgery, while the other group served as a blank control group. Twenty-one days after surgery, a follow-up examination was conducted to assess the recovery of the endometrium and measure the endometrial thickness. Twenty-one days after the first post-operative menstrual cycle, blood samples were taken for laboratory tests to evaluate the recovery of ovarian function.
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| 21st day of the first post-operative menstrual cycle |
| D000091662 | Genital Diseases |
| D011083 |
| Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |