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Evaluation of endometrial preparation using either human menopausal gonadotrophin (HMG) stimulation and hormone replacement therapy (HRT) prior to blastocyst transfer in patients with moderate to severe intrauterine adhesion (IUA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental-HMG stimulation group | Experimental | Women will be subjected to ovarian stimulation for endometrial preparation using human menopausal gonadotrophin before blastocyst transfer |
|
| Control-HRT group | Active Comparator | Women will be subjected to hormone replacement therapy for endometrial preparation before blastocyst transfer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| human menopausal gonadotrophin | Drug | experimental group:Women will be given HMG 37.5-150IU daily followed by monitoring of the follicular growth (folliculometry) when serum Estradiol (E2)<100pg/ml，progesterone (P)<1ng/ml. Final oocyte maturation will be induced by administration of human chorionic gonadotropin (HCG) when there will be at least one leading follicle ≥20mm in diameter followed by luteal phase support (using progesterone supplements) after 24 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Ongoing pregnancy rate | Ongoing pregnancy is defined as the presence of a gestational sac with foetal heartbeat by transvaginal ultrasound at 10th week after embryo transfer（ET） | 10th week after embryo transfer |
| Measure | Description | Time Frame |
|---|---|---|
| Cycle cancellation rate | the day of embryo transfer | |
| Implantation rate | Sacs seen in early ultrasound divided by the number of embryos transferred | 4th weeks after embryo transfer |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reproductive & Genetic Hospital of CITIC-XIANGYA | Changsha | Hunan | 410000 | China |
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| hormone replacement therapy | Drug | Women will be given 17 β-estradiol hemihydrate 2 mg and estrogen gel 5 g daily from day 3 of the cycle then the endometrial thickness will be assessed on day 7 by transvaginal sonography (TVS). If the endometrium is ≥ 9 mm, luteal phase support (using progesterone supplements) will be started but if the endometrium is < 9 mm, estradiol will be continued until reaching appropriate endometrial thickness and then the luteal phase support will be started. The cycle will be cancelled If the estradiol administration >60 days. |
|
| Clinical pregnancy rate | Number of patients with ultrasound evidence of pregnancy divided by the number of embryo transfers | 4th weeks after embryo transfer |
| Early miscarriage rate | Number of losses of clinical pregnancies divided by number of clinical pregnancies | 12th weeks gestational age |
| Biochemical pregnancy rate | number of pregnancies with a transient elevation of serum human chorionic gonadotropin(β-hCG) level (>10 mIU/ml) divided by number of embryo transfers | 4th weeks after embryo transfer |
| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| D006175 | Gynatresia |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D007246 | Infertility |
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| ID | Term |
|---|---|
| D008596 | Menotropins |
| D020249 | Hormone Replacement Therapy |
| ID | Term |
|---|---|
| D006065 | Gonadotropins, Pituitary |
| D006062 | Gonadotropins |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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