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Practical issues
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| Name | Class |
|---|---|
| University Hospital, Ghent | OTHER |
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To offer patients with oligomenorrhoea or amenorrhoea an alternative to frozen embryo transfer in an artificial cycle, endometrial preparation using letrozole may be a valuable option. Letrozole, a potent, reversible nonsteroidal aromatase inhibitor with relatively short half-life, can successfully induce ovulation without any adverse anti-estrogenic effects and thus without affecting the endometrium. The use of letrozole typically results in monofollicular growth and this reduces the effect of supraphysiological levels of estrogen on the endometrium and embryo. The purpose of this study is to compare a frozen-thawed embryo transfer in an artificial cycle with a letrozole-induced ovulatory cycle, specifically in PCOS patients. The primary outcome is early pregnancy loss.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hormonal Replacement Therapy | Active Comparator | Artificial preparation of the endometrium using estradiol valerate 2mg 3x/day, and vaginal micronized progesterone 2x 400mg/day. |
|
| Letrozole | Experimental | Using letrozole for ovulation induction before planning the frozen embryo transfer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Letrozole | Drug | Letrozole ovulation induction |
| |
| estradiol valerate |
| Measure | Description | Time Frame |
|---|---|---|
| early pregnancy loss | 12 weeks after frozen embryo transfer |
| Measure | Description | Time Frame |
|---|---|---|
| cancellation rate | 2 months | |
| number of visits to the clinic | 2 months | |
| endometrial thickness on the day of planning of FET |
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Inclusion Criteria:
Exclusion Criteria:
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Sharing with other study site, UZ Gent
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077289 | Letrozole |
| D004958 | Estradiol |
| D011374 | Progesterone |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 |
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| Drug |
hormonal replacement therapy |
|
|
| 1 day |
| implantation rate | 1 day |
| biochemical and clinical pregnancy rate | 12 weeks |
| live birth rate | 1 year |
| neonatal birth weight | 1 year |
| term of delivery | 1 year |
| hypertensive disorders of pregnancy | 1 year |
| D000091662 | Genital Diseases |
| D007246 | Infertility |
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D003339 | Corpus Luteum Hormones |
| D045167 | Progesterone Congeners |