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This is a multicenter randomized controlled trial comparing the efficacy and safety of two endometrial preparation protocols for the first frozen embryo transfer cycle in PCOS with whole embryo freezing. Subjects will be randomized to letrozole-stimulated group or hormone replacement treatment group in their first frozen embryo transfer cycle, and their pregnancy and perinatal outcomes during this cycle will be followed up and analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Letrozole-stimulated group | Experimental |
| |
| Hormone replacement treatment group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Letrozole | Procedure | Oral Letrozole at a dose of 2.5mg daily will be started on days 3-5 of the menstrual cycle and will be continued for 5 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Live birth rate | Number of women with live birth/ number of women randomized to the specific group. Live birth is defined as the delivery of any viable infant at 28 weeks or more of gestation. | 11 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical pregnancy rate | Number of women with clinical pregnancy /number of women randomized to the specific group. Clinical pregnancy was defined as the presence of at least one gestational sac in the uterine cavity on ultrasound at about 28 days after embryo transfer. | 2 months |
| Biochemical pregnancy rate |
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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 | Recruiting | Changsha | Hunan | 410000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37591656 | Derived | Wang X, Li Y, Zhang C, Feng YR, Deng B, Zhang S, Ma Y, Wu Y, Lin G, Gong F. Live birth after letrozole-stimulated cycles versus hormone replacement treatment cycles for the first frozen embryo transfer in women with polycystic ovary syndrome: protocol for a multicentre randomised controlled trial. BMJ Open. 2023 Aug 17;13(8):e072021. doi: 10.1136/bmjopen-2023-072021. |
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All the individual participant data collected during the trial will be shared after deidentification upon request.
Study protocol, Statistical analysis plan, informed consent forms, and clinical study report will be available upon request.
Data will be available from 3 months following first publication and ending 5 years after the study has been concluded.
Individual participant data will be shared with researches who provide a methodologically sound proposal and whose proposed use of the data has been approved by an independent review committee.
Data will be available from 3 months following first publication and ending 5 years after the study has been concluded.
Individual participant data will be shared with researches who provide a methodologically sound proposal and whose proposed use of the data has been approved by an independent review committee.
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| Oral estradiol valerate | Procedure | Oral estradiol valerate at a dose of 3mg twice daily will be started on days 3-5 of the menstrual cycle. |
|
Number of women with biochemical pregnancy /number of women randomized to the specific group. Biochemical pregnancy was defined as a human chorionic gonadotropin level of more than 10 milli-International unit (mIU) per milliliter (ml) as measured at about 14 days after embryo transfer. |
| 1.5 months |
| Miscarriage rate | Number of women with miscarrage / number of women with clinical pregnancy. Miscarriage refers to a complete spontaneous abortion or a nonviable pregnancy before 28 weeks of gestation. | 9 months |
| Cycle cancellation rate | Number of women who initiated endometrial preparation without embryos transfer / number of women randomized to the specific group. | 1 month |
| Birth weight | Weight of newborns at delivery. | 11 months |
| Incidence of obstetric and perinatal complications | Number of pregnancies with complications / number of clinical pregnancies. | 11 months |
| Incidence of neonatal complications | Number of live births with neonatal complications / number of live births. | 11 months |
| Ectopic pregnancy rate | Number of women with ectopic pregnancy /number of women randomized to the specific group. Ectopic pregnancy will be defined as implantation outside the uterine cavity, as confirmed by sonography or laparoscopy. | 2 months |
| ID | Term |
|---|---|
| D000077289 | Letrozole |
| D004958 | Estradiol |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | 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 |
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