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This study aims to compare the efficacy, in terms of progesterone levels and clinical outcomes, of two different presentations of micronized vaginal progesterone (400 mg vs. 200 mg) used in endometrial preparation in artificial cycle (AC) for embryo transfer.
This is a non-inferiority, retrospective case-control study, with at least 200 cycles analyzed (at least 100 per arm) and the primary outcome is the serum progesterone level on the day of the embryo transfer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 400 mg | Treatments where 400 mg tablet presentation of micronized vaginal progesterone was used, the protocol being one vaginal tablet twice a day. |
| |
| 200 mg | Treatments where 200 mg tablet presentation of micronized vaginal progesterone was used, the protocol being two vaginal tablets twice a day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaginally administered progesterone | Drug | The artificial endometrial preparation for an embryo transfer with the use of 400 mg vaginal tablet (one tablet twice a day) or 200 mg (two tablets twice a day) |
| Measure | Description | Time Frame |
|---|---|---|
| Serum progesterone level | On the day of embryo transfer |
| Measure | Description | Time Frame |
|---|---|---|
| Need for additional progesterone supplementation | assessed on the day of the embryo transfer | |
| Clinical results (ongoing pregnancy and miscarriage rate) | assessed on the day of the pregnancy test and during the pregnancy evolution |
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Inclusion Criteria:
Exclusion Criteria:
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The population will be selected among those patients who have undergone embryo transfer treatment with endometrial preparation in a artificial cycle at the Instituto Bernabeu.
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| Name | Affiliation | Role |
|---|---|---|
| Joaquín Llácer, MD PhD | Instituto Bernabeu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Bernabeu | Alicante | Valencia | 03016 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29040638 | Result | Labarta E, Mariani G, Holtmann N, Celada P, Remohi J, Bosch E. Low serum progesterone on the day of embryo transfer is associated with a diminished ongoing pregnancy rate in oocyte donation cycles after artificial endometrial preparation: a prospective study. Hum Reprod. 2017 Dec 1;32(12):2437-2442. doi: 10.1093/humrep/dex316. | |
| 33340402 |
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The information collected in the study will always be treated as grouped data and never as individual or personal data, thus maintaining anonymity and confidentiality.
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| Labarta E, Mariani G, Paolelli S, Rodriguez-Varela C, Vidal C, Giles J, Bellver J, Cruz F, Marzal A, Celada P, Olmo I, Alama P, Remohi J, Bosch E. Impact of low serum progesterone levels on the day of embryo transfer on pregnancy outcome: a prospective cohort study in artificial cycles with vaginal progesterone. Hum Reprod. 2021 Feb 18;36(3):683-692. doi: 10.1093/humrep/deaa322. |