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There seems to be a general consensus on the supplementation of progesterone (P4) for luteal phase support (LPS) to all women after in vitro fertilization (IVF) treatment. However, there is no agreement about the precise duration of LPS.
The objective of the study is to investigate the effect of early cessation of progesterone for LPS after IVF treatment on the pregnancy outcome, with special interest in determining the miscarriage rate and episodes of bleeding between the date of the first ultrasound (US) and up to 12 weeks of gestation.
Patients start to receive 200 mg twice a day of P4 on the day after oocyte retrieval.
All patients which show a gestational sac in their uterus in the first US are included in this study and randomized.
Inclusion criteria:
Exclusion criteria:
Patients who had bleeding episodes before their first US because they are likely to continue P4 therapy without medical indication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Progesterone 5 Weeks | Active Comparator | The study group stop receiving P4 on the day of their first US at 5 weeks pregnancy |
|
| Control Group : P4 8 weeks | Other | Progesterone will be given until 8 weeks of pregnancy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cease progsterone at 5 | Other | Cease administration of progsterone at first US at 5 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Bleeding Episodes | Number of bleeding episodes up to a year | Up to year |
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Inclusion Criteria:
Exclusion Criteria:
Patients who had bleeding episodes before their first US because they are likely to continue P4 therapy without medical indication.
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| Name | Affiliation | Role |
|---|---|---|
| Juan A Garcia-Velasco, MD, PhD | IVI Madrid | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IVI-Madrid | Madrid | 28023 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22749223 | Derived | Kohls G, Ruiz F, Martinez M, Hauzman E, de la Fuente G, Pellicer A, Garcia-Velasco JA. Early progesterone cessation after in vitro fertilization/intracytoplasmic sperm injection: a randomized, controlled trial. Fertil Steril. 2012 Oct;98(4):858-62. doi: 10.1016/j.fertnstert.2012.05.046. Epub 2012 Jun 29. |
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Progesterone during 1st trimester
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| ID | Title | Description |
|---|---|---|
| FG000 | Progesterone 5 Weeks | The study group stop receiving progesterone on the day of their first Ultra-sound at 5 weeks pregnancy Cease progesterone at 5: Cease administration of progesterone at first Ultra-sound at 5 weeks |
| FG001 | Control Group : Progesterone 8 Weeks | Progesterone will be given until 8 weeks of pregnancy control group: progesterone 8: Control group: progesterone until 8 weeks of pregnancy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Women
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| ID | Title | Description |
|---|---|---|
| BG000 | Progesterone 5 Weeks | The study group of women stop receiving P4 on the day of their first US at 5 weeks pregnancy Cease progsterone at 5: Cease administration of progsterone at first US at 5 weeks |
| BG001 | Control Group : P4 8 Weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Bleeding Episodes | Number of bleeding episodes up to a year | Posted | Mean | Standard Deviation | Episodes of bleeding | Up to year |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group : P4 8 Weeks | Progesterone will be given until 8 weeks of pregnancy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Graciela Kohls | IVI Madrid | 91 180 29 00 | graciela.kohls@ivi.es |
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| control group: progesterone 8 | Other | Control group: progesterone until 8 weeks of pregnancy |
|
Progesterone will be given until 8 weeks of pregnancy control group: progesterone 8: Control group: progesterone until 8 weeks of pregnancy |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Bleeding Episodes | Bleeding Episodes in each group. | Mean | Standard Deviation | Bleeding episodes |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 100 |
| 0 |
| 100 |
| 0 |
| 100 |
| EG001 | Study Group: P4 5 Weeks | Progesterone will be given until 5 weeks of pregnancy | 0 | 100 | 0 | 100 | 0 | 100 |
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