Early Progesterone Cessation After in Vitro Fertilization
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|ClinicalTrials.gov Identifier: NCT01177904|
Recruitment Status : Completed
First Posted : August 9, 2010
Last Update Posted : March 17, 2011
|Condition or disease||Intervention/treatment||Phase|
|All Patients Which Show a Gestational Sac in Their Uterus in the First US Are Included in This Study and Randomized.||Other: Cease progsterone at 5 Other: control group: progesterone 8||Phase 4|
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.
- Patients who underwent ovarian stimulation using GnRH analogues,
- Fresh embryo transfer,
- LPS by vaginal micronized P4,
- Clinical pregnancy demonstrated by US and
- Informed consent signed.
Patients who had bleeding episodes before their first US because they are likely to continue P4 therapy without medical indication.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Early Progesterone Cessation After in Vitro Fertilization|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
Active Comparator: Progesterone 5 Weeks
The study group stop receiving P4 on the day of their first US at 5 weeks pregnancy
Other: Cease progsterone at 5
Cease administration of progsterone at first US at 5 weeks
Control Group : P4 8 weeks
Progesterone will be given until 8 weeks of pregnancy
Other: control group: progesterone 8
Control group: progesterone until 8 weeks of pregnancy
- progesterone [ Time Frame: june 2009 ]
Our predictions are similar to those seen in previous studies:
No significant change in the miscarriage rate.
There may be a higher percentage of bleeding episodes in patients who stop LPS earlier, but it does not seem to have an impact.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01177904
|Madrid, Spain, 28023|
|Study Director:||Juan A Garcia-Velasco, MD, PhD||IVI Madrid|