Early Progesterone Cessation After in Vitro Fertilization

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 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. Exclusion criteria: Patients who had bleeding episodes before their first US because they are likely to continue P4 therapy without medical indication.

Official Title
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Early Progesterone Cessation After in Vitro Fertilization

Conditions
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All Patients Which Show a Gestational Sac in Their Uterus in the First US Are Included in This Study and Randomized.

Intervention / Treatment
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* Other: Cease progsterone at 5
* Other: control group: progesterone 8


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Patients who had bleeding episodes before their first US because they are likely to continue P4 therapy without medical indication.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Progesterone 5 Weeks<br>The study group stop receiving P4 on the day of their first US at 5 weeks pregnancy | Other: Cease progsterone at 5<br>* Cease administration of progsterone at first US at 5 weeks<br>|
| Other: Control Group : P4 8 weeks<br>Progesterone will be given until 8 weeks of pregnancy | Other: control group: progesterone 8<br>* Control group: progesterone until 8 weeks of pregnancy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progesterone | 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. | june 2009 |