Early Progesterone Cessation After in Vitro Fertilization

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-01-31

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.

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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:

1. Patients who underwent ovarian stimulation using GnRH analogues,
2. Fresh embryo transfer,
3. LPS by vaginal micronized P4,
4. Clinical pregnancy demonstrated by US and
5. 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.

Conditions

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Pregnant Women

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Progesterone 5 Weeks

The study group stop receiving P4 on the day of their first US at 5 weeks pregnancy

Group Type ACTIVE_COMPARATOR

Cease progsterone at 5

Intervention Type OTHER

Cease administration of progsterone at first US at 5 weeks

Control Group : P4 8 weeks

Progesterone will be given until 8 weeks of pregnancy

Group Type OTHER

control group: progesterone 8

Intervention Type OTHER

Control group: progesterone until 8 weeks of pregnancy

Interventions

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Cease progsterone at 5

Cease administration of progsterone at first US at 5 weeks

Intervention Type OTHER

control group: progesterone 8

Control group: progesterone until 8 weeks of pregnancy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Patients who underwent ovarian stimulation using GnRH analogues,
2. Fresh embryo transfer,
3. LPS by vaginal micronized P4,
4. Clinical pregnancy demonstrated by US and
5. Informed consent signed.