Early Progesterone Cessation After in Vitro Fertilization

IVI Madrid

Status: Completed

Conditions: Pregnant Women

Treatments: Other: Cease progsterone at 5; Other: control group: progesterone 8

Study type: Interventional

Funder types: Other

Identifiers

NCT01177904

MAD-GK-01-2009-02

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Progesterone 5 Weeks

Active Comparator group

Description:

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

Treatment:

Other: Cease progsterone at 5

Control Group : P4 8 weeks

Other group

Description:

Progesterone will be given until 8 weeks of pregnancy

Treatment:

Other: control group: progesterone 8