Early Progesterone Cessation After in Vitro Fertilization

Pregnant Women Clinical Trial

Official title:

Early Progesterone Cessation After in Vitro Fertilization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01177904
• Other study ID #: MAD-GK-01-2009-02
• Status: Completed
• Phase: N/A
• Start date: January 2009
• Est. completion date: January 2010

Study information

• Verified date: April 2024
• Source: IVI Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pregnant Women

Intervention

Other:
• Cease progsterone at 5
Cease administration of progsterone at first US at 5 weeks
• control group: progesterone 8
Control group: progesterone until 8 weeks of pregnancy

Locations

Country	Name	City	State
Spain	IVI-Madrid	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
IVI Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Bleeding Episodes	Number of bleeding episodes up to a year	Up to year