Early Progesterone Cessation After in Vitro Fertilization

Not Applicable

Completed

• Conditions: Pregnant Women
• Interventions: Other: Cease progsterone at 5

• Registration Number: NCT01177904
• Lead Sponsor: IVI Madrid

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Study First Submitted: 2010-08-05
• Study First Submitted QC: 2010-08-06
• Study First Posted: 2010-08-09
• Results First Submitted: 2018-04-03
• Status Verified: 2024-04
• Results First Submitted QC: 2024-04-05
• Last Update Submitted: 2024-04-05
• Results First Posted: 2024-04-08
• Last Update Posted: 2024-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Progesterone 5 Weeks	Cease progsterone at 5	The study group stop receiving P4 on the day of their first US at 5 weeks pregnancy

Primary Outcome Measures

Name	Time	Method
Number of Bleeding Episodes	Up to year	Number of bleeding episodes up to a year

Trial Locations

Locations (1)

IVI-Madrid; 🇪🇸 Madrid, Spain