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OpenTrials
Completed

NCT Number: NCT01177904

Early Progesterone Cessation After in Vitro Fertilization

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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Key information

Conditions

Pregnant Women

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

IVI-Madrid

Madrid, 28023, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cease progsterone at 5

Other

Cease administration of progsterone at first US at 5 weeks

control group: progesterone 8

Other

Control group: progesterone until 8 weeks of pregnancy

Primary outcomes

  1. Number of Bleeding Episodes

    Time frame: Up to year

    Number of bleeding episodes up to a year

Sponsors and collaborators

Lead sponsor

IVI Madrid

Other

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 9, 2010
Registry last updated
Apr 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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