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Early Progesterone Cessation After in Vitro Fertilization

This study has been completed.
Sponsor:
Information provided by:
Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier:
NCT01177904
First received: August 5, 2010
Last updated: March 16, 2011
Last verified: March 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
All Patients Which Show a Gestational Sac in Their Uterus in the First US Are Included in This Study and Randomized.
 Other: Cease progsterone at 5
Other: control group: progesterone 8
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early Progesterone Cessation After in Vitro Fertilization

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Instituto Valenciano de Infertilidad, Spain:

Primary Outcome Measures:
  • progesterone [ Time Frame: june 2009 ] [ Designated as safety issue: No ]

    Our predictions are similar to those seen in previous studies:

    No significant change in the miscarriage rate.

    There may be a higher percentage of bleeding episodes in patients who stop LPS earlier, but it does not seem to have an impact.



Estimated Enrollment: 220
Study Start Date: January 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Progesterone 5 Weeks
The study group stop receiving P4 on the day of their first US at 5 weeks pregnancy
 Other: Cease progsterone at 5
Cease administration of progsterone at first US at 5 weeks
Control Group : P4 8 weeks
Progesterone will be given until 8 weeks of pregnancy
 Other: control group: progesterone 8
Control group: progesterone until 8 weeks of pregnancy

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01177904

Locations
Spain
IVI-Madrid
Madrid, Spain, 28023
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, Spain
Investigators
Study Director: Juan A Garcia-Velasco, MD, PhD IVI Madrid
  More Information

No publications provided by Instituto Valenciano de Infertilidad, Spain

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Early progesterone cessation after in vitro fertilization, IVI Madrid
ClinicalTrials.gov Identifier: NCT01177904     History of Changes
Other Study ID Numbers: MAD-GK-01-2009-02
Study First Received: August 5, 2010
Last Updated: March 16, 2011
Health Authority: Spain: Comité Ético de Investigación Clínica

Additional relevant MeSH terms:
Progesterone
Progestins
Hormones
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013