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Early Progesterone Cessation After in Vitro Fertilization

Information source: Instituto Valenciano de Infertilidad, IVI VALENCIA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: All Patients Which Show a Gestational Sac in Their Uterus in the First US Are Included in This Study and Randomized.

Intervention: Cease progsterone at 5 (Other); control group: progesterone 8 (Other)

Phase: Phase 4

Status: Completed

Sponsored by: Instituto Valenciano de Infertilidad, IVI VALENCIA

Official(s) and/or principal investigator(s):
Juan A Garcia-Velasco, MD, PhD, Study Director, Affiliation: IVI Madrid

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.

Clinical Details

Official title: Early Progesterone Cessation After in Vitro Fertilization

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: progesterone

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

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.

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.

Locations and Contacts

IVI-Madrid, Madrid 28023, Spain
Additional Information

Starting date: January 2009
Last updated: March 16, 2011

Page last updated: August 23, 2015

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