NCT01177904

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 9, 2010

Completed
13.7 years until next milestone

Results Posted

Study results publicly available

April 8, 2024

Completed
Last Updated

April 8, 2024

Status Verified

April 1, 2024

Enrollment Period

1 year

First QC Date

August 5, 2010

Results QC Date

April 3, 2018

Last Update Submit

April 5, 2024

Conditions

Pregnant Women

Outcome Measures

Primary Outcomes (1)

  • Number of Bleeding Episodes

    Number of bleeding episodes up to a year

    Up to year

Study Arms (2)

Progesterone 5 Weeks

ACTIVE COMPARATOR

The study group stop receiving P4 on the day of their first US at 5 weeks pregnancy

Other: Cease progsterone at 5

Control Group : P4 8 weeks

OTHER

Progesterone will be given until 8 weeks of pregnancy

Other: control group: progesterone 8

Interventions

Cease progsterone at 5OTHER

Cease administration of progsterone at first US at 5 weeks

Progesterone 5 Weeks
control group: progesterone 8OTHER

Control group: progesterone until 8 weeks of pregnancy

Control Group : P4 8 weeks

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients who had bleeding episodes before their first US because they are likely to continue P4 therapy without medical indication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IVI-Madrid

Madrid, 28023, Spain

Location

Related Publications (1)

  • Kohls G, Ruiz F, Martinez M, Hauzman E, de la Fuente G, Pellicer A, Garcia-Velasco JA. Early progesterone cessation after in vitro fertilization/intracytoplasmic sperm injection: a randomized, controlled trial. Fertil Steril. 2012 Oct;98(4):858-62. doi: 10.1016/j.fertnstert.2012.05.046. Epub 2012 Jun 29.

    PMID: 22749223DERIVED

Results Point of Contact

Title
Dr. Graciela Kohls
Organization
IVI Madrid
graciela.kohls@ivi.es
91 180 29 00

Study Officials

  • Juan A Garcia-Velasco, MD, PhD

    IVI Madrid

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gynecologist

Study Record Dates

First Submitted

August 5, 2010

First Posted

August 9, 2010

Study Start

January 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

April 8, 2024

Results First Posted

April 8, 2024

Record last verified: 2024-04

Locations

ES(1)