NCT00954811

Brief Summary

Our aim is to access whether we can achieve equivalent pregnancy rates by the addition of six doses of luteal support with recLH after agonist triggering for IVF cycles in the absence of OHSS.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for phase_4 pregnancy

Timeline
Completed

Started Sep 2005

Longer than P75 for phase_4 pregnancy

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2009

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

January 8, 2010

Status Verified

August 1, 2009

Enrollment Period

2.3 years

First QC Date

August 6, 2009

Last Update Submit

January 7, 2010

Conditions

PregnancyPregnancy Loss

Keywords

pregnancy

Outcome Measures

Primary Outcomes (1)

  • pregnancy occurrence, pregnancy loss

    14 days after OPU

Secondary Outcomes (1)

  • hormone levels, OHSS, endometrium

    14 days after oocyte pick up

Study Arms (2)

HCG for ovulation triggering and luteal progesterone

ACTIVE COMPARATOR

conventional triggering with HCG and conventional luteal support with progesterone

Drug: progesterone 600mg

Agonist triggering and rec-LH luteal support plus progesterone

EXPERIMENTAL

new method of triggering with GnRH-agonist and proof of concept intervention with novel way of luteal support with rec-LH plus the usual co-treatment with progesterone

Drug: 300IU rec-LH

Interventions

300IU rec-LHDRUG

luteal alternate doses

Agonist triggering and rec-LH luteal support plus progesterone
progesterone 600mgDRUG

luteal support

HCG for ovulation triggering and luteal progesterone

Eligibility Criteria

Age20 Years - 36 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \< 36years,
  • single blastocystET,
  • FSH \< 12

You may not qualify if:

  • endometriosis,
  • and 4,
  • pco,
  • frozen sperm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Reproductive Medicine, UZ Brussel

Brussels, Jette, 1090, Belgium

RECRUITING

MeSH Terms

Interventions

Progesterone

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCorpus Luteum HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsProgesterone CongenersGonadal Steroid Hormones

Study Officials

  • Paul Devroey

    Professor or OB-GYN

    STUDY CHAIR

Central Study Contacts

Evangelos Papanikolaou, PhD

CONTACT

drvagpapanikolaou@yahoo.gr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 6, 2009

First Posted

August 7, 2009

Study Start

September 1, 2005

Primary Completion

January 1, 2008

Study Completion

December 1, 2010

Last Updated

January 8, 2010

Record last verified: 2009-08

Locations

BE(1)