Luteal Supplementation With Rec-LH After GnRH-agonist Triggering in In Vitro (IVF)

January 7, 2010 updated by: Universitair Ziekenhuis Brussel

A Phase IV Study on the Effect of Luteal Supplementation With Rec-LH on the Pregnancy Rate After Ovulation Triggering With GnRH-agonist Instead of HCG in IVF Protocol;Proof of Concept

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Whether pregnancy outcome after GnRH-agonist triggering could be improved by adding luteal recLH support plus progesterone, compared to that observed after ovulation triggering with HCG in GnRH antagonist stimulated cycles.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Jette
      • Brussels, Jette, Belgium, 1090
        • Recruiting
        • Centre for Reproductive Medicine, UZ Brussel
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 36 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: HCG for ovulation triggering and luteal progesterone
conventional triggering with HCG and conventional luteal support with progesterone
Drug: progesterone 600mg
luteal support
EXPERIMENTAL: Agonist triggering and rec-LH luteal support plus progesterone
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
luteal alternate doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pregnancy occurrence, pregnancy loss
Time Frame: 14 days after OPU
14 days after OPU

Secondary Outcome Measures

Outcome Measure
Time Frame
hormone levels, OHSS, endometrium
Time Frame: 14 days after oocyte pick up
14 days after oocyte pick up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitair Ziekenhuis Brussel

Collaborators

Merck Serono International SA

Investigators

  • Study Chair: Paul Devroey, Professor or OB-GYN

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (ANTICIPATED)

January 1, 2008

Study Completion (ANTICIPATED)

December 1, 2010

Study Registration Dates

First Submitted

August 6, 2009

First Submitted That Met QC Criteria

August 6, 2009

First Posted (ESTIMATE)

August 7, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

January 8, 2010

Last Update Submitted That Met QC Criteria

January 7, 2010

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • recombinant LH 1505

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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