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

NCT ID: NCT00954811

Last Updated: 2010-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pregnancy Pregnancy Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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HCG for ovulation triggering and luteal progesterone

conventional triggering with HCG and conventional luteal support with progesterone

Group Type ACTIVE_COMPARATOR

progesterone 600mg

Intervention Type DRUG

luteal support

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

Group Type EXPERIMENTAL

300IU rec-LH

Intervention Type DRUG

luteal alternate doses

Interventions

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300IU rec-LH

luteal alternate doses

Intervention Type DRUG

progesterone 600mg

luteal support

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* endometriosis,
* 3 and 4,
* pco,
* frozen sperm
Minimum Eligible Age

20 Years

Maximum Eligible Age

36 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Merck Serono International SA

INDUSTRY

Sponsor Role collaborator

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Centre for Reproductive Medicine,UZ Brussel

Principal Investigators

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Paul Devroey

Role: STUDY_CHAIR

Professor or OB-GYN

Locations

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Centre for Reproductive Medicine, UZ Brussel

Brussels, Jette, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Evangelos Papanikolaou, PhD

Role: CONTACT

Facility Contacts

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Evangelos Papanikolaou, MD,PhD

Role: primary

0032 2 4776606

Other Identifiers

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recombinant LH 1505

Identifier Type: -

Identifier Source: org_study_id

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