The Effect of Luteinizing Hormone (LH) Supplementation Following Gonadotropin-releasing Hormone (GnRH) Antagonist Administration in Advanced Reproductive Ageing Women Undergoing IVF and Embryo Transfer (IVF/ET)

NCT ID: NCT01016210

Last Updated: 2014-01-17

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2013-04-30

Brief Summary

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To explore whether recombinant LH (rLH) supplementation (Leuveris) to recombinant follicle stimulating hormone (rFSH) following GnRH antagonist treatment has an advantage in infertile women with advanced reproductive ageing undergoing IVF-ET.

Detailed Description

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Conditions

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Pregnancy Result Rape

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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60 infertile women

Candidates for IVF-ET treatment

Group Type EXPERIMENTAL

Leuveris

Intervention Type DRUG

IV

Leuveris

Intervention Type DRUG

All recruited women will be treated similarly employing the recombinant FSH and the fixed GnRH antagonist. Concomitantly, on the same day of the antagonist administration r-LH will be administered daily and continued until human chorionic gonadotropin (hCG) day.

control

no treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Leuveris

IV

Intervention Type DRUG

Leuveris

All recruited women will be treated similarly employing the recombinant FSH and the fixed GnRH antagonist. Concomitantly, on the same day of the antagonist administration r-LH will be administered daily and continued until human chorionic gonadotropin (hCG) day.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* female candidate to IVF
* between 30-45 years old

Exclusion Criteria

* not included for fertilization
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ministry of Health, Israel

OTHER_GOV

Sponsor Role collaborator

The Baruch Padeh Medical Center, Poriya

OTHER_GOV

Sponsor Role lead

Responsible Party

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The baruch Padeh Medical center

Locations

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Poriya hospital

Tiberias, , Israel

Site Status

Countries

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Israel

Other Identifiers

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Leuveris1.CTIL

Identifier Type: -

Identifier Source: org_study_id

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