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Low Dose hCG in the Late Follicular Phase

NCT ID: NCT00750100

Last Updated: 2010-10-11

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

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-11-30

Brief Summary

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In this study,the investigators compared two protocols for controlled ovarian hyperstimulation in infertility patients requiring IVF. In the control group, the patient undergoes a standard antagonist protocol. In the study group, the administration of gonadotropins is stopped in the late follicular phase and replaced by low dose human chorionic gonadotropins. The primary endpoint of the study is the number of oocytes retrieved in both groups.

Detailed Description

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Conditions

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Infertility

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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A

Patients undergo a standard antagonist protocol for in-vitro fertilisation, and are stimulated with recombinant gonadotropins.

Group Type ACTIVE_COMPARATOR

recombinant gonadotropins

Intervention Type DRUG

200 IU per day during controlled ovarian stimulation

B

Patients are undergo an antagonist protocol for in-vitro fertilisation and are stimulated with recombinant gonadotropins. When the patient has an estradiol value of 600 ng/L or more and when the patient has at least 6 follicles of 12 mm, the administration of gonadotropins is stopped and replaced by low dose human chorionic gonadotropins.

Group Type EXPERIMENTAL

human chorionic gonadotropin

Intervention Type DRUG

hCG 200IU in the late follicular phase

Interventions

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human chorionic gonadotropin

hCG 200IU in the late follicular phase

Intervention Type DRUG

recombinant gonadotropins

200 IU per day during controlled ovarian stimulation

Intervention Type DRUG

Other Intervention Names

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Pregnyl, NV Organon, Oss, The Netherlands Puregon, NV Organon, Oss, The Netherlands

Eligibility Criteria

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Inclusion Criteria

* \< 36 years on day of randomisation
* FSH \< 12 in the early follicular phase
* Normal ultrasound scan
* BMI between 18 and 29 (both inclusive)
* Randomisation at outpatient clinic

Exclusion Criteria

* Endometriosis ≥ grade 3
* PCO syndrome
* Poor responder
* Endocrine or metabolic abnormalities
Minimum Eligible Age

18 Years

Maximum Eligible Age

36 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Universitair Ziekenhuis Brussel

Principal Investigators

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Christophe Blockeel, MD

Role: PRINCIPAL_INVESTIGATOR

UZ Brussel, Centre for Reproductive Medicine, Brussels

Locations

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UZ Brussel

Laarbeeklaan 101, Brussels Capital, Belgium

Site Status

Countries

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Belgium

References

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Filicori M, Cognigni GE, Gamberini E, Parmegiani L, Troilo E, Roset B. Efficacy of low-dose human chorionic gonadotropin alone to complete controlled ovarian stimulation. Fertil Steril. 2005 Aug;84(2):394-401. doi: 10.1016/j.fertnstert.2005.02.036.

Reference Type BACKGROUND
PMID: 16084880 (View on PubMed)

Blockeel C, De Vos M, Verpoest W, Stoop D, Haentjens P, Devroey P. Can 200 IU of hCG replace recombinant FSH in the late follicular phase in a GnRH-antagonist cycle? A pilot study. Hum Reprod. 2009 Nov;24(11):2910-6. doi: 10.1093/humrep/dep253. Epub 2009 Jul 17.

Reference Type DERIVED
PMID: 19617207 (View on PubMed)

Other Identifiers

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EC REF 2006-157

Identifier Type: -

Identifier Source: org_study_id