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Low Dose hCG in the Late Follicular Phase

Primary Purpose

Infertility

Status

Completed

Phase

Phase 4

Locations

Belgium

Study Type

Interventional

Intervention

human chorionic gonadotropin

recombinant gonadotropins

About this trial

This is an interventional treatment trial for Infertility focused on measuring infertility, IVF, hCG, primary infertility, secondary infertility, patients requiring in-vitro fertilisation

Eligibility Criteria

18 Years - 36 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

UZ Brussel

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Number of oocytes in both treatment groups

Secondary Outcome Measures

Duration of stimulation in both treatment groups, amount of gonadotropins consumed in each treatment group

Full Information

NCT ID

NCT00750100

First Posted

September 9, 2008

Last Updated

October 8, 2010

Sponsor

Universitair Ziekenhuis Brussel

1. Study Identification

Unique Protocol Identification Number

NCT00750100

Brief Title

Low Dose hCG in the Late Follicular Phase

Official Title

Among ICSI Patients Undergoing Antagonist Protocols With Recombinant FSH, Does Replacement of Recombinant FSH by 200 IU of hCG in the Late Follicular Phase Compared With Continuing Recombinant FSH, Result in a Similar Number of Oocytes?

Study Type

Interventional

2. Study Status

Record Verification Date

September 2008

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

January 2008 (Actual)

Study Completion Date

November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Universitair Ziekenhuis Brussel

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility

Keywords

infertility, IVF, hCG, primary infertility, secondary infertility, patients requiring in-vitro fertilisation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

human chorionic gonadotropin

Other Intervention Name(s)

Pregnyl, NV Organon, Oss, The Netherlands

Intervention Description

hCG 200IU in the late follicular phase

Intervention Type

Drug

Intervention Name(s)

recombinant gonadotropins

Other Intervention Name(s)

Puregon, NV Organon, Oss, The Netherlands

Intervention Description

200 IU per day during controlled ovarian stimulation

Primary Outcome Measure Information:

Title

Number of oocytes in both treatment groups

Time Frame

up to 9 months

Secondary Outcome Measure Information:

Title

Duration of stimulation in both treatment groups, amount of gonadotropins consumed in each treatment group

Time Frame

up to 9 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

36 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christophe Blockeel, MD

Organizational Affiliation

UZ Brussel, Centre for Reproductive Medicine, Brussels

Official's Role

Principal Investigator

Facility Information:

Facility Name

UZ Brussel

City

Laarbeeklaan 101

State/Province

Brussels

ZIP/Postal Code

1090

Country

Belgium

12. IPD Sharing Statement

Citations:

PubMed Identifier

16084880

Citation

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.

Results Reference

background

PubMed Identifier

19617207

Citation

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.

Results Reference

derived

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Low Dose hCG in the Late Follicular Phase

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