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Low Dose Human Chorionic Gonadotropin: Influence on the Endometrium

Primary Purpose

Infertility

Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
human menopausal gonadotropin
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring infertility, ICSI, hCG, infertility treatment

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

Recombinant FSH

human chorionic gonadotropin

Arm Description

Patients undergo a standard antagonist protocol for in-vitro fertilisation, and are stimulated with recombinant gonadotropins. Histology and gene expression is studied on the endometrium.

Patients 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. Histology and gene expression is studied on the endometrium

Outcomes

Primary Outcome Measures

number of oocytes

Secondary Outcome Measures

Full Information

First Posted
September 11, 2009
Last Updated
March 24, 2010
Sponsor
Universitair Ziekenhuis Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT00976651
Brief Title
Low Dose Human Chorionic Gonadotropin: Influence on the Endometrium
Official Title
Influence of Ovarian Stimulation With 200 IU of hCG, (Administered in the Late Follicular Phase Among ICSI Patients Undergoing a GnRH-antagonist Protocol), on the Endometrium on the Day of Oocyte Pick-up
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Universitair Ziekenhuis Brussel

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the present study is to assess the influence of the administration of low dose hCG on the endometrium. The study is a randomised trial where 2 groups of patients, undergoing a gonadotropin-releasing hormone antagonist protocol for in vitro fertilization, are studied. In addition to the histological findings, by analysing the correlation of the morphological pattern and gene expression profile of human endometrium on the day of oocyte retrieval in patients of both treatment groups, the investigators want to study the implantation potential.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
infertility, ICSI, hCG, infertility treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Recombinant FSH
Arm Type
Active Comparator
Arm Description
Patients undergo a standard antagonist protocol for in-vitro fertilisation, and are stimulated with recombinant gonadotropins. Histology and gene expression is studied on the endometrium.
Arm Title
human chorionic gonadotropin
Arm Type
Experimental
Arm Description
Patients 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. Histology and gene expression is studied on the endometrium
Intervention Type
Drug
Intervention Name(s)
human menopausal gonadotropin
Intervention Description
200 IU per day in the late follicular phase
Primary Outcome Measure Information:
Title
number of oocytes
Time Frame
2 weeks after start of the treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
No
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
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
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
result

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Low Dose Human Chorionic Gonadotropin: Influence on the Endometrium

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