Low Dose Human Chorionic Gonadotropin: Influence on the Endometrium
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Infertility |
Drug: human menopausal gonadotropin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| 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 |
- number of oocytes [ Time Frame: 2 weeks after start of the treatment ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | January 2009 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Recombinant FSH
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.
|
Drug: human menopausal gonadotropin
200 IU per day in the late follicular phase
|
|
Experimental: human chorionic gonadotropin
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 |
Drug: human menopausal gonadotropin
200 IU per day in the late follicular phase
|
Eligibility| Ages Eligible for Study: | 18 Years to 36 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Publications:
| Responsible Party: | Paul Devroey, Universitair Ziekenhuis Brussel |
| ClinicalTrials.gov Identifier: | NCT00976651 History of Changes |
| Other Study ID Numbers: | CBLD2 |
| Study First Received: | September 11, 2009 |
| Last Updated: | March 24, 2010 |
| Health Authority: | Belgium: Institutional Review Board |
Keywords provided by Universitair Ziekenhuis Brussel:
|
infertility ICSI hCG infertility treatment |
Additional relevant MeSH terms:
|
Infertility Genital Diseases, Male Genital Diseases, Female Chorionic Gonadotropin Menotropins Reproductive Control Agents |
Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Fertility Agents, Female Fertility Agents |
ClinicalTrials.gov processed this record on May 23, 2013