Back to resultsEvaluation of the Luteolytic Effect of a Gonadotropin Releasing Hormone (GnRH) Agonist After the Administration of Human Chorionic Gonadotropin (hCG) in the Initial Follicular Phase a Its Influence on the Prognosis of in Vitro Fertilization Treatment
Primary Purpose
Infertility
Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
GnRH agonist
Control
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring corpus luteum rescue, Gonadotropin Releasing Hormone (GnRH agonist), human Chorionic Gonadotropin (hCG), infertility, pregnancy rate
Eligibility Criteria
Inclusion Criteria:
- age >21 and < 38 years old
- polycystic ovarian syndrome
- risk for ovarian hyperstimulation syndrome
Exclusion Criteria:
- recurrent abortion
- endometriosis
- more than 3 IVF failures
- use of oral contraceptive pills in the preceding 3 months
- low response to gonadotropins
Sites / Locations
- Assisted Reproduction Center "Governor Mário Covas" of the Faculty of Medicine of the University of São PauloRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
GnRH agonist
Control
Arm Description
3,6 mg of goserelin acetate (GnRH agonist) will be administered on the 21st day of the menstrual cycle previous to ovarian stimulation. 250 mg of hCG will be administered on the first day of menses and a starting dose of 150 IU of FSH will be started 2 days later as a part of a long ovarian stimulation protocol. Ovulation will be triggered with a 250 mg of hCG when at least 2 follicles attain 18mm and to accommodate oocyte retrieval within 36 hours.
250 mg of hCG will be administered on the first day of menses and a starting dose of 150 IU of FSH will be started 2 days later as a part of a long ovarian stimulation protocol. Ovulation will be triggered with a 250 mg of hCG when at least 2 follicles attain 18mm and to accommodate oocyte retrieval within 36 hours.
Outcomes
Primary Outcome Measures
Frequency of functional rescue of corpus luteum
Secondary Outcome Measures
Pregnancy rate
Levels of serum steroids
Levels of serum gonadotropins
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00948805
Brief Title
Evaluation of the Luteolytic Effect of a Gonadotropin Releasing Hormone (GnRH) Agonist After the Administration of Human Chorionic Gonadotropin (hCG) in the Initial Follicular Phase a Its Influence on the Prognosis of in Vitro Fertilization Treatment
Official Title
Evaluation of the Luteolytic Effect of a Gonadotropin Releasing Hormone (GnRH) Agonist After the Administration of Human Chorionic Gonadotropin (hCG) in the Initial Follicular Phase a Its Influence on the Prognosis of in Vitro Fertilization Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
July 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study was designed to evaluate the ability of gonadotropin releasing hormone (GnRh) agonist to prevent the rise of progesterone during controlled ovarian stimulation for in vitro fertilization (IVF) after the administration of human Chorionic Gonadotropin (hCG) on the first day of menses.
Detailed Description
The aim of this study is to evaluate the efficacy of a GnRH agonist in preventing the functional rescue of corpus luteum in women submitted to controlled ovarian stimulation with administration of hCG on the first day of menses and to evaluate its effect on pregnancy rate and ovarian steroidogenesis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
corpus luteum rescue, Gonadotropin Releasing Hormone (GnRH agonist), human Chorionic Gonadotropin (hCG), infertility, pregnancy rate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
GnRH agonist
Arm Type
Experimental
Arm Description
3,6 mg of goserelin acetate (GnRH agonist) will be administered on the 21st day of the menstrual cycle previous to ovarian stimulation. 250 mg of hCG will be administered on the first day of menses and a starting dose of 150 IU of FSH will be started 2 days later as a part of a long ovarian stimulation protocol. Ovulation will be triggered with a 250 mg of hCG when at least 2 follicles attain 18mm and to accommodate oocyte retrieval within 36 hours.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
250 mg of hCG will be administered on the first day of menses and a starting dose of 150 IU of FSH will be started 2 days later as a part of a long ovarian stimulation protocol. Ovulation will be triggered with a 250 mg of hCG when at least 2 follicles attain 18mm and to accommodate oocyte retrieval within 36 hours.
Intervention Type
Drug
Intervention Name(s)
GnRH agonist
Other Intervention Name(s)
Ovidrel, Zoladex, Gonal
Intervention Description
3,6mg of goserelin acetate, 250mg of hCG, FSH variable dose according to the number of days required for appropriate ovarian stimulation
Intervention Type
Drug
Intervention Name(s)
Control
Other Intervention Name(s)
Zoladex, Ovidrel, Gonal
Intervention Description
250mg of hCG, Zoladex, FSH variable dose according to the number of days required for appropriate ovarian stimulation
Primary Outcome Measure Information:
Title
Frequency of functional rescue of corpus luteum
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Pregnancy rate
Time Frame
6 months
Title
Levels of serum steroids
Time Frame
6 months
Title
Levels of serum gonadotropins
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age >21 and < 38 years old
polycystic ovarian syndrome
risk for ovarian hyperstimulation syndrome
Exclusion Criteria:
recurrent abortion
endometriosis
more than 3 IVF failures
use of oral contraceptive pills in the preceding 3 months
low response to gonadotropins
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cláudia M Gomes, MD
Phone
551130596122
Email
cgomes@huntington.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
André M Rocha, PhD
Phone
551130596122
Email
arocha@huntington.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paulo Serafini, PhD
Organizational Affiliation
Gynecology of Faculty of Medicine of University of SãoPaulo (Disciplina de Ginecologia da Faculdade de Medicina da Universidade de São Paulo)
Official's Role
Study Chair
Facility Information:
Facility Name
Assisted Reproduction Center "Governor Mário Covas" of the Faculty of Medicine of the University of São Paulo
City
São Paulo
ZIP/Postal Code
05403000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cláudia Gomes, MD
Phone
551176569373
Email
cgomes@huntington.com.br
First Name & Middle Initial & Last Name & Degree
Cláudia Gomes, MD
12. IPD Sharing Statement
Links:
URL
http://www.fm.usp.br
Description
University of São Paulo web page
Learn more about this trial
Evaluation of the Luteolytic Effect of a Gonadotropin Releasing Hormone (GnRH) Agonist After the Administration of Human Chorionic Gonadotropin (hCG) in the Initial Follicular Phase a Its Influence on the Prognosis of in Vitro Fertilization Treatment
We'll reach out to this number within 24 hrs