Back to resultsAntagonist Protocol in IVF
Primary Purpose
Infertility
Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Gonadotropins releasing hormone antagonist
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring infertility
Eligibility Criteria
Inclusion Criteria:
- age: 20- 44 years
- Poor responder females according to Bologna criteria
- Polycystic ovarian disease females according to Rotterdam criteria
- Females with infertility causes other than poor responders, or PCO; male factor or tubal block
Exclusion Criteria:
- refusal to get enrolled in the study
- cases of infertility due to severe male factor
Sites / Locations
- Kasr el aini hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Normal
Poor responders
Polycystic ovarian disease
Arm Description
Human menopausal gonadotrophin IM daily was administrated from day 2 of the cycle. The Gonadotropins releasing hormone antagonist GnRH ant (Cetrotide, Serono, Geneva, Switzerland) was given when the leading follicle was from 12 to 14 mm, at a daily dose of 0.25 mg SC.
Human menopausal gonadotrophin IM daily was administrated from day 2 of the cycle. The Gonadotropins releasing hormone antagonist GnRH ant (Cetrotide, Serono, Geneva, Switzerland) was given when the leading follicle was from 12 to 14 mm, at a daily dose of 0.25 mg SC
Human menopausal gonadotrophin IM daily was administrated from day 2 of the cycle. The Gonadotropins releasing hormone antagonist GnRH ant(Cetrotide, Serono, Geneva, Switzerland) was given when the leading follicle was from 12 to 14 mm, at a daily dose of 0.25 mg SC
Outcomes
Primary Outcome Measures
number of oocytes collected and fertilized
Secondary Outcome Measures
Full Information
NCT ID
NCT02335736
First Posted
January 7, 2015
Last Updated
February 12, 2016
Sponsor
Woman's Health University Hospital, Egypt
Collaborators
Cairo University
1. Study Identification
Unique Protocol Identification Number
NCT02335736
Brief Title
Antagonist Protocol in IVF
Official Title
Can Antagonist Protocol be the Protocol of Choice in in Vitro Fertilization Patients?
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
April 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Woman's Health University Hospital, Egypt
Collaborators
Cairo University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The antagonist protocol in a novel method of stimulation in the in vitro fertilization (IVF) patients. It has been tried in poor responders, polycystic ovary (PCO) patients and normal females undergoing IVF. Can it be used with the same efficacy in all patients?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Normal
Arm Type
Active Comparator
Arm Description
Human menopausal gonadotrophin IM daily was administrated from day 2 of the cycle. The Gonadotropins releasing hormone antagonist GnRH ant (Cetrotide, Serono, Geneva, Switzerland) was given when the leading follicle was from 12 to 14 mm, at a daily dose of 0.25 mg SC.
Arm Title
Poor responders
Arm Type
Active Comparator
Arm Description
Human menopausal gonadotrophin IM daily was administrated from day 2 of the cycle. The Gonadotropins releasing hormone antagonist GnRH ant (Cetrotide, Serono, Geneva, Switzerland) was given when the leading follicle was from 12 to 14 mm, at a daily dose of 0.25 mg SC
Arm Title
Polycystic ovarian disease
Arm Type
Active Comparator
Arm Description
Human menopausal gonadotrophin IM daily was administrated from day 2 of the cycle. The Gonadotropins releasing hormone antagonist GnRH ant(Cetrotide, Serono, Geneva, Switzerland) was given when the leading follicle was from 12 to 14 mm, at a daily dose of 0.25 mg SC
Intervention Type
Drug
Intervention Name(s)
Gonadotropins releasing hormone antagonist
Other Intervention Name(s)
Cetrotide, Serono, Geneva, Switzerland
Primary Outcome Measure Information:
Title
number of oocytes collected and fertilized
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age: 20- 44 years
Poor responder females according to Bologna criteria
Polycystic ovarian disease females according to Rotterdam criteria
Females with infertility causes other than poor responders, or PCO; male factor or tubal block
Exclusion Criteria:
refusal to get enrolled in the study
cases of infertility due to severe male factor
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dina M Dakhly, MD
Phone
01003498919
Ext
002
Email
dinadakhly@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
mohamed abdalla, MD
Phone
01001721206
Ext
002
Email
mohamedhassan100@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dina M Dakhly, MD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr el aini hospital
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dina M Dakhly, MD
Phone
01003498919
Ext
002
Email
Dinadakhly@gmail.com
First Name & Middle Initial & Last Name & Degree
Dina M Dakhly, MD
12. IPD Sharing Statement
Learn more about this trial
Antagonist Protocol in IVF
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