Back to resultsDydrogesterone-Primed Ovarian Stimulation Protocol Versus Gonadotropin Releasing Hormone Antagonist Protocol in ICSI
Primary Purpose
Ovary Cyst, Fertility Issues
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
progestin primed ovarian stimulation protocol
dydrogesterone (Duphaston, Abbott)
Cetrotide
Sponsored by
About this trial
This is an interventional treatment trial for Ovary Cyst focused on measuring IVF,ICSI,success rate
Eligibility Criteria
Inclusion Criteria: All patients should be candidates for ICSI. Age between 20-40 years. Body mass index 18-35 kg/m2. Diagnosis of PCOS according to modified Rotterdam's criteria Exclusion Criteria: 1) Any patient with contraindication to IVF treatment or pregnancy 2) Women with history of intra-uterine abnormality. 3) Severe endometriosis (grade 3 or 4) 4) Clinically significant systemic disease or other endocrinopathy.
Sites / Locations
- Zagazig UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group (A)
group (B)
Arm Description
will be subjected to progestin primed ovarian stimulation protocol Women in group (A), will be prescribed 20 mg oral dose of dydrogesterone (Duphaston, Abbott) from the 2nd day of the cycle and continued until the trigger day. Transvaginal follicular monitoring will be done for all patients starting the 6th day of cycle.
Gonadotropin Releasing Hormone Antagonist Protocol when the size of dominant follicles reaches 12-13 mm, 0.25 mg of cetrotide (Merck-Serono Germany) will be injected subcutaneously daily and continued until the day of trigger shot.
Outcomes
Primary Outcome Measures
Efficacy (Number of MII oocytes retrieved)
this outcome means to measure Percentage (number) of MII oocytes retrieved During our study
Efficacy (Maturation index)
Maturation index will be calculated: Rate of metaphase-II oocytes (MII) to total oocytes
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05751681
Brief Title
Dydrogesterone-Primed Ovarian Stimulation Protocol Versus Gonadotropin Releasing Hormone Antagonist Protocol in ICSI
Official Title
Dydrogesterone-Primed Ovarian Stimulation Protocol Versus Gonadotropin Releasing Hormone Antagonist Protocol in Patients With Polycystic Ovary Syndrome Undergoing Intra-Cytoplasmic Sperm Injection
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2023 (Actual)
Primary Completion Date
April 20, 2024 (Anticipated)
Study Completion Date
March 20, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zagazig University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
GnRH antagonist protocol is currently a good strategy for controlled ovarian stimulation in women with PCOS undergoing IVF/ICSI cycles. Finding a protocol that can be a better alternative will help in improving the success rate of IVF/ICSI cycles
Detailed Description
Progesterone has potent restraint on hypothalamus-pituitary-ovarian axis. It acts on unidentified hypothalamic pulse oscillator neurons. In turn, it acts on gonadotropins releasing hormone (GnRH) secreting neurons leading to inhibition of GnRH secretion. This results in inhibition of both luteinizing hormone (LH) and follicle-stimulating hormone (FSH) secretion from anterior pituitary. The effect of progesterone appears to decrease GnRH pulse frequency which results in slowing down LH pulse frequency and reducing LH plasma concentrations
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovary Cyst, Fertility Issues
Keywords
IVF,ICSI,success rate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
79 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group (A)
Arm Type
Experimental
Arm Description
will be subjected to progestin primed ovarian stimulation protocol Women in group (A), will be prescribed 20 mg oral dose of dydrogesterone (Duphaston, Abbott) from the 2nd day of the cycle and continued until the trigger day. Transvaginal follicular monitoring will be done for all patients starting the 6th day of cycle.
Arm Title
group (B)
Arm Type
Active Comparator
Arm Description
Gonadotropin Releasing Hormone Antagonist Protocol when the size of dominant follicles reaches 12-13 mm, 0.25 mg of cetrotide (Merck-Serono Germany) will be injected subcutaneously daily and continued until the day of trigger shot.
Intervention Type
Other
Intervention Name(s)
progestin primed ovarian stimulation protocol
Intervention Description
progestin primed ovarian stimulation protocol
Intervention Type
Drug
Intervention Name(s)
dydrogesterone (Duphaston, Abbott)
Intervention Description
20 mg oral dose of dydrogesterone (Duphaston, Abbott)
Intervention Type
Drug
Intervention Name(s)
Cetrotide
Other Intervention Name(s)
cetrorelix
Intervention Description
0.25 mg of Cetrotide (gonadotropin releasing hormone (GnRH) antagonist)
Primary Outcome Measure Information:
Title
Efficacy (Number of MII oocytes retrieved)
Description
this outcome means to measure Percentage (number) of MII oocytes retrieved During our study
Time Frame
3 months
Title
Efficacy (Maturation index)
Description
Maturation index will be calculated: Rate of metaphase-II oocytes (MII) to total oocytes
Time Frame
3 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
20-40 years
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients should be candidates for ICSI.
Age between 20-40 years.
Body mass index 18-35 kg/m2.
Diagnosis of PCOS according to modified Rotterdam's criteria
Exclusion Criteria:
1) Any patient with contraindication to IVF treatment or pregnancy 2) Women with history of intra-uterine abnormality. 3) Severe endometriosis (grade 3 or 4) 4) Clinically significant systemic disease or other endocrinopathy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mostafa fahmy, mcs
Phone
01065644434
Email
mafahmy21@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mostafa fahmy, mcs
Organizational Affiliation
zagazig
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zagazig University
City
Zagazig
ZIP/Postal Code
44511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mustapha fahmy, mcs
Phone
01065644434
Email
mafahmy21@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Dydrogesterone-Primed Ovarian Stimulation Protocol Versus Gonadotropin Releasing Hormone Antagonist Protocol in ICSI
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