Back to resultsFreeze All on Oocyte Maturatin by Gonadotropin Agonist Versus Human Chorionic Gonadotroipin
Primary Purpose
Infertility
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Agonist (decapeptyl )
HCG ( eg. Choriomon )
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility Criteria
Inclusion Criteria:
- PCOS patients according to Rotterdam criteria
- Female age between 20 and 40 years.
- Primary or secondary infertility.
- Body mass index (BMI) between 18 and 40 kg/m2.
Exclusion Criteria:
Ovarian endometriosis.
- Ovarian cysts before induction.
- Known uncontrolled endocrinal abnormalities (like hypo or hyperthyroidism)
Sites / Locations
- Aljazeera( Al Gazeera) hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
giving agonist ( eg. decapeptyl )
Giving HCG (eg. choriomon )
Arm Description
Giving women agonist
Giving women HCG
Outcomes
Primary Outcome Measures
the number of good quality embryos
how many good quality embryos
Secondary Outcome Measures
Full Information
NCT ID
NCT04749979
First Posted
January 29, 2021
Last Updated
February 10, 2021
Sponsor
Aljazeera Hospital
Collaborators
Cairo University
1. Study Identification
Unique Protocol Identification Number
NCT04749979
Brief Title
Freeze All on Oocyte Maturatin by Gonadotropin Agonist Versus Human Chorionic Gonadotroipin
Official Title
Freeze All on Oocyte Maturatin by Gonadotropin Agonist Versus Human Chorionic Gonadotroipin in IVF Cycles
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 5, 2021 (Anticipated)
Primary Completion Date
June 25, 2021 (Anticipated)
Study Completion Date
July 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aljazeera Hospital
Collaborators
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Estradiol valerate in the form of cycloprogenova™ (white tablet only) was started on day 2 or 3 of cycle with oral dose 4 mg divided on 2 doses in addition to Aspocid 75 mg once daily with folic acid 500 mcg once daily.
Detailed Description
U/S was done on day 9 or 10 of cycle to assess endometrial thickness, then every other day until endometrial thickness of 8 mm or more is reached and when endometrial thickness reaches 8 mm or more FET was planned. Progesterone in the form of prontogest™ 400 mg vaginal suppository twice dTwo to Four Day 5 Embryos was transferred
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
giving agonist ( eg. decapeptyl )
Arm Type
Active Comparator
Arm Description
Giving women agonist
Arm Title
Giving HCG (eg. choriomon )
Arm Type
Active Comparator
Arm Description
Giving women HCG
Intervention Type
Drug
Intervention Name(s)
Agonist (decapeptyl )
Intervention Description
giving agonist
Intervention Type
Drug
Intervention Name(s)
HCG ( eg. Choriomon )
Intervention Description
giving HCG
Primary Outcome Measure Information:
Title
the number of good quality embryos
Description
how many good quality embryos
Time Frame
within 5 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
females candidate for ICSI
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
PCOS patients according to Rotterdam criteria
Female age between 20 and 40 years.
Primary or secondary infertility.
Body mass index (BMI) between 18 and 40 kg/m2.
Exclusion Criteria:
Ovarian endometriosis.
Ovarian cysts before induction.
Known uncontrolled endocrinal abnormalities (like hypo or hyperthyroidism)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud Alalfy
Phone
01002611058
Email
mahmoudalalfy@ymail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud Alalfy, PhD
Organizational Affiliation
Algezeera hospitaland National Research Centre ,Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aljazeera( Al Gazeera) hospital
City
Giza
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahmoud Alalfy, PhD
Phone
+201002611058
Ext
+2
Email
mahmoudalalfy@ymail.com
12. IPD Sharing Statement
Learn more about this trial
Freeze All on Oocyte Maturatin by Gonadotropin Agonist Versus Human Chorionic Gonadotroipin
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