Back to resultsEarly Preparation With Gonadotropin- Releasing Hormon (GnRh) Agonists Injection With Frozen-Thawed Embryo Transfer?
Primary Purpose
Infertility, Female
Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Triptorelin SR
Sponsored by
About this trial
This is an interventional treatment trial for Infertility, Female
Eligibility Criteria
Inclusion Criteria:infertile women with impaired ovulation -
Exclusion Criteria:
-
Sites / Locations
- Benha university hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
(Group A) Midluteal Triptorelin depot
(Group B)first day Triptorelin depot
Arm Description
infertile women with impaired ovulation who will be subjected to Triptorelin sustained release(Decapeptyl depot 375 mg one injection )at D-21 of previous menstrual cycle Hormon Replacement Therapy (HRT)Cyclo-Progynova (estradiol, norgestrel)(Group A). All patients received the same luteal support in the form of intravaginal progesterone two day before embryos transfer until blood pregnancy test was performed 14 days later. The classic Testart slow freezing and rapid thawing protocol was applied on stage-2 PN embryos. Endometrial thickness was measured in the midsagittal plane using transvaginal ultrasound (TVU). Clinical pregnancy was diagnosed by measurement of β-HCG level and was confirmed 2-weeks later by TVU.
infertile women with impaired ovulation who will be subjected toTriptorelin sustained release(Decapeptyl depot 375 mg one injection) at D-1 of menses then Cyclo-Progynova (estradiol, norgestrel) (Group B). All patients received the same luteal support in the form of intravaginal progesterone two day before embryos transfer until blood pregnancy test was performed 14 days later. The classic Testart slow freezing and rapid thawing protocol was applied on stage-2 PN embryos. Endometrial thickness was measured in the midsagittal plane using transvaginal ultrasound (TVU). Clinical pregnancy was diagnosed by measurement of β-Human Chorionic Gonadotropin level and was confirmed 2-weeks later by TVU.
Outcomes
Primary Outcome Measures
pregnancy outcome
pregnancy test-Transvaginal sonograghy
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03353883
Brief Title
Early Preparation With Gonadotropin- Releasing Hormon (GnRh) Agonists Injection With Frozen-Thawed Embryo Transfer?
Official Title
Is Early Preparation With GnRh Agonists Injection on D-1 of Menses of Hormonal Replacement Cycle Improves Pregnancy Rate in Women With Impaired Ovulation and Undergoing Frozen-Thawed Embryo Transfer? A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
August 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha 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
The study intended to include >200 infertile women with impaired ovulation who will be subjected to HRT at D-21 of previous menstrual cycle (Group A) or D-1 of menses of replacement cycle (Group B). All patients received the same luteal support in the form of intravaginal progesterone two day before embryos transfer until blood pregnancy test was performed 14 days later. Clinical pregnancy was diagnosed by measurement of β-human chorionic gonadotropin level and was confirmed 2-weeks later by TVU.
Detailed Description
The study intended to include >200 infertile women with impaired ovulation who will be subjected to HRT at D-21 of previous menstrual cycle (Group A) or D-1 of menses of replacement cycle (Group B). All patients received the same luteal support in the form of intravaginal progesterone two day before embryos transfer until blood pregnancy test was performed 14 days later. The classic Testart slow freezing and rapid thawing protocol was applied on stage-2 pronuclear embryos. Endometrial thickness was measured in the midsagittal plane using transvaginal ultrasound (TVU). Clinical pregnancy was diagnosed by measurement of β-human chorionic gonadotropin level and was confirmed 2-weeks later by TVU.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
sealed envelopes
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
(Group A) Midluteal Triptorelin depot
Arm Type
Active Comparator
Arm Description
infertile women with impaired ovulation who will be subjected to Triptorelin sustained release(Decapeptyl depot 375 mg one injection )at D-21 of previous menstrual cycle Hormon Replacement Therapy (HRT)Cyclo-Progynova (estradiol, norgestrel)(Group A). All patients received the same luteal support in the form of intravaginal progesterone two day before embryos transfer until blood pregnancy test was performed 14 days later. The classic Testart slow freezing and rapid thawing protocol was applied on stage-2 PN embryos. Endometrial thickness was measured in the midsagittal plane using transvaginal ultrasound (TVU). Clinical pregnancy was diagnosed by measurement of β-HCG level and was confirmed 2-weeks later by TVU.
Arm Title
(Group B)first day Triptorelin depot
Arm Type
Active Comparator
Arm Description
infertile women with impaired ovulation who will be subjected toTriptorelin sustained release(Decapeptyl depot 375 mg one injection) at D-1 of menses then Cyclo-Progynova (estradiol, norgestrel) (Group B). All patients received the same luteal support in the form of intravaginal progesterone two day before embryos transfer until blood pregnancy test was performed 14 days later. The classic Testart slow freezing and rapid thawing protocol was applied on stage-2 PN embryos. Endometrial thickness was measured in the midsagittal plane using transvaginal ultrasound (TVU). Clinical pregnancy was diagnosed by measurement of β-Human Chorionic Gonadotropin level and was confirmed 2-weeks later by TVU.
Intervention Type
Drug
Intervention Name(s)
Triptorelin SR
Other Intervention Name(s)
Decapeptyl
Intervention Description
GnRH agonist depot( Decapeptyl) will be taken in the previous mid luteal cycle in group A and the first day in group B
Primary Outcome Measure Information:
Title
pregnancy outcome
Description
pregnancy test-Transvaginal sonograghy
Time Frame
4 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:infertile women with impaired ovulation -
Exclusion Criteria:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Khalid M Salama
Phone
01225861026
Email
dr.khalid_sleem@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hesham M Abo Ragab
Phone
01002599027
Email
ahmed-1919@windowslive.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khalid M Salama, MD
Organizational Affiliation
Associate professor of obestetric and gynecology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Benha university hospital
City
Banhā
State/Province
Qaluibia
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
khalid M salama, MD
Phone
01225861026
Email
dr.khalid_sleem@yahoo.com
First Name & Middle Initial & Last Name & Degree
khalid M salama, MD
Phone
01225861026
Email
d.khalid_sleem@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25904960
Citation
Azimi Nekoo E, Chamani M, Shahrokh Tehrani E, Hossein Rashidi B, Davari Tanha F, Kalantari V. Artificial Endometrial Preparation for Frozen-Thawed Embryo Transfer with or without Pretreatment with Depot Gonadotropin Releasing Hormone Agonist in Women with Regular Menses. J Family Reprod Health. 2015 Mar;9(1):1-4.
Results Reference
result
Links:
URL
http://bu.edu.eg
Description
infertility
Learn more about this trial
Early Preparation With Gonadotropin- Releasing Hormon (GnRh) Agonists Injection With Frozen-Thawed Embryo Transfer?
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