Dual Trigger Versus GnRHa Trigger Combined With Luteal HCG Administration
Primary Purpose
Infertility
Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
GnRHa and HCG
GnRHa then HCG (single low-dose)
GnRHa then HCG (multiple low-doses)
Sponsored by
About this trial
This is an interventional supportive care trial for Infertility focused on measuring GnRHa trigger, Luteal phase support, OHSS
Eligibility Criteria
Inclusion Criteria:
- Women subjected to ICSI through controlled ovarian hyperstimulation (COH) with pituitary downregulation by GnRH antagonist.
- Presence of risk for development of OHSS: 1) previous moderate or severe OHSS; 2) PCOS or polycystic ovary on ultrasound scan; 3) antral follicle count (AFC) > 14 in both ovaries; 4) basal serum AMH level > 3.36 ng/ml; 5) > 14 follicles with diameter of ≥ 11 mm on the day of triggering of oocyte maturation; 6) E2 level > 3000 pg/ml on the day of triggering of oocyte maturation.
Exclusion Criteria:
- Age < 20 years or > 35 years.
- BMI < 19 kg/m2 or > 35 kg/m2.
- Moderate or severe endometriosis.
- Hydrosalpinx.
- Uterine abnormalities or myoma.
- Previous uterine surgery.
- Use of alternative techniques to minimize the risk of OHSS.
Sites / Locations
- Fertility Care Unit (FCU) in Mansoura University HospitalRecruiting
- Private fertility care centersRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Dual trigger group
Single low-dose HCG group
Multiple low-doses HCG group
Arm Description
Trigger with concomitant GnRHa and HCG (single low-dose) administration
Trigger with GnRHa then HCG (single low-dose) administration in luteal phase
Trigger with GnRHa then HCG (multiple low-doses) administration in luteal phase
Outcomes
Primary Outcome Measures
Clinical pregnancy rate
Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 4-6 weeks after the ET) divided by the number of ET procedures
Secondary Outcome Measures
Oocyte maturation rate
Number of mature oocytes divided by the number of retrieved oocytes
Incidence of early OHSS
Incidence of OHSS within 9 days of final triggering of oocyte maturation
Implantation rate
Number of gestational sacs on TVS scan at 4-6 weeks after ET divided by the number of transferred embryos
Miscarriage rate
Number of first trimester miscarriages (before 12 weeks gestational age) divided by the number of clinical pregnancies
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02330770
Brief Title
Dual Trigger Versus GnRHa Trigger Combined With Luteal HCG Administration
Official Title
Dual Trigger Versus Gonadotropin Releasing Hormone Agonist Trigger Combined With Luteal Human Chorionic Gonadotropin Administration
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
March 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Comparing the reproductive outcomes of intracytoplasmic sperm injection (ICSI) cycles in women at risk of ovarian hyperstimulation syndrome (OHSS) subjected to gonadotropin releasing hormone (GnRH) antagonist protocol followed by trigger with concomitant GnRH agonist (GnRHa) and low-dose human chorionic gonadotropin (HCG) administration (dual trigger), GnRHa trigger with single luteal low-dose HCG or GnRHa trigger with multiple luteal low-doses HCG
Detailed Description
The GnRH antagonist fixed protocol will be used for controlled ovarian hyperstimulation (COH). Transvaginal sonography (TVS) scan will be performed regularly for monitoring of the follicular growth (folliculometry). When there will be at least 3 leading follicles > 18 mm in diameter, women will be randomized into 3 groups; group A (dual trigger group), group B (single low-dose HCG group) and group C (multiple low-doses HCG group). In group A, final oocyte maturation will be triggered by dual administration of 0.2 mg of GnRHa preparation (Triptorelin) SC and 1500 IU of HCG preparation IM. In group B, final oocyte maturation will be triggered by administration of 0.2 mg Triptorelin SC then a single IM bolus of 1500 IU HCG will by administered 35-37 hours after GnRHa trigger (1 hour after oocyte retrieval). In group C, final oocyte maturation will be triggered by administration of 0.2 mg Triptorelin SC then 3 IM boluses of 500 IU HCG will be administered day 1, day 4 and day 7 after oocyte retrieval. In all women, oocyte retrieval will be performed 34-36 hours after trigger and endometrial preparation for embryo transfer (ET) will be started on the day of oocyte retrieval by giving 400 mg vaginal natural progesterone supplement once daily plus 4 mg oral estradiol valerate once daily.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
GnRHa trigger, Luteal phase support, OHSS
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
225 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dual trigger group
Arm Type
Active Comparator
Arm Description
Trigger with concomitant GnRHa and HCG (single low-dose) administration
Arm Title
Single low-dose HCG group
Arm Type
Active Comparator
Arm Description
Trigger with GnRHa then HCG (single low-dose) administration in luteal phase
Arm Title
Multiple low-doses HCG group
Arm Type
Active Comparator
Arm Description
Trigger with GnRHa then HCG (multiple low-doses) administration in luteal phase
Intervention Type
Drug
Intervention Name(s)
GnRHa and HCG
Other Intervention Name(s)
Decapeptyl and Pregnyl
Intervention Description
Final oocyte maturation will be triggered by dual administration of 0.2 mg of GnRHa preparation (Triptorelin) SC and 1500 IU of HCG preparation IM
Intervention Type
Drug
Intervention Name(s)
GnRHa then HCG (single low-dose)
Other Intervention Name(s)
Decapeptyl then Pregnyl
Intervention Description
Final oocyte maturation will be triggered by administration of 0.2 mg Triptorelin SC then a single IM bolus of 1500 IU HCG will be administered 35-37 hours after GnRHa trigger (1 hour after oocyte retrieval)
Intervention Type
Drug
Intervention Name(s)
GnRHa then HCG (multiple low-doses)
Other Intervention Name(s)
Decapeptyl then Pregnyl
Intervention Description
Final oocyte maturation will be triggered by administration of 0.2 mg Triptorelin SC then 3 IM boluses of 500 IU HCG will be administered day 1, day 4 and day 7 after oocyte retrieval
Primary Outcome Measure Information:
Title
Clinical pregnancy rate
Description
Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 4-6 weeks after the ET) divided by the number of ET procedures
Time Frame
6 weeks after embryo transfer
Secondary Outcome Measure Information:
Title
Oocyte maturation rate
Description
Number of mature oocytes divided by the number of retrieved oocytes
Time Frame
On day of oocyte retrieval
Title
Incidence of early OHSS
Description
Incidence of OHSS within 9 days of final triggering of oocyte maturation
Time Frame
Within 9 days of final triggering of oocyte maturation
Title
Implantation rate
Description
Number of gestational sacs on TVS scan at 4-6 weeks after ET divided by the number of transferred embryos
Time Frame
6 weeks after embryo transfer
Title
Miscarriage rate
Description
Number of first trimester miscarriages (before 12 weeks gestational age) divided by the number of clinical pregnancies
Time Frame
12 weeks gestational age
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women subjected to ICSI through controlled ovarian hyperstimulation (COH) with pituitary downregulation by GnRH antagonist.
Presence of risk for development of OHSS: 1) previous moderate or severe OHSS; 2) PCOS or polycystic ovary on ultrasound scan; 3) antral follicle count (AFC) > 14 in both ovaries; 4) basal serum AMH level > 3.36 ng/ml; 5) > 14 follicles with diameter of ≥ 11 mm on the day of triggering of oocyte maturation; 6) E2 level > 3000 pg/ml on the day of triggering of oocyte maturation.
Exclusion Criteria:
Age < 20 years or > 35 years.
BMI < 19 kg/m2 or > 35 kg/m2.
Moderate or severe endometriosis.
Hydrosalpinx.
Uterine abnormalities or myoma.
Previous uterine surgery.
Use of alternative techniques to minimize the risk of OHSS.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed S Abdelhafez, Dr
Phone
+201144523366
Email
msabdelhafez@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed S Abdelhafez, Dr
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Waleed El-refaie, Dr
Organizational Affiliation
Port Said University
Official's Role
Study Director
Facility Information:
Facility Name
Fertility Care Unit (FCU) in Mansoura University Hospital
City
Mansourah
State/Province
Dakahlia
ZIP/Postal Code
35111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed S Abdelhafez, Dr
Phone
+201144523366
Email
msabdelhafez@gmail.com
Facility Name
Private fertility care centers
City
Mansourah
State/Province
Dakahlia
Country
Egypt
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Dual Trigger Versus GnRHa Trigger Combined With Luteal HCG Administration
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