Dual Trigger Versus GnRHa Trigger Combined With Luteal HCG Administration
NCT ID: NCT02330770
Last Updated: 2023-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
225 participants
INTERVENTIONAL
2016-06-06
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Dual trigger group
Trigger with concomitant GnRHa and HCG (single low-dose) administration
GnRHa and HCG
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
Single low-dose HCG group
Trigger with GnRHa then HCG (single low-dose) administration in luteal phase
GnRHa then HCG (single low-dose)
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)
Multiple low-doses HCG group
Trigger with GnRHa then HCG (multiple low-doses) administration in luteal phase
GnRHa then HCG (multiple low-doses)
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
Interventions
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GnRHa and HCG
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
GnRHa then HCG (single low-dose)
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)
GnRHa then HCG (multiple low-doses)
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
35 Years
FEMALE
No
Sponsors
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Mansoura University
OTHER
Responsible Party
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Mohamed Sayed Abdelhafez
Dr
Principal Investigators
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Mohamed S Abdelhafez, Dr
Role: PRINCIPAL_INVESTIGATOR
Mansoura University
Waleed El-refaie, Dr
Role: STUDY_DIRECTOR
Port Said University
Locations
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Fertility Care Unit (FCU) in Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, Egypt
Private fertility care centers
Al Mansurah, Dakahlia Governorate, Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MSA5
Identifier Type: -
Identifier Source: org_study_id
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