Double Trigger in Patients With Low Number of Oocytes Retrieved Per Number of Preovulatory Follicles
1 other identifier
interventional
56
1 country
1
Brief Summary
The aim of this randomized controlled trial is to determine whether co-administration of GnRH agonist and hCG for final oocyte maturation ( 40 and 34 h prior to oocyte retrieval , respectively) can increase the oocytes yield in patients with history of poor oocytes yield, despite normal response to COH, due to low (\<50%) number of oocytes retrieved per number of follicles \> 14 mm in diameter on day of hCG administration
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2020
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2020
CompletedFirst Posted
Study publicly available on registry
May 29, 2020
CompletedStudy Start
First participant enrolled
May 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 2, 2021
CompletedMay 29, 2020
May 1, 2020
7 months
May 25, 2020
May 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of oocytes retrieved
First day after oocyte retrieval
Secondary Outcomes (1)
clinical pregnancy rate
First 5 weeks after oocyte retrieval
Study Arms (2)
Double trigger
EXPERIMENTALGnRH-agonist and HCG are used to trigger ovulation
HCG
ACTIVE COMPARATORHCG is used to trigger ovulation
Interventions
Final follicular maturation is triggered by the co-administration of GnRH-agonist (Triptorelin acetate, decapeptyl 0.2 mg, Slough, United Kingdom) and 10000 IU of HCG, 40 and 34 h prior to oocyte retrieval, respectively
Final follicular maturation is triggered by a dose of 10000 IU of HCG 36 h prior to oocyte retrieval
Eligibility Criteria
You may qualify if:
- Patients with history of poor oocytes yield in previous IVF attempt, despite normal response to COH, due to low (\<50%) number of oocytes retrieved per number of follicles \> 14 mm in diameter on day of hCG administration
- Patients with 6 to 15 mature follicles on the day oocyte trigger in the current IVF-ET attempt
You may not qualify if:
- Endometriosis
- PCOS
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Riyadh Fertility and Reproductive Health center
Giza, Egypt
Related Publications (1)
Haas J, Zilberberg E, Dar S, Kedem A, Machtinger R, Orvieto R. Co-administration of GnRH-agonist and hCG for final oocyte maturation (double trigger) in patients with low number of oocytes retrieved per number of preovulatory follicles--a preliminary report. J Ovarian Res. 2014 Aug 2;7:77. doi: 10.1186/1757-2215-7-77.
PMID: 25296696BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Usama M Fouda, Prof.
Riyadh Fertility and Reproductive Health center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2020
First Posted
May 29, 2020
Study Start
May 30, 2020
Primary Completion
December 30, 2020
Study Completion
February 2, 2021
Last Updated
May 29, 2020
Record last verified: 2020-05