Status:
COMPLETED
GnRHa Trigger in Asian Oocyte Donors- a Dose Finding Study
Lead Sponsor:
Vietnam National University
Collaborating Sponsors:
Merck Sharp & Dohme LLC
The Fertility Clinic, Skive Regional Hospital, Denmark
Conditions:
Normal Oocyte Donors
Eligibility:
FEMALE
18-35 years
Phase:
NA
Brief Summary
The aim of this randomized single center study is to explore the most optimal dose of GnRHa used for triggering of final oocyte maturation in IVF. The study group will consist of oocyte donors who hav...
Detailed Description
Methods A randomized controlled single center study. All oocyte donors, fulfilling the inclusion criteria, will be eligible for inclusion after randomization. Stimulation, monitoring, oocyte pick-up...
Eligibility Criteria
Inclusion
- Oocyte donors who meet the following criteria:
- Age 18 - 35
- BMI \< 28kg/m2
- Normal ovarian reserve, defined by AMH \> 1.25 ng/ml or AFC ≥ 6 measured within two months prior to stimulation start
- Receiving GnRH-antagonist protocol for ovarian stimulation,
- Agreement to participate in the study, and to disclose any medical events to the investigator. The subject must be willing and able to comply with the protocol requirements for the duration of the study.
- Have given written informed consent with the understanding that the subject may withdraw consent at any time without prejudice to future medical care.
Exclusion
- Previous poor response (≤ 3 oocytes) after high dose FSH stimulation
- Chronical medical conditions like Diabetes, Crohns disease, Thyroid disease, Hepatitis B and Sexually Transmitted Diseases Simultaneous participation in an interventional clinical trial.
- Concommitant use of either LH or hMG/uFSH preparations in study cycle
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT02208986
Start Date
August 1 2014
End Date
March 1 2015
Last Update
February 6 2017
Active Locations (1)
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1
My Duc Hospital, IVFMD
Ho Chi Minh City, Ho Chi Minh, Vietnam