Evaluate the Effectiveness of Progestin-Primed Versus GnRH Antagonist Protocols in Vietnamese Women Undergoing In-vitro Fertilization
1 other identifier
interventional
200
1 country
1
Brief Summary
This study aims to evaluate the efficacy of the progestin-primed ovary stimulation (PPOS) protocol compared to the standard GnRH antagonist (GnRH\_ant) protocol across successive stages in a controlled ovarian stimulation (COS) and ICSI procedure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2023
Typical duration for not_applicable
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
Study Start
First participant enrolled
February 14, 2023
CompletedFirst Submitted
Initial submission to the registry
December 16, 2023
CompletedFirst Posted
Study publicly available on registry
January 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedJanuary 5, 2024
January 1, 2024
1.9 years
December 16, 2023
January 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The quantity of day 3rd and day 5th embryos and MII oocytes
11 months after initiation of treatment in either arm
Study Arms (2)
PPOS protocol
ACTIVE COMPARATOROvarian stimulation protocol used progestin as premature LH surge inhibitor
GnRH-ant protocol
ACTIVE COMPARATOROvarian stimulation protocol used GnRH antagonist as premature LH surge inhibitor
Interventions
Ovarian Stimulation Process: * Stimulate ovaries with FSH \& hMG (150-375 IU) starting day 2-3 of menstruation. * Monitor response with ultrasound \& hormones (E2, LH, P4). * GnRH-ant arm: Prevent LH surge with Cetrorelix (0.25mg) starting day 5. * PPOS arm: Suppress LH with Dydrogesterone (10mg x 3/day) from day 1. * Trigger ovulation when ≥2 follicles \>17mm (Triptorelin, hCG, or rhCG). * Oocyte retrieval 36-38 hours later (\>10mm follicles aspirated). Embryo Culture \& Monitoring: * Fertilize with ICSI. * Culture \& evaluate embryos (43-45 hours, day 3/5). * Freeze all embryos.
Eligibility Criteria
You may qualify if:
- Women meeting the sample selection criteria are as follows:
- Women age 20 to 45 years old.
- Infertility due to male factors, fallopian tube factors, or unknown causes.
- Undergoing IVF in one COS cycle and intended to apply either GnRH antagonist protocol or PPOS protocol
- Voluntary participation in research.
You may not qualify if:
- Any contraindications to ovarian stimulation and IVF/ICSI treatment
- Hyperprolactinemia or other endocrine diseases.
- Those who took hormone drugs within the past 3 months
- Suffering from systemic diseases such as kidney failure, lupus erythematosus, depression, etc.
- Abnormal structure of the uterine cavity.
- Patients with endometriosis or cancer
- Random-start cycles.
- Oocyte donation cycles
- Perform embryo biopsy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Univesity of Medicine and Pharmacy at Ho Chi Minh City
Ho Chi Minh City, 700000, Vietnam
Study Officials
- PRINCIPAL INVESTIGATOR
Thach Than Trong
Hanoi Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 16, 2023
First Posted
January 5, 2024
Study Start
February 14, 2023
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
January 5, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share