Evaluate the Effectiveness of Progestin-Primed Versus GnRH Antagonist Protocols in Vietnamese Women Undergoing In-vitro Fertilization: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- The quantity of day 3rd and day 5th embryos and MII oocytes
Study Overview
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.
Detailed Description
Materials and Method
This was an open-label, randomized controlled trial conducted at the Assisted Reproduction Center of Tam Anh General Hospital. The study aimed to estimate the efficacy of the intervention (PPOS protocol) compared to a control group receiving a gonadotropin-releasing hormone (GnRH) antagonist protocol.
Sample size estimation
The sample size estimation procedure is detailed in the study protocol. In brief, the investigators conducted a simulation that implied the method by Cundill and Alexander (2015) with parameters derived from the clinical profile of 804 patients who underwent ovarian stimulation by two protocols at Tam Anh Hospital from January to October 2022. The procedure aimed to optimize non-inferiority testing on the difference in the quantity of retrieved oocytes between two groups, estimated by a Negative Binomial distribution. The simulation result indicated that a total sample size of 200 patients (n=100 for each treatment arm) would be required to achieve a statistical power of 0.8.
Recruitment of study participants
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
The quantity of day 3rd and day 5th embryos and MII oocytes
Time Frame: 11 months after initiation of treatment in either arm
Secondary Outcomes
No secondary outcomes reported
Investigators
Thach Than Trong
Principal Investigator
Hanoi Medical University