Actively Recruiting
Dydrogesterone Primed Ovarian Stimulation Versus Fixed GnRH Antagonist Protocol for Oocyte Accumulation in Low Ovarian Reserve Patients: A Randomized Controlled Trial
Led by Tam Anh TP. Ho Chi Minh General Hospital · Updated on 2025-12-10
730
Participants Needed
2
Research Sites
30 weeks
Total Duration
On this page
Sponsors
T
Tam Anh TP. Ho Chi Minh General Hospital
Lead Sponsor
A
Abbott
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate ovarian stimulation protocols for women with diminished ovarian reserve (DOR), a condition where fewer eggs are available, resulting in fewer embryos formed during IVF treatment. The trial compares two methods: the Progestin-primed ovarian stimulation (PPOS) protocol using Dydrogesterone (DPOS) and the traditional GnRH antagonist protocol. The study seeks to provide stronger evidence on effectiveness and safety, as current data on PPOS, especially with Dydrogesterone, is limited. Participants will be randomly assigned to one of two groups. In the DPOS group, women receive oral Dydrogesterone 30mg daily along with daily injections of Human Menopausal Gonadotrophin (hMG) starting from day 2 to 4 of their menstrual cycle until final egg maturation. The GnRH antagonist group receives daily hMG injections from day 2 to 4 and daily GnRH antagonist injections starting on day 5 until egg maturation. After egg retrieval, mature eggs are frozen and later thawed for fertilization by ICSI. Embryos are cultured to blastocyst stage and frozen for transfer in a later cycle, with hormonal therapy preparing the uterus. Participants will undergo monitoring including hormone level checks during stimulation and ultrasound to track egg development. Pregnancy tests and ultrasounds confirm ongoing pregnancy after embryo transfer. Researchers will measure ongoing pregnancy rates at 11 to 12 weeks of gestation and evaluate various hormone levels, egg and embryo quality, and treatment safety. The total study duration includes ovarian stimulation cycles, embryo freezing and transfer, and follow-up through early pregnancy confirmation.
CONDITIONS
Brief Title
DPOS Versus GnRH Antagonist Protocol for Oocyte Accumulation in Low Ovarian Reserve Patients: An RCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged between 18 and 37 years
- Antral follicle count (AFC) of 5 or less and/or anti-Müllerian hormone (AMH) level of 1.2 ng/ml or less
- Agree to use freeze-all strategy and single frozen blastocyst embryo transfer
You will not qualify if you...
- Oocyte recipients
- Indication for preimplantation genetic testing
- Known allergies to study medications such as progesterone products or GnRH antagonist
- Basal follicle stimulating hormone (FSH) level above 15 mIU/mL
- Contraindications to assisted reproductive technology treatment (e.g., critical or acute diseases)
- Use of retrieved sperm
- Repeated implantation failure (three or more failed embryo transfers with good-quality embryos)
- Inability to comply with study procedures
- History of thyroid cancer on hormone replacement therapy or current thyroid disease at eligibility assessment
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 weeks per ovarian stimulation cycle
Participants will undergo ovarian stimulation using either a Dydrogesterone primed protocol or a GnRH antagonist protocol to stimulate egg development. This involves daily medication injections and oral treatments from menstrual cycle day 2 to the day of final oocyte maturation, followed by egg retrieval and freezing.
Daily visits or medication administration during stimulation; 1 oocyte retrieval visit per cycle
Duration - Approximately 1 to 2 months including fertilization, embryo culture, freezing, endometrial preparation, and embryo transfer
After reaching the target number of frozen eggs, participants will have their eggs thawed and fertilized using ICSI (intracytoplasmic sperm injection). The resulting embryos will be cultured to blastocyst stage, frozen, and then transferred in a later cycle following endometrial preparation.
Multiple visits including egg thawing, embryo transfer, and endometrial monitoring
Duration - Up to 12 weeks of gestation
Participants will undergo pregnancy testing 10 to 11 days after embryo transfer and an ultrasound at about 7 weeks of gestation to confirm fetal viability. If pregnant, hormone support continues until at least 12 weeks of gestation.
2 visits: 1 blood pregnancy test and 1 pregnancy ultrasound
Trial Site Locations
Total: 2 locations
1
IVFTA
Hanoi, Hanoi, Vietnam, 100000
Actively Recruiting
2
Ivfta Hcmc
Ho Chi Minh City, Ho Chi Minh, Vietnam, 70000
Actively Recruiting
Research Team
N
Nhu H Giang, MD., MCE
L
Loc M T Nguyen, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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