DRUG
Dydrogesterone 10 mg
Dydrogesterone 10mg orally 2 times daily, starting on the day of gonadotropin injection to the oocyte maturation trigger night.
Status
Active, not recruiting
Phase
Not applicable
Enrollment
626
Locations
1
Results
Not posted
Publications
12
Study summary
This non-inferiority randomized controlled trial will be conducted at My Duc Hospital, Ho Chi Minh City, Vietnam. This study compares the effectiveness of Progestin-Primed Ovarian stimulation versus GnRH protocol for ovarian stimulation in IVF treatment. Participants will be randomly assigned in a 1:1 ratio to receive Progestins or GnRH antagonists.
Study Procedures Participants will be randomized into two arms: * PPOS group: Recombinant FSH 150-300 IU/day will start from day 2 to day 4 of menstruation. The initial FSH dose will be chosen based on age, anti-Müllerian hormone (AMH) level, antral follicle count (AFC), and body mass index (BMI). The FSH dosage will be fixed during ovarian stimulation. Dydrogesterone (Duphaston, Abbott, USA) 20mg/day will start on the day of gonadotropin injection to the oocyte maturation trigger night. * GnRH antagonist group: Recombinant FSH 150-300 IU/day will be given from day 2 to day 4 of menstruation. The initial FSH dose will be chosen based on age, anti-Müllerian hormone (AMH) level, antral follicle count (AFC), and body mass index (BMI). The FSH dosage will be fixed during ovarian stimulation. Cetrorelix (Cetrotide, Merck, Germany) 0.25mg/day will be given from day 5 of stimulation by the oocyte maturation trigger day. Follicular monitoring will start on the fifth or sixth day of ovarian stimulation and was performed every 3-5 days thereafter using transvaginal ultrasound to record the number of developing follicles. Measuring LH, estradiol, and progesterone serum levels will be performed on the fifth or sixth day of ovarian stimulation and oocyte maturation day (before the trigger injection). The FSH dosage will be fixed during ovarian stimulation. When more than two dominant follicles reach a diameter of at least 17mm, \>= 50% diameter of remaining follicles cohort \>=12 mm, the final stage of oocyte maturation will trigger using human chorionic gonadotropin (hCG; IVF-C 10.000 IU, LG Chem, Ltd., Korea or Ovitrelle Pen 250µg, Merck Serono S.p.A., Italy). In individuals who are at high risk for OHSS, GnRH agonist trigger 0.2mg (Diphereline 0.2mg, Ipsen Pharma, France) will given subcutaneously. Transvaginal ultrasound-guided oocyte retrieval will be performed 34-36 hours after trigger, with the retrieval of all follicles exceeding 10mm in diameter. Oocyte fertilization will be carried out in vitro using ICSI. On the third day after fertilization, embryos will be evaluated for the degree of embryonic fragmentation, regularity, and number of blastomeres in accordance with the Istanbul consensus (Alpha Scientists in Reproductive Medicine and ESHRE Special Interest Group of Embryology, 2011). Day 3 embryos will be cryopreserved or cultured until the blastocyst stage based on physician recommendation or patient references; viable blastocysts will then be cryopreserved on day 5 or day 6. Endometrial preparation for frozen embryo transfer (FET) will be given using an exogenous steroid regimen from day 2 to day 4 of the menstrual cycle. Oral estradiol valerate (Progynova, Bayer Schering Pharma, Germany) 8mg/day will be given for 10-12 days. When endometrial thickness reaches ≥ 7mm, along with a triple-line pattern, micronized progesterone 800mg will be administered. FET will be performed three to five days after progesterone administration. There will be no more than 2 embryo(s) transfers each FET cycle. After FET, estradiol and progesterone supplementation will be continued for all participants until the day of taking the pregnancy test. Participants with a positive pregnancy test continued to receive oral estradiol valerate 8mg/day and micronized progesterone 800mg/day until the fetal heart appeared, and then only micronized progesterone 800mg will be used until 12 weeks of gestation. All participants will be followed up per local protocol until outcomes are achieved.
Interventions
DRUG
Dydrogesterone 10mg orally 2 times daily, starting on the day of gonadotropin injection to the oocyte maturation trigger night.
DRUG
Cetrorelix 0.25mg is injected subcutaneously once a day. It is given from day 5 or day 6 of stimulation by the oocyte maturation trigger day.
Timeline
First posted
Apr 22, 2024
Study start
Apr 24, 2024
Primary completion
Jun 30, 2026
Study completion
Sep 30, 2026
Results posted
Not reported
Registry updated
Mar 20, 2026
Outcomes
Ongoing pregnancy
Time frame · At 10 weeks after embryo(s) placement
defined as pregnancy with a detectable heart rate at 12 weeks gestation or beyond
The incidence of premature LH surge
Time frame · On the day having indication of oocyte maturation
LH level of ≥ 10 mIU/mL occurring before the criteria of oocyte maturation administration is met
The incidence of premature progesterone elevation
Time frame · On the day having indication of oocyte maturation
A progesterone level of ≥1.0 ng/mL occurring before the criteria of oocyte maturation administration is met
Number of oocytes retrieved
Time frame · On the oocyte(s) retrieval day
The number of oocyte retrieved
Number of mature oocytes
Time frame · On the oocyte(s) retrieval day
The number of MII oocytes
Number of day 3 embryos
Time frame · At 62-66 hours after ICSI
The number of day 3 embryos
Number of day 5 embryos
Time frame · At 112-116 hours after ICSI
The number of day 5 embryos
Number of good quality day 3 embryos
Time frame · At 62-66 hours after ICSI
Number of grade 1 and grade 2 day 3 embryos (acccording to Alpha Scientists in Reproductive Medicine and ESHRE Special Interest Group of Embryology, 2011)
Number of good quality day 5 embryos
Time frame · At 112-116 hours after ICSI
Number of grade 1 and grade 2 day 5 blastocysts (acccording to Alpha Scientists in Reproductive Medicine and ESHRE Special Interest Group of Embryology, 2011)
Number of frozen embryos
Time frame · at 112-116 hours after ICSI
the number of frozen embryos/blastocysts
Incidence of Ovarian hyperstimulation syndrome
Time frame · At 2 weeks after trigger
Ovarian hyperstimulation syndrome (OHSS) is a potentially lethal iatrogenic complication of the early luteal phase or/and early pregnancy after ovulation induction (OI) or ovarian stimulation (OS). OHSS was evaluated if symptoms were reported by the patient. OHSS was classified using the flow diagram developed by (Humaidan et al., 2016)
Eligibility
Inclusion Criteria: * Woman aged 18-40 * BMI ≤ 25kg/m2 * AMH \> 1.2ng/mL or AFC \>5 * Having indication for IVF treatment * Agree to have frozen embryo(s) transfer * Not participating in any other clinical trials * Provision of written informed consent to participate Exclusion Criteria: * Undergoing IVF cycle with other protocols: Down-regulation, mild stimulation, Random start * Oocyte donation cycles * Undergoing vitrified oocyte accumulation * Oocyte cryopreservation * Cycle with PGT (Preimplatation genetic testing) * Women with PCOS * Women allergy to dydrogesterone, rFSH, GnRH antagonist
Study locations
Vietnam. Showing up to 24 locations stored in the fast local snapshot.
My Duc Hospital
Ho Chi Minh City, Ho Chi Minh City, Vietnam
Publications
Related trials
Ahmed Saad · Poor Ovarian Reserve · Infertility (IVF Patients)
Phase 1 / Phase 2
Not yet recruiting
100
2026-07
Centro A.M.B.R.A. (Associazione Medici e Biologi per la Riproduzione Assistita) · Infertility, Female · Ovulation Induction
Early Phase 1
Not yet recruiting
189
2026-07
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany · Infertility
Phase 3
Recruiting
266
2026-07
ART Fertility Clinics LLC · Ovarian Stimulation
Not applicable
Recruiting
150
2026-06
Bedaya Hospital · Infertility
Phase 2
Recruiting
120
2026-05
Beni-Suef University · IVF · PCO
Phase 2 / Phase 3
Completed
200
2026-04
Assistance Publique - Hôpitaux de Paris · Infertility
Phase 4
Completed
129
2026-04
Institut Cancerologie de l'Ouest · Breast Cancer
Phase 2
Active, not recruiting
102
2026-03
Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.