Comparison of the Euploid Rate of Blastocyst Between PPOS and GnRH Antagonist Protocol in Patients Undergoing PGT-A

Study Overview
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Brief Summary
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This randomized trial aims to compare the euploid rate of blastocysts between PPOS and GnRH antagonist protocols in patients undergoing PGT-A. Infertile women who have medical indication for PGT-A will be recruited for study after explanation and counseling if they fulfill the inclusion criteria and do not have the exclusion criteria. Eligible women will be randomised into one of the two groups: Antagonist group: Women will receive antagonist once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger. PPOS group: Women will receive oral Duphaston 10mg bd from Day 3 till the day of ovulation trigger. The primary outcome is the euploidy rate of blastocysts.

Official Title
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A Randomized Control Trial to Compare the Euploid Rate of Blastocyst Between the Progestin-primed Ovarian Stimulation Protocol and the GnRH Antagonist Protocol in Patients Undergoing PGT-A

Conditions
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Preimplantation Genetic Testing, Progestin-primed Ovarian Stimulation, Euploid Rate, GnRH Antagonist

Intervention / Treatment
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* Drug: GnRH antagonist
* Drug: oral Duphaston


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of women <43 years at the time of ovarian stimulation for IVF Antral follicle count (AFC) >=5 on day 2-5 of the period PGT-A indicated for advanced maternal age (>=38 years), recurrent miscarriage (>=2 consecutive miscarriage) and repeated implantation failure (>=4 embryos replaced or >=2 blastocysts replaced without success), recurrent foetal aneuploidy Exclusion Criteria: Presence of a functional ovarian cyst with E2>100 pg/mL Recipient of oocyte donation Presence of hydrosalpinx or endometrial polyp which is not surgically treated

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 43 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Antagonist group<br>Women will receive antagonist (Cetrotide 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger. | Drug: GnRH antagonist<br>* GnRH antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of COH till the day of the ovulation trigger<br>* Other names: Cetrorelix;|
| Experimental: PPOS group<br>Women will receive oral Duphaston 10mg bd from Day 3 till the day of ovulation trigger. | Drug: oral Duphaston<br>* oral Duphaston 10mg bd from Day 3 of COH till the day of ovulation trigger.<br>* Other names: Duphaston;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| euploidy rate | euploidy rate of blastocysts | 1 month after oocyte retrieval | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of mature oocytes | number of MII oocytes | 1 day after oocyte retrieval | 
| number and grading of blastocysts | number and grading of blastocysts suitable for biopsy and freezing | 1 week after oocyte retrieval | 
| positive serum hCG | serum β-hCG ≥10 mIU/mL of the first FET | 2 weeks after FET | 
| clinical pregnancy | presence of intrauterine gestational sac by trans-vaginal ultrasound at 6 gestational weeks of the first FET | 6 weeks' gestation | 
| implantation rate | the number of gestational sacs per blastocyst transferred of the first FET | 6 weeks' gestation | 
| biochemical pregnancy | positive serum hCG not followed by clinical pregnancy of the first FET | 6 weeks' gestation | 
| ongoing pregnancy | a viable pregnancy beyond 12 weeks' gestation of the first FET | 12 weeks' gestation | 
| live birth rate | deliveries ≥22 weeks gestation with heartbeat and breath of the first FET | 1 year after FET | 
| multiple pregnancy | more than one intrauterine sacs on scanning | multiple pregnancy beyond gestation 12 weeks | 
| ectopic pregnancy | pregnancy outside the uterine cavity | ectopic pregnancy during 12 weeks' gestation | 
| birthweight of newborns | the birth weight of newborns | 1 year after FET | 
| serum baseline FSH | baseline FSH of period day 2-3 | day 2-3 of period | 
| progesterone level on the trigger day | progesterone level on the trigger day | 2 days before oocyte retrieval | 
| estradiol level on the trigger day | estradiol level on the trigger day | 2 days before oocyte retrieval | 
| miscarriage | clinically recognised pregnancy loss before 22 weeks of pregnancy. | 22 weeks of pregnancy |