Comparison of the Euploid Rate of Blastocyst Between PPOS and GnRH Antagonist Protocol in Women With PCOS 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 (progestin-primed ovarian stimulation) and GnRH (gonadotrophin releasing hormone) antagonist protocols in patients with PCOS (polycystic ovary syndrome) undergoing PGT-A (preimplantation genetic testing for aneuploidy). Infertile women with PCOS 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 MPA (medroxyprogesterone acetate)10mg qd 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 PPOS (Progestin-primed Ovarian Stimulation) Protocol and the Gonadotropin-releasing Hormone (GnRH) Antagonist Protocol in Women With PCOS (Polycystic Ovary Syndrome) Undergoing PGT-A (Preimplantation Genetic Testing for Aneuploidy)

Conditions
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Preimplantation Genetic Testing, Progestin-primed Ovarian Stimulation, Polycystic Ovarian Syndrome, GnRH Antagonist

Intervention / Treatment
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* Drug: GnRH antagonist
* Drug: MPA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women age between 20 and 37 years. Women diagnosed with PCOS according to the modified Rotterdam criteria: oligomenorrhea or amenorrhea, together with the presence of ≥12 antral follicles (≤9 mm) and/or ovarian volume >10 mL on transvaginal ultrasonographic scanning, and/or clinical/ biochemical hyperandrogenism. Other causes of hyperandrogenism and ovulation dysfunction-including tumours, congenital adrenal hyperplasia, hyperprolactinaemia and thyroid dysfunction-were excluded Exclusion Criteria: Presence of a functional ovarian cyst with E2>100 pg/mL Endometriosis grade 3 or higher Repeated implantation failure (>=4 embryos replaced or >=2 blastocysts replaced without success) Women with a uterine cavity abnormality, such as a uterine congenital malformation (uterus uni-cornate, bicornate, or duplex); untreated uterine septum, adenomyosis, submucous myoma, or endo-metrial polyp(s) Women who are indicated and planned to undergo PGT-SR (Preimplantation genetic testing for structural rearrangement) or PGT-M (Preimplantation genetic testing for monogenic disorder), for example, parental abnormal karyo-type or diagnosed with monogenic disease; Recipient of oocyte donation Presence of hydrosalpinx which is not surgically treated

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 37 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 ovarian stimulation till the day of the ovulation trigger<br>* Other names: Cetrorelix;|
| Experimental: PPOS group<br>Women will receive oral MPA 10mg qd from Day 3 till the day of ovulation trigger. | Drug: MPA<br>* oral MPA 10mg qd from Day 3 of ovarian stimulation till the day of ovulation trigger.<br>|

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 |
| --- | --- | --- |
| live birth rate | deliveries ≥22 weeks gestation with heartbeat and breath of the first frozen embryo transfer | 1 year after embryo transfer | 
| cumulative live birth rate | cumulative live birth within 6 months of randomization | 1 year after embryo transfer | 
| ongoing pregnancy | a viable pregnancy beyond 12 weeks' gestation of the first frozen embryo transfer | 12 weeks' gestation | 
| number of oocytes retrieved | number of oocytes retrieved | 1 day after oocyte retrieval | 
| OHSS（ovarian hyperstimulation syndrome） | Moderate or severe ovarian hyperstimulation syndrome.Ovarian hyperstimulation syndrome (OHSS) is diagnosed and classified according to the Royal College of Obstetricians and Gynaecologists guideline. Green-top guideline No.5. Ovarian hyperstimulation syndrome. https://www.rcog.org.uk/en/guidelines-research-services/guidelines/gtg5/ (accessed 26 Feb 2016). | 1 month after ovarian stimulation | 
| birthweight of newborns | birthweight of newborns | 1 year after embryo transfer |