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

Primary Purpose

Preimplantation Genetic Testing, Progestin-primed Ovarian Stimulation, Polycystic Ovarian Syndrome

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
GnRH antagonist
MPA
Sponsored by
ShangHai Ji Ai Genetics & IVF Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preimplantation Genetic Testing

Eligibility Criteria

20 Years - 37 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Antagonist group

    PPOS group

    Arm Description

    Women will receive antagonist (Cetrotide 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger.

    Women will receive oral MPA 10mg qd from Day 3 till the day of ovulation trigger.

    Outcomes

    Primary Outcome Measures

    euploidy rate
    euploidy rate of blastocysts

    Secondary Outcome Measures

    live birth rate
    deliveries ≥22 weeks gestation with heartbeat and breath of the first frozen embryo transfer
    cumulative live birth rate
    cumulative live birth within 6 months of randomization
    ongoing pregnancy
    a viable pregnancy beyond 12 weeks' gestation of the first frozen embryo transfer
    number of oocytes retrieved
    number of oocytes retrieved
    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).
    birthweight of newborns
    birthweight of newborns

    Full Information

    First Posted
    March 28, 2022
    Last Updated
    April 21, 2023
    Sponsor
    ShangHai Ji Ai Genetics & IVF Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05326087
    Brief Title
    Comparison of the Euploid Rate of Blastocyst Between PPOS and GnRH Antagonist Protocol in Women With PCOS Undergoing PGT-A
    Official Title
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2023 (Anticipated)
    Primary Completion Date
    December 1, 2025 (Anticipated)
    Study Completion Date
    December 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    ShangHai Ji Ai Genetics & IVF Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Preimplantation Genetic Testing, Progestin-primed Ovarian Stimulation, Polycystic Ovarian Syndrome, GnRH Antagonist

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    204 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Antagonist group
    Arm Type
    Active Comparator
    Arm Description
    Women will receive antagonist (Cetrotide 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger.
    Arm Title
    PPOS group
    Arm Type
    Experimental
    Arm Description
    Women will receive oral MPA 10mg qd from Day 3 till the day of ovulation trigger.
    Intervention Type
    Drug
    Intervention Name(s)
    GnRH antagonist
    Other Intervention Name(s)
    Cetrorelix
    Intervention Description
    GnRH antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger
    Intervention Type
    Drug
    Intervention Name(s)
    MPA
    Intervention Description
    oral MPA 10mg qd from Day 3 of ovarian stimulation till the day of ovulation trigger.
    Primary Outcome Measure Information:
    Title
    euploidy rate
    Description
    euploidy rate of blastocysts
    Time Frame
    1 month after oocyte retrieval
    Secondary Outcome Measure Information:
    Title
    live birth rate
    Description
    deliveries ≥22 weeks gestation with heartbeat and breath of the first frozen embryo transfer
    Time Frame
    1 year after embryo transfer
    Title
    cumulative live birth rate
    Description
    cumulative live birth within 6 months of randomization
    Time Frame
    1 year after embryo transfer
    Title
    ongoing pregnancy
    Description
    a viable pregnancy beyond 12 weeks' gestation of the first frozen embryo transfer
    Time Frame
    12 weeks' gestation
    Title
    number of oocytes retrieved
    Description
    number of oocytes retrieved
    Time Frame
    1 day after oocyte retrieval
    Title
    OHSS（ovarian hyperstimulation syndrome）
    Description
    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).
    Time Frame
    1 month after ovarian stimulation
    Title
    birthweight of newborns
    Description
    birthweight of newborns
    Time Frame
    1 year after embryo transfer

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    37 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    HE LI, MD
    Phone
    +8613817223099
    Email
    lihe198900@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    XIAOXI SUN, PHD
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    XIAOXI SUN, PHD
    Organizational Affiliation
    Shanghai JiAi Genetics & IVF Institute, China
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Individual participant data that underlie the results after deidentification (text, tables, figures, and appendices) and study protocol will be shared.
    IPD Sharing Time Frame
    Data will be available when beginning 3 months and ending 5 years following article publication.
    IPD Sharing Access Criteria
    To achieve aims in the approved proposal, researchers who provide a methodologically sound proposal will be shared with. Proposals should be sent to lihe198900@163.com.
    Citations:
    PubMed Identifier
    30927417
    Citation
    Begueria R, Garcia D, Vassena R, Rodriguez A. Medroxyprogesterone acetate versus ganirelix in oocyte donation: a randomized controlled trial. Hum Reprod. 2019 May 1;34(5):872-880. doi: 10.1093/humrep/dez034.
    Results Reference
    background
    PubMed Identifier
    25432917
    Citation
    Lee E, Illingworth P, Wilton L, Chambers GM. The clinical effectiveness of preimplantation genetic diagnosis for aneuploidy in all 24 chromosomes (PGD-A): systematic review. Hum Reprod. 2015 Feb;30(2):473-83. doi: 10.1093/humrep/deu303. Epub 2014 Nov 28.
    Results Reference
    background
    PubMed Identifier
    28062551
    Citation
    Massin N. New stimulation regimens: endogenous and exogenous progesterone use to block the LH surge during ovarian stimulation for IVF. Hum Reprod Update. 2017 Mar 1;23(2):211-220. doi: 10.1093/humupd/dmw047.
    Results Reference
    background
    PubMed Identifier
    25956370
    Citation
    Kuang Y, Chen Q, Fu Y, Wang Y, Hong Q, Lyu Q, Ai A, Shoham Z. Medroxyprogesterone acetate is an effective oral alternative for preventing premature luteinizing hormone surges in women undergoing controlled ovarian hyperstimulation for in vitro fertilization. Fertil Steril. 2015 Jul;104(1):62-70.e3. doi: 10.1016/j.fertnstert.2015.03.022. Epub 2015 May 5.
    Results Reference
    background
    PubMed Identifier
    16249284
    Citation
    Ehrmann DA, Liljenquist DR, Kasza K, Azziz R, Legro RS, Ghazzi MN; PCOS/Troglitazone Study Group. Prevalence and predictors of the metabolic syndrome in women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2006 Jan;91(1):48-53. doi: 10.1210/jc.2005-1329. Epub 2005 Oct 25.
    Results Reference
    background

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

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