Euploid Rate of Blastocyst Derived From PPOS VS Antagonist Protocol

Status

Completed

Phase

Not applicable

Enrollment

240 participants (actual)

Sponsor

Shanghai First Maternity and Infant Hospital · Other

Design

Randomized · Single masking

Countries

1 country

China

Start

4 Aug 2021

Primary completion

1 Mar 2023

Completion

20 Feb 2024

First posted

4 Aug 2021

Last update posted

28 Feb 2024

Conditions

IVF

In-vitro fertilization (IVF) involves multiple follicular development, oocyte retrieval and embryo transfer after fertilization. Despite recent advances in ovarian stimulation, the method of assisted fertilization and improved culture conditions, the implantation potential of embryos remains around 30-35% for a long time. Gonadotrophin releasing hormone (GnRH) agonists have been used in IVF to prevent the LH surge and the premature ovulation and are given in the luteal phase of the preceding cycle or in the follicular phase of the treatment cycle i.e. the long GnRH agonist. GnRH antagonists are now commonly used during IVF. In addition to the advantage of its simplicity, the use of antagonist is associated with a substantial reduction in ovarian hyperstimulation syndrome without reducing the chance of achieving live birth when compared with the long agonist protocols. \[1\] Progestin can inhibit the pituitary LH surge during ovarian stimulation and various studies show progestin-primed ovarian stimulation (PPOS) is effective in blocking the LH surge in IVF \[2-5\]. More and more centers in China are using PPOS because this regimen appears simpler and cheaper. Because of its negative effect on the endometrium, fresh transfer of embryos is not possible and elective freezing of all embryos is required. PPOS protocol is indicated in women who freeze all embryos because of various reasons such as undergoing preimplantation genetic testing for aneuploidy or the risk of ovarian hyperstimulation syndrome. One prospective non-randomized study comparing the PPOS vs short GnRH agonist protocol shows similar oocytes retrieved between the two protocols, and the incidence of premature LH surge, clinical pregnancy rate and live birth rates shows no significant difference. \[2\] A recent randomized trial comparing medroxyprogesterone and GnRH antagonist in an oocyte donation program showed a similar number of mature oocytes but reported lower ongoing pregnancy rate and live birth rate of recipients of oocyte donors who had received medroxyprogesterone in IVF \[6\]. However, the oocyte recipients in that trial were not randomized. Therefore, it is not possible to conclude the effect of progestin used in IVF on the pregnancy outcomes. It is possible that the PPOS protocol may have an adverse effect on the euploid rate of embryos, leading to a lower live birth rate.

• Placebo comparator

  Antagonist group

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

• Active comparator

  PPOS group

  Women will receive oral medroxyprogesterone 10 mg daily or Duphaston 10mg bd from Day 3 till the day of ovulation trigger. Gonadotrophin (human menopausal gonadotrophin or recombinant FSH) injections will be started. Ovarian response will be monitored by transvaginal scanning with or without serum hormonal level. Human chorionic gonadotrophin (hCG 1,000 IU) and GnRH agonist (decepepty 0.2mg) will be given for triggering of final maturation when at least 3 follicles reach \>17mm in diameter. Blood will be checked for serum estradiol and progesterone levels. Transvaginal USS-guided oocyte retrieval will be performed 36 hours after the trigger.

1. euploid blastocyst formation rate

   Time frame · 2 months

   Registry description

   Euploid blastocysts per injected MII oocyte