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Comparison of IVF Outcomes Between PPOS and Antagonist Protocols in Women With PCOS

ConditionsPolycystic Ovary Syndrome (PCOS)Female Infertility
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorHanoi General Hospital (Vietnam)

About this trial

This study aims to compare the outcomes of two ovarian stimulation protocols used in in vitro fertilization (IVF): the progestin-primed ovarian stimulation (PPOS) protocol and the GnRH antagonist protocol.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women aged 18-40 years

Diagnosed with polycystic ovary syndrome (PCOS) according to the modified Rotterdam criteria (2004) (≥2 of 3: oligo/anovulation, hyperandrogenism, or polycystic ovarian morphology on ultrasound)

Indicated for in vitro fertilization (IVF) due to PCOS alone or PCOS with other infertility factors (e.g., tubal factor, previous failed IUI)

Eligible for controlled ovarian stimulation for IVF

Disqualifiers

Uterine abnormalities that may impair implantation or pregnancy outcomes, including congenital uterine malformations, large fibroids distorting the uterine cavity, adenomyosis, or severe intrauterine pathology.

History of major ovarian or uterine surgery affecting ovarian reserve or uterine structure (e.g., ovarian cystectomy, endometriosis surgery, myomectomy, unilateral oophorectomy)

History of recurrent pregnancy loss (≥3 spontaneous miscarriages)

Known chromosomal abnormalities in either partner

Trial design

Design model

Parallel

Treatments tested in this trial

  • Progestin-Primed Ovarian Stimulation (PPOS)

    Drug

    Ovarian stimulation using a progestin-primed ovarian stimulation (PPOS) protocol, including gonadotropins combined with oral progestin for pituitary suppression during in vitro fertilization treatment.

  • GnRH Antagonist Protocol

    Drug

    Ovarian stimulation using a gonadotropin-releasing hormone (GnRH) antagonist protocol for pituitary suppression during in vitro fertilization treatment.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: PPOS ProtocolExperimental treatment 1 intervention
Group B: GnRH Antagonist ProtocolActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Ongoing pregnancy rate at 12 weeks

Ongoing pregnancy defined as a viable intrauterine pregnancy with fetal cardiac activity confirmed by ultrasound at or beyond 12 weeks of gestation.

Time frame
Up to 12 weeks after embryo transfer

Secondary outcomes

1

Number of Oocytes Retrieved

Total number of oocytes retrieved per ovarian stimulation cycle at the time of oocyte retrieval

Time frame
From ovarian stimulation start to oocyte retrieval (approximately 10-14 days)
2

Number of Mature (MII) Oocytes

Number of mature oocytes at the metaphase II (MII) stage identified at the time of oocyte retrieval

Time frame
At the time of oocyte retrieval (approximately 10-14 days after stimulation start)
3

Live birth rate

Live birth rate of live-born infants at ≥24 weeks of gestation or with birth weight ≥500 g and signs of life after birth.

Time frame
Up to delivery (approximately 9-12 months after embryo transfer)
4

Clinical pregnancy rate

Clinical pregnancy defined as the presence of a gestational sac with fetal cardiac activity confirmed by ultrasound

Time frame
6-7 weeks after embryo transfer

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hanoi General Hospital (Vietnam)

Lead sponsor

Hanoi Medical University

Sponsor institution

Source ClinicalTrials.gov
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