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Trial · Interventional

Active, not recruitingNot applicableRegistry data

PPOS vs GnRH Antagonist in Ovarian Stimulation (ProGanOS Study)

Short name ProGanOS

NCTNCT06378268 (opens ClinicalTrials.gov in a new tab)Other id05/24/DD-BVMD
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Active, not recruiting
Phase
Not applicable
Enrollment
626 participants (estimated)
Sponsor
Mỹ Đức Hospital · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Vietnam

Start
24 Apr 2024
Primary completion
30 Jun 2026 (estimated)
Completion
30 Sept 2026 (estimated)
First posted
22 Apr 2024
Last update posted
20 Mar 2026
Conditions
Progestins Primed Ovarian Stimulation

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2024202520262027
  1. N/A

    ProGanOS

    NCT06378268

    24 Apr 2024 to est. 30 Sept 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This non-inferiority randomized controlled trial will be conducted at My Duc Hospital, Ho Chi Minh City, Vietnam. This study compares the effectiveness of Progestin-Primed Ovarian stimulation versus GnRH protocol for ovarian stimulation in IVF treatment. Participants will be randomly assigned in a 1:1 ratio to receive Progestins or GnRH antagonists.

Interventions

  • Dydrogesterone 10 mgDrug
  • Cetrorelix 0.25 mgDrug

Arms2

  • Active comparator

    Progestins Primed Ovarian stimulation group

    PPOS group: Recombinant FSH 150-300 IU/day will start from day 2 to day 4 of menstruation. The initial FSH dose will be chosen based on age, anti-Müllerian hormone (AMH) level, antral follicle count (AFC), and body mass index (BMI). The FSH dosage will be fixed during ovarian stimulation. Dydrogesterone (Duphaston, Abbott, USA) 20mg/day will start on the day of gonadotropin injection to the oocyte maturation trigger night.

  • Active comparator

    GnRH antagonist group

    GnRH antagonist group: Recombinant FSH 150-300 IU/day will be given from day 2 to day 4 of menstruation. The initial FSH dose will be chosen based on age, anti-Müllerian hormone (AMH) level, antral follicle count (AFC), and body mass index (BMI). The FSH dosage will be fixed during ovarian stimulation. Cetrorelix (Cetrotide, Merck, Germany) 0.25mg/day will be given from day 5 of stimulation by the oocyte maturation trigger day.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Ongoing pregnancy

    Time frame · At 10 weeks after embryo(s) placement

    Registry description

    defined as pregnancy with a detectable heart rate at 12 weeks gestation or beyond

Secondary outcomes(20)

  1. The incidence of premature LH surge

    Time frame · On the day having indication of oocyte maturation

    Registry description

    LH level of ≥ 10 mIU/mL occurring before the criteria of oocyte maturation administration is met

  2. The incidence of premature progesterone elevation

    Time frame · On the day having indication of oocyte maturation

    Registry description

    A progesterone level of ≥1.0 ng/mL occurring before the criteria of oocyte maturation administration is met

  3. Number of oocytes retrieved

    Time frame · On the oocyte(s) retrieval day

    Registry description

    The number of oocyte retrieved

  4. Number of mature oocytes

    Time frame · On the oocyte(s) retrieval day

    Registry description

    The number of MII oocytes

  5. Number of day 3 embryos

    Time frame · At 62-66 hours after ICSI

    Registry description

    The number of day 3 embryos

  6. Number of day 5 embryos

    Time frame · At 112-116 hours after ICSI

    Registry description

    The number of day 5 embryos

  7. Number of good quality day 3 embryos

    Time frame · At 62-66 hours after ICSI

    Registry description

    Number of grade 1 and grade 2 day 3 embryos (acccording to Alpha Scientists in Reproductive Medicine and ESHRE Special Interest Group of Embryology, 2011)

  8. Number of good quality day 5 embryos

    Time frame · At 112-116 hours after ICSI

    Registry description

    Number of grade 1 and grade 2 day 5 blastocysts (acccording to Alpha Scientists in Reproductive Medicine and ESHRE Special Interest Group of Embryology, 2011)

  9. Number of frozen embryos

    Time frame · at 112-116 hours after ICSI

    Registry description

    the number of frozen embryos/blastocysts

  10. Incidence of Ovarian hyperstimulation syndrome

    Time frame · At 2 weeks after trigger

    Registry description

    Ovarian hyperstimulation syndrome (OHSS) is a potentially lethal iatrogenic complication of the early luteal phase or/and early pregnancy after ovulation induction (OI) or ovarian stimulation (OS). OHSS was evaluated if symptoms were reported by the patient. OHSS was classified using the flow diagram developed by (Humaidan et al., 2016)

  11. Positive ß-hCG test

    Time frame · At 2 weeks after embryo(s) placement

    Registry description

    Serum human chorionic gonadotropin level greater than 25 mIU/mL

  12. Clinical pregnancy

    Time frame · at 6 weeks or more after the onset of last menstrual period

    Registry description

    diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy at 6 weeks or more after the onset of the last menstrual period. In addition to intra-uterine pregnancy, it includes a clinically documented ectopic pregnancy.

  13. Ectopic pregnancy

    Time frame · at 6 weeks after the onset of last menstrual period

    Registry description

    A pregnancy outside the uterine cavity, diagnosed by ultrasound, surgical visualization or histopathology

  14. Early miscarriage <12 weeks

    Time frame · At 12 weeks of gestation

    Registry description

    Spontaneous loss of intra-uterine pregnancy up to 12 weeks of gestation

  15. Late miscariage 12-< 22 weeks

    Time frame · between 12 to 22 completed weeks of gestational age

    Registry description

    The spontaneous loss of an intra-uterine pregnancy between 12 to 22 completed weeks of gestational age

  16. Live birth rate

    Time frame · At 22 weeks of gestation

    Registry description

    Defined as the complete expulsion or extraction from a woman of a product of fertilization, after 22 completed weeks of gestational age; which, after such separation, breathes or shows any other evidence of life, such as heartbeat, umbilical cord pulsation or definite movement of voluntary muscles, irrespective of whether the umbilical cord has been cut or the placenta is attached. A birth weight of 500 grams or more can be used if gestational age is unknown. Twins counted as one live birth.

  17. Gestational age at birth

    Time frame · At birth

    Registry description

    Calculated by gestational age of all live births

  18. Mode of delivery

    Time frame · At birth

    Registry description

    vaginal delivery, C-section (elective, suspected fetal distress, non-progressive labor)

  19. Birth weight

    Time frame · At birth

    Registry description

    Weight of the newborn measured right after delivery

  20. Very low birth weight

    Time frame · At birth

    Registry description

    Birth weight less than 1.500 g

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 1994

14 results

A single injection of a gonadotropin-releasing hormone (GnRH) antagonist (Cetrorelix) postpones the luteinizing hormone (LH) surge: further evidence for the role of GnRH during the LH surge.

Leroy et al. 1994Fertility and sterilitycited by 52

PMID 8062939DOI 10.1016/s0015-0282(16)56932-5PUB-08062939

Full text at the publisher14 results
Publisher pageSee results (14)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultMessinis IE. Ovarian feedback, mechanism of action and possible clinical implications. Hum Reprod Update. 2006 Sep-Oct;12(5):557-71. doi: 10.1093/humupd/dml020. Epub 2006 May 3. PMID 16672246
  • ResultPapanikolaou EG, Kolibianakis EM, Pozzobon C, Tank P, Tournaye H, Bourgain C, Van Steirteghem A, Devroey P. Progesterone rise on the day of human chorionic gonadotropin administration impairs pregnancy outcome in day 3 single-embryo transfer, while has no effect on day 5 single blastocyst transfer. Fertil Steril. 2009 Mar;91(3):949-52. doi: 10.1016/j.fertnstert.2006.12.064. Epub 2007 Jun 6. PMID 17555751
  • ResultVan Vaerenbergh I, Fatemi HM, Blockeel C, Van Lommel L, In't Veld P, Schuit F, Kolibianakis EM, Devroey P, Bourgain C. Progesterone rise on HCG day in GnRH antagonist/rFSH stimulated cycles affects endometrial gene expression. Reprod Biomed Online. 2011 Mar;22(3):263-71. doi: 10.1016/j.rbmo.2010.11.002. Epub 2010 Nov 13. PMID 21273126
  • ResultDroesch K, Muasher SJ, Brzyski RG, Jones GS, Simonetti S, Liu HC, Rosenwaks Z. Value of suppression with a gonadotropin-releasing hormone agonist prior to gonadotropin stimulation for in vitro fertilization. Fertil Steril. 1989 Feb;51(2):292-7. doi: 10.1016/s0015-0282(16)60493-4. PMID 2492234
  • Resultvan Loenen AC, Huirne JA, Schats R, Hompes PG, Lambalk CB. GnRH agonists, antagonists, and assisted conception. Semin Reprod Med. 2002 Nov;20(4):349-64. doi: 10.1055/s-2002-36713. PMID 12536358
  • ResultAl-Inany HG, Youssef MA, Aboulghar M, Broekmans F, Sterrenburg M, Smit J, Abou-Setta AM. Gonadotrophin-releasing hormone antagonists for assisted reproductive technology. Cochrane Database Syst Rev. 2011 May 11;(5):CD001750. doi: 10.1002/14651858.CD001750.pub3. PMID 21563131
  • ResultToftager M, Bogstad J, Bryndorf T, Lossl K, Roskaer J, Holland T, Praetorius L, Zedeler A, Nilas L, Pinborg A. Risk of severe ovarian hyperstimulation syndrome in GnRH antagonist versus GnRH agonist protocol: RCT including 1050 first IVF/ICSI cycles. Hum Reprod. 2016 Jun;31(6):1253-64. doi: 10.1093/humrep/dew051. Epub 2016 Apr 8. PMID 27060174
  • ResultGriesinger G, Schultz L, Bauer T, Broessner A, Frambach T, Kissler S. Ovarian hyperstimulation syndrome prevention by gonadotropin-releasing hormone agonist triggering of final oocyte maturation in a gonadotropin-releasing hormone antagonist protocol in combination with a "freeze-all" strategy: a prospective multicentric study. Fertil Steril. 2011 May;95(6):2029-33, 2033.e1. doi: 10.1016/j.fertnstert.2011.01.163. Epub 2011 Mar 2. PMID 21371705
  • ResultKuang 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. PMID 25956370
  • ResultWang Y, Chen Q, Wang N, Chen H, Lyu Q, Kuang Y. Controlled Ovarian Stimulation Using Medroxyprogesterone Acetate and hMG in Patients With Polycystic Ovary Syndrome Treated for IVF: A Double-Blind Randomized Crossover Clinical Trial. Medicine (Baltimore). 2016 Mar;95(9):e2939. doi: 10.1097/MD.0000000000002939. PMID 26945402
  • ResultZhu X, Ye H, Fu Y. The Utrogestan and hMG protocol in patients with polycystic ovarian syndrome undergoing controlled ovarian hyperstimulation during IVF/ICSI treatments. Medicine (Baltimore). 2016 Jul;95(28):e4193. doi: 10.1097/MD.0000000000004193. PMID 27428219
  • ResultMassin 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. PMID 28062551
  • ResultVuong LN, Dang VQ, Ho TM, Huynh BG, Ha DT, Pham TD, Nguyen LK, Norman RJ, Mol BW. IVF Transfer of Fresh or Frozen Embryos in Women without Polycystic Ovaries. N Engl J Med. 2018 Jan 11;378(2):137-147. doi: 10.1056/NEJMoa1703768. PMID 29320655
  • ResultShrestha D, La X, Feng HL. Comparison of different stimulation protocols used in in vitro fertilization: a review. Ann Transl Med. 2015 Jun;3(10):137. doi: 10.3978/j.issn.2305-5839.2015.04.09. PMID 26207230
  • ResultFerin M, Rosenblatt H, Carmel PW, Antunes JL, Vande Wiele RL. Estrogen-induced gonadotropin surges in female rhesus monkeys after pituitary stalk section. Endocrinology. 1979 Jan;104(1):50-2. doi: 10.1210/endo-104-1-50. PMID 109276

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 40 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Woman aged 18-40 * BMI ≤ 25kg/m2 * AMH \> 1.2ng/mL or AFC \>5 * Having indication for IVF treatment * Agree to have frozen embryo(s) transfer * Not participating in any other clinical trials * Provision of written informed consent to participate Exclusion Criteria: * Undergoing IVF cycle with other protocols: Down-regulation, mild stimulation, Random start * Oocyte donation cycles * Undergoing vitrified oocyte accumulation * Oocyte cryopreservation * Cycle with PGT (Preimplatation genetic testing) * Women with PCOS * Women allergy to dydrogesterone, rFSH, GnRH antagonist

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