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Poor Ovarian ResponseNCT04717752

A Randomized Controlled Study of Different Trigger Modes of Antagonist Regimen in Patients With Low Ovarian Reserve

A study testing Ovidrel and Troprilin in people with Poor Ovarian Response, run by Nanjing University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Assisted reproductive technology (ART), especially controlled ovarian stimulation (COS), significantly increased clinical pregnancy rates among infertile patients. However, about 9% to 24% of patients had poor ovarian response to gonadotropins (GNS) stimulation, which was called poor ovarian response (POR). Read more about this study

Who is it for?
Ages 21 to 42 years, women only
Conditions the study is for
Poor Ovarian Response
What is being tested?
Ovidrel and Troprilin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
310 participants
Where
1 siteChina
Study dates
20 Jan 2021to 31 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 42 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age less than or equal to 42 years old, AFC<5 and or AMH<1.2ng/ml ② Adopt antagonist program for controlled ovulation hyperstimulation (COH); patients with fresh cycle transplantation;
  • Accept conventional IVF or intracytoplasmic sperm injection (ICSI);
  • The ART treatment cycle is less than 3 times.

Who cannot join

  • Abnormal chromosome karyotype;
  • Severe endometriosis;
  • Abnormal thyroid function; ④ Pregnancy contraindications; ⑤ Past history of ovarian tumors or after receiving radiotherapy

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210008

    Haixiang Sun, +86 025 83107188, stevensunz@163.com

    Recruiting

Other trials in China

About this study

Assisted reproductive technology (ART), especially controlled ovarian stimulation (COS), significantly increased clinical pregnancy rates among infertile patients. However, about 9% to 24% of patients had poor ovarian response to gonadotropins (GNS) stimulation, which was called poor ovarian response (POR). In recent years, the diagnosis and treatment of patients with low fertility is the challenge for reproductive medicine. To better demonstrate the effectiveness of various interventions and distinguish the different subgroups of patients, 2016 POSEIDON (Patient-Oriented Strategies Encompassing Individualized Oocyte Number) standard changed low reaction into low prognosis of patient-oriented individual strategies to obtain eggs. For patients in group 3 and group 4 classified by POSEIDON, ovarian reserve function decline, follicular development desynchrony and low numbers of oocytes obtained lead to poor prognosis. In 2020, the prognosis based on Delphi method of assisted reproductive technology to treat low crowd diagnosis expert opinion in China recommended to give these patients conventional cosine solutions such as antagonist. In the first cycle, follicle stimulating hormone (FSH) starting dose of 225 ~ 300 iu is suggested to achieve plenty of ovarian stimulation for standards and maximize the benefits of superovulation. Because of the particularity of luteal support in the antagonist regimen, it is of great clinical significance to explore the trigger mode and combination mode of luteal support in the antagonist regimen for patients with poor prognosis.

Being tested
Ovidrel, Troprilin
Keywords
poor ovarian response

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OvidrelDrug

    recombinant human chorionic gonadotropin for injection

  • TroprilinDrug

    triptorelin acetate injection

Study groups in NCT04717752
Study groupRoleWhat they receive
Double trigger unitExperimentalHCG: 6000IU (Ovidrel: 250ug) + GnRH-a (Troprilin) 0.2mg
Receives: Drug: Ovidrel; Drug: Troprilin
HCG trigger unitSham comparatorHCG: 6000IU (Ovidrel: 250ug)
Receives: Drug: Ovidrel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical pregnancy rate in each transplantation cycle

    number of pregnant cases are confirmed by ultrasound/ total number of transplanted

    Measured: 6 weeks

Secondary outcomes (6)

  1. Rate of cancelled cycle

    number of cancelled cycles/ number of total cycles

    Measured: 6 weeks

  2. Number of mature eggs

    number of matured oocytes

    Measured: 6 weeks

  3. Number of high-quality embryos

    number of D3 high quality embryos (≥7 scores)

    Measured: 6 weeks

  4. Implantation rate

    number of gestational sacs/ number of transplanted embryos

    Measured: 6 weeks

  5. Early abortion rate

    number of miscarriage cases/ number of pregnant cases confirmed by ultrasound

    Measured: 6 weeks

  6. Cumulative pregnancy rate per stimulation cycle

    number of pregnant cases which are confirmed by ultrasound/ total number of stimulation cycle

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2021
  2. Study start20 Jan 2021 (estimated)
  3. Primary completion31 Oct 2021 (estimated)
  4. Study completion31 Dec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
310 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04717752
Sponsor's protocol ID
SZ-POR-DTMAR-2020
Status last verified
Jan 2021
First submitted
18 Jan 2021
Last updated
28 Jan 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ferraretti AP, La Marca A, Fauser BC, Tarlatzis B, Nargund G, Gianaroli L; ESHRE working group on Poor Ovarian Response Definition. ESHRE consensus on the definition of 'poor response' to ovarian stimulation for in vitro fertilization: the Bologna criteria. Hum Reprod. 2011 Jul;26(7):1616-24. doi: 10.1093/humrep/der092. Epub 2011 Apr 19.

    PubMed 21505041

  • Poseidon Group (Patient-Oriented Strategies Encompassing IndividualizeD Oocyte Number); Alviggi C, Andersen CY, Buehler K, Conforti A, De Placido G, Esteves SC, Fischer R, Galliano D, Polyzos NP, Sunkara SK, Ubaldi FM, Humaidan P. A new more detailed stratification of low responders to ovarian stimulation: from a poor ovarian response to a low prognosis concept. Fertil Steril. 2016 Jun;105(6):1452-3. doi: 10.1016/j.fertnstert.2016.02.005. Epub 2016 Feb 26. No abstract available.

    PubMed 26921622

  • Orvieto R. Triggering final follicular maturation--hCG, GnRH-agonist or both, when and to whom? J Ovarian Res. 2015 Aug 21;8:60. doi: 10.1186/s13048-015-0187-6.

    PubMed 26293447

  • Nakano R, Mizuno T, Kotsuji F, Katayama K, Wshio M, Tojo S. "Triggering" of ovulation after infusion of synthetic luteinizing hormone releasing factor (LRF). Acta Obstet Gynecol Scand. 1973;52(3):269-72. doi: 10.3109/00016347309158325. No abstract available.

    PubMed 4582787

  • Gonen Y, Balakier H, Powell W, Casper RF. Use of gonadotropin-releasing hormone agonist to trigger follicular maturation for in vitro fertilization. J Clin Endocrinol Metab. 1990 Oct;71(4):918-22. doi: 10.1210/jcem-71-4-918.

    PubMed 2119392

  • Griesinger G, Diedrich K, Devroey P, Kolibianakis EM. GnRH agonist for triggering final oocyte maturation in the GnRH antagonist ovarian hyperstimulation protocol: a systematic review and meta-analysis. Hum Reprod Update. 2006 Mar-Apr;12(2):159-68. doi: 10.1093/humupd/dmi045. Epub 2005 Oct 27.

    PubMed 16254001

  • Griesinger G, Kolibianakis EM, Papanikolaou EG, Diedrich K, Van Steirteghem A, Devroey P, Ejdrup Bredkjaer H, Humaidan P. Triggering of final oocyte maturation with gonadotropin-releasing hormone agonist or human chorionic gonadotropin. Live birth after frozen-thawed embryo replacement cycles. Fertil Steril. 2007 Sep;88(3):616-21. doi: 10.1016/j.fertnstert.2006.12.006. Epub 2007 Apr 23.

    PubMed 17451691

  • Youssef MA, Van der Veen F, Al-Inany HG, Mochtar MH, Griesinger G, Nagi Mohesen M, Aboulfoutouh I, van Wely M. Gonadotropin-releasing hormone agonist versus HCG for oocyte triggering in antagonist-assisted reproductive technology. Cochrane Database Syst Rev. 2014 Oct 31;2014(10):CD008046. doi: 10.1002/14651858.CD008046.pub4.

    PubMed 25358904

  • Griesinger G, Meldrum D. Introduction: Management of the luteal phase in assisted reproductive technology. Fertil Steril. 2018 May;109(5):747-748. doi: 10.1016/j.fertnstert.2018.02.009.

    PubMed 29778366

  • Lawrenz B, Coughlan C, Fatemi HM. Individualized luteal phase support. Curr Opin Obstet Gynecol. 2019 Jun;31(3):177-182. doi: 10.1097/GCO.0000000000000530.

    PubMed 30855289

  • Griffin D, Benadiva C, Kummer N, Budinetz T, Nulsen J, Engmann L. Dual trigger of oocyte maturation with gonadotropin-releasing hormone agonist and low-dose human chorionic gonadotropin to optimize live birth rates in high responders. Fertil Steril. 2012 Jun;97(6):1316-20. doi: 10.1016/j.fertnstert.2012.03.015. Epub 2012 Apr 3.

    PubMed 22480822

  • Schachter M, Friedler S, Ron-El R, Zimmerman AL, Strassburger D, Bern O, Raziel A. Can pregnancy rate be improved in gonadotropin-releasing hormone (GnRH) antagonist cycles by administering GnRH agonist before oocyte retrieval? A prospective, randomized study. Fertil Steril. 2008 Oct;90(4):1087-93. doi: 10.1016/j.fertnstert.2007.07.1316. Epub 2007 Nov 26.

    PubMed 18023439

  • Li S, Zhou D, Yin T, Xu W, Xie Q, Cheng D, Yang J. Dual trigger of triptorelin and HCG optimizes clinical outcome for high ovarian responder in GnRH-antagonist protocols. Oncotarget. 2018 Jan 4;9(4):5337-5343. doi: 10.18632/oncotarget.23916. eCollection 2018 Jan 12.

    PubMed 29435182

  • Eftekhar M, Mojtahedi MF, Miraj S, Omid M. Final follicular maturation by administration of GnRH agonist plus HCG versus HCG in normal responders in ART cycles: An RCT. Int J Reprod Biomed. 2017 Jul;15(7):429-434.

    PubMed 29177244

  • Lin MH, Wu FS, Lee RK, Li SH, Lin SY, Hwu YM. Dual trigger with combination of gonadotropin-releasing hormone agonist and human chorionic gonadotropin significantly improves the live-birth rate for normal responders in GnRH-antagonist cycles. Fertil Steril. 2013 Nov;100(5):1296-302. doi: 10.1016/j.fertnstert.2013.07.1976. Epub 2013 Aug 28.

    PubMed 23993928

Questions about this trial

What is this clinical trial studying?

A study testing Ovidrel and Troprilin in people with Poor Ovarian Response, run by Nanjing University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical pregnancy rate in each transplantation cycle (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04717752, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021.

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