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Trial · Interventional

Status unknownNot applicableRegistry data

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

NCTNCT04717752 (opens ClinicalTrials.gov in a new tab)Other idSZ-POR-DTMAR-2020
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names Triptorelin (Trelstar, Decapeptyl), does not test it. It appears in the description.
  • Names hCG (human chorionic gonadotropin), does not test it. It appears in the description.

Overview

Status
Status unknown
Phase
Not applicable
Enrollment
310 participants (estimated)
Sponsor
Nanjing University · Other
Design
Randomized · Open label (no masking)
Countries
1 country

China

Start
20 Jan 2021 (estimated)
Primary completion
31 Oct 2021 (estimated)
Completion
31 Dec 2021 (estimated)
First posted
22 Jan 2021
Last update posted
28 Jan 2021
Conditions
Poor Ovarian Response

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20212022
  1. N/A

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

    NCT04717752

    est. 20 Jan 2021 to est. 31 Dec 2021

Registry summary

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

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.

Interventions

  • OvidrelDrug
  • TroprilinDrug

Arms2

  • Experimental

    Double trigger unit

    HCG: 6000IU (Ovidrel: 250ug) + GnRH-a (Troprilin) 0.2mg

  • Sham comparator

    HCG trigger unit

    HCG: 6000IU (Ovidrel: 250ug)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Clinical pregnancy rate in each transplantation cycle

    Time frame · 6 weeks

    Registry description

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

Secondary outcomes(6)

  1. Rate of cancelled cycle

    Time frame · 6 weeks

    Registry description

    number of cancelled cycles/ number of total cycles

  2. Number of mature eggs

    Time frame · 6 weeks

    Registry description

    number of matured oocytes

  3. Number of high-quality embryos

    Time frame · 6 weeks

    Registry description

    number of D3 high quality embryos (≥7 scores)

  4. Implantation rate

    Time frame · 6 weeks

    Registry description

    number of gestational sacs/ number of transplanted embryos

  5. Early abortion rate

    Time frame · 6 weeks

    Registry description

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

  6. Cumulative pregnancy rate per stimulation cycle

    Time frame · 6 weeks

    Registry description

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

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

Studies4

Studies that cite this trial.

Studies with results

4 studies on this page

PubMed tag: none · 2018

2 results

Dual trigger of triptorelin and HCG optimizes clinical outcome for high ovarian responder in GnRH-antagonist protocols.

Li et al. 2018Oncotargetcited by 14

PMID 29435182PMC5797053DOI 10.18632/oncotarget.23916PUB-29435182

CC BY2 results
Download PDFSee results (2)

PubMed tag: none · 2017

4 results

Final follicular maturation by administration of GnRH agonist plus HCG versus HCG in normal responders in ART cycles: An RCT.

Eftekhar et al. 2017International journal of reproductive biomedicinecited by 24

PMID 29177244PMC5601934DOI 10.29252/ijrm.15.7.429PUB-29177244

CC BY4 results
Download PDFSee results (4)

Indexing hint: Observational study · 2013

4 results

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.

Lin et al. 2013Fertility and sterilitycited by 110

PMID 23993928DOI 10.1016/j.fertnstert.2013.07.1976PUB-23993928

Full text at the publisher4 results
Publisher pageSee results (4)

Indexing hint: Randomized controlled trial · 2008

7 results

Can pregnancy rate be improved in gonadotropin-releasing hormone (GnRH) antagonist cycles by administering GnRH agonist before oocyte retrieval? A prospective, randomized study.

Schachter et al. 2008Fertility and sterilitycited by 73

PMID 18023439DOI 10.1016/j.fertnstert.2007.07.1316PUB-18023439

Full text at the publisher7 results
Publisher pageSee results (7)

Eligibility

Who could join, as posted.

Sex
Female
Age
from 21 Years up to 42 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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. Exclusion Criteria: * Abnormal chromosome karyotype; * Severe endometriosis; * Abnormal thyroid function; ④ Pregnancy contraindications; ⑤ Past history of ovarian tumors or after receiving radiotherapy

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