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

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ClinicalTrials.gov Identifier: NCT04717752
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : January 28, 2021
Sponsor:
Information provided by (Responsible Party):
Li-jun Ding, Nanjing University

Brief 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). 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.

Condition or disease Intervention/treatment Phase
Poor Ovarian Response Drug: Ovidrel Drug: Troprilin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 310 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study of Different Trigger Modes of Antagonist Regimen in Patients With Low Ovarian Reserve
Estimated Study Start Date : January 20, 2021
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Double trigger unit
HCG: 6000IU (Ovidrel: 250ug) + GnRH-a (Troprilin) 0.2mg
Drug: Ovidrel
recombinant human chorionic gonadotropin for injection

Drug: Troprilin
triptorelin acetate injection

Sham Comparator: HCG trigger unit
HCG: 6000IU (Ovidrel: 250ug)
Drug: Ovidrel
recombinant human chorionic gonadotropin for injection




Primary Outcome Measures :
  1. Clinical pregnancy rate in each transplantation cycle [ Time Frame: 6 weeks ]
    number of pregnant cases are confirmed by ultrasound/ total number of transplanted


Secondary Outcome Measures :
  1. Rate of cancelled cycle [ Time Frame: 6 weeks ]
    number of cancelled cycles/ number of total cycles

  2. Number of mature eggs [ Time Frame: 6 weeks ]
    number of matured oocytes

  3. Number of high-quality embryos [ Time Frame: 6 weeks ]
    number of D3 high quality embryos (≥7 scores)

  4. Implantation rate [ Time Frame: 6 weeks ]
    number of gestational sacs/ number of transplanted embryos

  5. Early abortion rate [ Time Frame: 6 weeks ]
    number of miscarriage cases/ number of pregnant cases confirmed by ultrasound

  6. Cumulative pregnancy rate per stimulation cycle [ Time Frame: 6 weeks ]
    number of pregnant cases which are confirmed by ultrasound/ total number of stimulation cycle



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Ages Eligible for Study:   21 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04717752


Locations
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China, Jiangsu
Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School Recruiting
Nanjing, Jiangsu, China, 210008
Contact: Haixiang Sun    +86 025 83107188    stevensunz@163.com   
Sponsors and Collaborators
Nanjing University
Publications:

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Responsible Party: Li-jun Ding, Reproductive Medicine Center, Drum Tower Hospital Affiliated to Nanjing University Medical College, Nanjing University
ClinicalTrials.gov Identifier: NCT04717752    
Other Study ID Numbers: SZ-POR-DTMAR-2020
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: January 28, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Li-jun Ding, Nanjing University:
poor ovarian response
Additional relevant MeSH terms:
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Chorionic Gonadotropin
Reproductive Control Agents
Physiological Effects of Drugs