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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04717752
Enrollment
310
Registered
2021-01-22
Start date
2021-01-20
Completion date
2021-12-31
Last updated
2021-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Poor Ovarian Response

Keywords

poor ovarian response

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.

Interventions

recombinant human chorionic gonadotropin for injection

DRUGTroprilin

triptorelin acetate injection

Sponsors

Nanjing University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
21 Years to 42 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Clinical pregnancy rate in each transplantation cycle6 weeksnumber of pregnant cases are confirmed by ultrasound/ total number of transplanted

Secondary

MeasureTime frameDescription
Number of mature eggs6 weeksnumber of matured oocytes
Number of high-quality embryos6 weeksnumber of D3 high quality embryos (≥7 scores)
Rate of cancelled cycle6 weeksnumber of cancelled cycles/ number of total cycles
Early abortion rate6 weeksnumber of miscarriage cases/ number of pregnant cases confirmed by ultrasound
Cumulative pregnancy rate per stimulation cycle6 weeksnumber of pregnant cases which are confirmed by ultrasound/ total number of stimulation cycle
Implantation rate6 weeksnumber of gestational sacs/ number of transplanted embryos

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026