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

NCT ID: NCT04717752

Last Updated: 2021-01-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 310 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-20
• Study Completion Date: 2021-12-31

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.

Conditions

Poor Ovarian Response

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Double trigger unit

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

Group Type: EXPERIMENTAL

Ovidrel

Intervention Type: DRUG

recombinant human chorionic gonadotropin for injection

Troprilin

Intervention Type: DRUG

triptorelin acetate injection

HCG trigger unit

HCG: 6000IU (Ovidrel: 250ug)

Group Type: SHAM_COMPARATOR

Ovidrel

Intervention Type: DRUG

recombinant human chorionic gonadotropin for injection

Interventions

Ovidrel

recombinant human chorionic gonadotropin for injection

Intervention Type: DRUG

Troprilin

triptorelin acetate injection

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Nanjing University

OTHER

Sponsor Role: lead

Responsible Party

Li-jun Ding

Reproductive Medicine Center, Drum Tower Hospital Affiliated to Nanjing University Medical College

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Haixiang Sun

Role: primary

stevensunz@163.com

+86 025 83107188

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Other Identifiers

SZ-POR-DTMAR-2020

Identifier Type: -

Identifier Source: org_study_id