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

Nanjing University

Status: Unknown

Conditions: Poor Ovarian Response

Treatments: Drug: Troprilin; Drug: Ovidrel

Study type: Interventional

Funder types: Other

Identifiers

NCT04717752

SZ-POR-DTMAR-2020

Details and patient eligibility

About

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.

Enrollment: 310 estimated patients

Sex: Female

Ages: 21 to 42 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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310 participants in 2 patient groups

Double trigger unit

Experimental group

Description:

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

Treatment:

Drug: Troprilin

Drug: Ovidrel

HCG trigger unit

Sham Comparator group

Description:

HCG: 6000IU (Ovidrel: 250ug)

Treatment:

Drug: Ovidrel