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

NCT04717752 | Unknown DMC

• 1 other identifier: SZ-POR-DTMAR-2020
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

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

Keywords

poor ovarian response

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy rate in each transplantation cycle

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

  6 weeks

Secondary Outcomes (6)

• Rate of cancelled cycle

  6 weeks

• Number of mature eggs

  6 weeks

• Number of high-quality embryos

  6 weeks

• Implantation rate

  6 weeks

• Early abortion rate

  6 weeks

Study Arms (2)

Double trigger unit

EXPERIMENTAL

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

Drug: Ovidrel; Drug: Troprilin

HCG trigger unit

SHAM COMPARATOR

HCG: 6000IU (Ovidrel: 250ug)

Drug: Ovidrel

Interventions

Ovidrel DRUG

recombinant human chorionic gonadotropin for injection

Double trigger unit; HCG trigger unit

Troprilin DRUG

triptorelin acetate injection

Double trigger unit

Eligibility Criteria

• Age: 21 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Abnormal chromosome karyotype;
• Severe endometriosis;
• Abnormal thyroid function; ④ Pregnancy contraindications; ⑤ Past history of ovarian tumors or after receiving radiotherapy

Sponsors & Collaborators

• Nanjing University: lead

Study Sites (1)

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

Nanjing, Jiangsu, 210008, China

RECRUITING

Related Publications (26)

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MeSH Terms

Interventions

Ovidrel

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reproductive Medicine Center, Drum Tower Hospital Affiliated to Nanjing University Medical College

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: January 22, 2021
• Study Start: January 20, 2021
• Primary Completion: October 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 28, 2021

Record last verified: 2021-01

Locations

CN (1)