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

Poor Ovarian Response Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04717752
• Other study ID #: SZ-POR-DTMAR-2020
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2021
• Source: Nanjing University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 310
• Est. completion date: December 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 42 Years

Eligibility

Inclusion Criteria:

• Age less than or equal to 42 years old, AFC<5 and or AMH<1.2ng/ml ? 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; ? Pregnancy contraindications; ? Past history of ovarian tumors or after receiving radiotherapy

Related Conditions & MeSH terms

• Poor Ovarian Response

Intervention

Drug:
• Ovidrel
recombinant human chorionic gonadotropin for injection
• Troprilin
triptorelin acetate injection

Locations

Country	Name	City	State
China	Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing University

Country where clinical trial is conducted

China, 

References & Publications (26)

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rate in each transplantation cycle	number of pregnant cases are confirmed by ultrasound/ total number of transplanted	6 weeks
Secondary	Rate of cancelled cycle	number of cancelled cycles/ number of total cycles	6 weeks
Secondary	Number of mature eggs	number of matured oocytes	6 weeks
Secondary	Number of high-quality embryos	number of D3 high quality embryos (=7 scores)	6 weeks
Secondary	Implantation rate	number of gestational sacs/ number of transplanted embryos	6 weeks
Secondary	Early abortion rate	number of miscarriage cases/ number of pregnant cases confirmed by ultrasound	6 weeks
Secondary	Cumulative pregnancy rate per stimulation cycle	number of pregnant cases which are confirmed by ultrasound/ total number of stimulation cycle	6 weeks