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

January 27, 2021 updated by: Li-jun Ding, Nanjing University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

310

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Recruiting
        • Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 42 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Double trigger unit
HCG: 6000IU (Ovidrel: 250ug) + GnRH-a (Troprilin) 0.2mg
Drug: Ovidrel
recombinant human chorionic gonadotropin for injection
Drug: Troprilin
triptorelin acetate injection
Sham Comparator: HCG trigger unit
HCG: 6000IU (Ovidrel: 250ug)
Drug: Ovidrel
recombinant human chorionic gonadotropin for injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy rate in each transplantation cycle
Time Frame: 6 weeks
number of pregnant cases are confirmed by ultrasound/ total number of transplanted
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of cancelled cycle
Time Frame: 6 weeks
number of cancelled cycles/ number of total cycles
6 weeks
Number of mature eggs
Time Frame: 6 weeks
number of matured oocytes
6 weeks
Number of high-quality embryos
Time Frame: 6 weeks
number of D3 high quality embryos (≥7 scores)
6 weeks
Implantation rate
Time Frame: 6 weeks
number of gestational sacs/ number of transplanted embryos
6 weeks
Early abortion rate
Time Frame: 6 weeks
number of miscarriage cases/ number of pregnant cases confirmed by ultrasound
6 weeks
Cumulative pregnancy rate per stimulation cycle
Time Frame: 6 weeks
number of pregnant cases which are confirmed by ultrasound/ total number of stimulation cycle
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 20, 2021

Primary Completion (Anticipated)

October 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

January 18, 2021

First Submitted That Met QC Criteria

January 18, 2021

First Posted (Actual)

January 22, 2021

Study Record Updates

Last Update Posted (Actual)

January 28, 2021

Last Update Submitted That Met QC Criteria

January 27, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SZ-POR-DTMAR-2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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