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

Study Overview
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Brief Summary
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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.

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

Conditions
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Poor Ovarian Response

Intervention / Treatment
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* Drug: Ovidrel
* Drug: Troprilin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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poor ovarian response