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Comparison of clinical outcomes, economic benefits, and time to pregnancy among Poseidon group 2 patients undergoing IVF/ICSI using antagonist versus PPOS

comparison of clinical outcomes, economic benefits, and time to pregnancy among Poseidon group 2 patients undergoing IVF/ICSI using Antagonist versus PPOS

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200056027
Enrollment
Unknown
Registered
2022-01-31
Start date
2022-02-01
Completion date
Unknown
Last updated
2024-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Interventions

Experimental group:Antagonist regiments control hyperovulation
Control group:PPOS regiments control hyperovulation

Sponsors

The First Hospital of Lanzhou University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
35 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Meet Poseidon Group 2 criteria, age >= 35; 2. Normal ovarian reserve: number of antrum follicles >= 5, AMH >= 1.2 ng/mL; 3. Number of eggs obtained by previous standard stimulation <= 9; 4. In this center for the first or second time of tube assisted pregnancy; 5. Body mass index (BMI)18.0 - 25.0 kg/m2 (including boundary value).

Exclusion criteria

Exclusion criteria: 1. Endocrine and metabolic diseases, such as hyperprolactinemia, uncontrolled thyroid and adrenal dysfunction, diabetes, hyperandrogenemia, etc.; 2. Related diseases that affect IVF/ICSI pregnancy outcome, such as untreated hydrosalpinx, uterine fibroids >= 4 cm, severe adenomyosis, endometriosis stage III or IV, uterine malformations, untreated endometrial lesions, such as intrauterine polyps, submucosal myomas, intrauterine adhesions, endometrial hyperplasia, endometritis, thin endometrium (transplantation thickness =3 times); 4. Unexplained abnormal (non-menstrual) vaginal bleeding; 5. Known clinically significant abnormal cervical cytology results observed within the first 3 months of randomization (unless the clinical significance has been resolved); 6. Patients with past or current history of malignant tumors such as ovary, breast, uterus, pituitary gland or hypothalamus; 7. Known chromosomal abnormalities that researchers judge to be clinically significant; Or receiving donor eggs or abnormal genetic screening/preimplantation genetic diagnosis (PGS/PGD); 8. Hepatitis B, AIDS, or syphilis positive; 9. Known past or current thromboembolic disease; 10. Patients with acute urinary and reproductive system infection or active pelvic inflammatory disease; 11. Judging by the researchers, with serious heart, brain, liver, kidney, and hematopoietic system, such as disease, including serum AST and ALT more than 2 times the upper limit of normal scope or Cr cap of 1.5 times more than normal range, the researchers determine the clinical significance of 12-lead electrocardiogram indicates a long QT, arrhythmia or acute myocardial ischemia, etc.; 12. With a history of central nervous system diseases and epilepsy, and/or uncooperative mental state; 13. Women who had an ectopic pregnancy or any pregnancy within the preceding 3 months of the randomization, positive blood pregnancy test or lactation; 14. Use of fertility regulators (such as clomiphene citrate, gonadotropin, metformin or oral contraceptives, etc.) within the first 3 months of randomization; 15. Hormone drugs were used randomly within the first 3 months; 16. Patients with contraindications or allergies to recombinant human follicle stimulating hormone injection, triptorelin acetate, rhCG or progesterone; 17. Have a habit of smoking (more than 5 cigarettes per day in the previous 3 months) or a habit of drinking (more than 28 units of alcohol per week, 1 unit = 285 mL beer or 25 mL 40% alcohol spirits or 75 mL wine); 18. Past drug abuse, abuse of medication, etc.; 19. Exposed to teratogenic radiation, drugs or medications and in the active stage; 20. Patients who have participated in other clinical trials and are using the study drug or are participating in other clinical trials within the preceding 3 months of randomization; 21. Allergic to drugs used in this study.

Design outcomes

Primary

MeasureTime frame
Cumulative clinical pregnancy rate;

Secondary

MeasureTime frame
Persistent pregnancy rate;Early abortion rate;The duration of pregnancy is reached;Number of eggs;Economic benefit ratio;

Countries

China

Contacts

Public ContactLili Zhang

The First Hospital of Lanzhou University

zhang_lili1981@126.com+86 13893486294

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026