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Effect of modified GnRH antagonist protocol on the outcome of in vitro fertilization-embryo transfer in patients with normal ovarian response: a multicenter, randomized, controlled trial

Effect of modified GnRH antagonist protocol on the outcome of in vitro fertilization-embryo transfer in patients with normal ovarian response: a multicenter, randomized, open-label, standard treatment parallel-controlled, non-inferiority to superiority clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083263
Enrollment
Unknown
Registered
2024-04-19
Start date
2024-04-24
Completion date
Unknown
Last updated
2024-04-22

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

Conditions

infertility

Interventions

Modified antagonist protocol (study group):A fixed regimen of GnRH-antagonist was used for all study participants. Daily subcutaneous injections of the GnRH antagonist are administered from day 5 of o
Conventional antagonist protocol (control group):Daily subcutaneous injections of the GnRH antagonist are administered from day 5 of ovarian stimulation. Patients completed their treatment cycle witho

Sponsors

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
21 Years to 37 Years

Inclusion criteria

Inclusion criteria: 1. Age 1.2ng/ml, antral follicle count (AFC) > 7; 3. First IVF/ICSI cycle; 4. 18.5kg/m2 = BMI 6 and < 20.

Exclusion criteria

Exclusion criteria: 1. Polycystic ovary syndrome, endometriosis, and patients were planning cycles of PGT. 2. Recurrent spontaneous abortion. 3. Uterine abnormalities (such as a uterine malformation, adenomyosis, intrauterine adhesion, or sub-mucous myoma). 4. Hydrosalpinx without ligation or resection surgery. 5. Chromosomal abnormalities. 6. Existence of factors that have a negative impact on the pregnancy outcome of fresh embryo transfer or not suitable for fresh embryos transfer, such as premature progesterone elevation, infection, bleeding, fever. 7. Patients who are at risk of OHSS, such as E2 = 5000pg/mL or number of growing follicles = 20, or patients developed any sign or symptoms of OHSS. 8. Untreated medical conditions that are contraindications to IVF procedures or pregnancy, such as uncontrolled hypertension, symptomatic heart disease, poorly controlled type 1 or type 2 diabetes, poor liver function, renal insufficiency, severe anemia, previous history of thrombosis, cerebrovascular disease. 9. Patients receiving sperm from testicular sperm extraction (TESE), testicular sperm aspiration (TESA), or micro TESE.

Design outcomes

Primary

MeasureTime frame
Live birth rate per fresh cycle;

Secondary

MeasureTime frame
Serum estradiol (E2) level on hCG day;Serum progesterone (P) level on hCG day;Premature LH surge rate;Early ovulation rate;Number of oocytes retrieved;Number of available embryos;Blastocyst formation rate;Good-quality embryo rate;Clinical pregnancy rate;Early miscarriage rate;Ongoing pregnancy rate;Fresh cycle embryo transfer cancellation rate;

Countries

China

Contacts

Public ContactJin Lei

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

ljin@tjh.tjmu.edu.cn+86 137 0710 5776

Outcome results

None listed

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