| NCT ID | NCT04163133 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking University Third Hospital |
| Condition | IVF Outcome |
| Study Type | INTERVENTIONAL |
| Enrollment | 834 participants |
| Start Date | 2020-04-01 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 834 participants in total. It began in 2020-04-01 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The use of antagonist ovulation stimulation program is increasing year by year, because of its convenience, flexibility, and prevention effect of ovarian hyperstimulation syndrome. However, many researchers and clinicians believe that the clinical outcomes of antagonist regimens are worse than those of classical long-term regimens. Studies showed that the reasons for that maybe antagonist protocol results in poor effect on oocytes maturation or endometrial receptivity. At present, the trigger time of antagonist regimen is more than three follicles with diameters of ≥17 mm, which makes the duration of gonadotrophin application in antagonist regimen is shorter than that of long regimen. Whether the trigger time of antagonist regimen is too early to cause adverse effects on oocytes, embryos and eventual clinical outcomes is unknown. This study hopes to compare regular trigger timing and 1～2 days delay of trigger in ovarian stimulations by antagonist protocol，in order to study whether delay 1～2 days of trigger will get better clinical outcomes than regular trigger timing in ovarian stimulations by antagonist protocol in in vitro fertilization (IVF)/Intracytoplasmic sperm injection (ICSI). The results of this study will help infertile couples and clinicians to know and choose the optimal treatment in antagonist protocol.
Eligibility Criteria
Inclusion Criteria: * Age: ≥18 and \<42 years old * AFC: ≥5 and \<20 * AMH: ≥1.1 ng/mL and \<2.5 ng/mL * BMI: ≥18.5 Kg/m2 and \<29 Kg/m * First or second ART cycle * Regular menstrual cycles (between 22 and 35 days) * Two ovaries present * Planned for single or double day 3 transfer * Infertile couples scheduled for their first IVF/ICSI cycle with fixed antagonist protocol. * Informed consent obtained. Exclusion Criteria: * Women with contraindication for IVF or ICSI, such as poorly controlled type 1 or type 2 diabetes mellitus; undiagnosed liver disease or dysfunction (based on serum liver enzyme test results); renal disease or abnormal serum renal function; significant anemia; history of deep venous thrombosis, pulmonary embolus or cerebrovascular accident; uncontrolled hypertension or known symptomatic heart disease; history of (or suspected) cervical carcinoma, endometrial carcinoma or breast carcinoma; and undiagnosed vaginal bleeding. * Previous history of poor ovarian response (\<4 oocytes retrieved) with a maximal dose of OS (≥300 IU/day) or OHSS, regardless of gonadotropin dose * Known reasons for impaired implantation (i.e. hydrosalpinx, fibroid distorting the endometrial cavity, Asherman's syndrome, thrombophilia or endometrial tuberculosis) * Repeated miscarriages (\>2 previous biochemical pregnancies or \>2 spontaneous miscarriages) * Recurrent implantation failure (\>3 failed cycles with good quality embryos) * PCOS * Untreated thyroid disfunction * Administration of exogenous E2, P4 or gonadotropins in the preceding menstrual cycle * Active female smoking * Ongoing pregnancy * Women who have previously enrolled in the trial * Those unable to comprehend the investigational nature of the proposed study * either male partner or female partner has to receive donor sperm or donor eggs. * Either male partner or female partner has to receive PGD and PGS.
Contact & Investigator
Li
STUDY CHAIR
Peking University Third Hospital
Frequently Asked Questions
Who can join the NCT04163133 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 42 Years, studying IVF Outcome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04163133 currently recruiting?
Yes, NCT04163133 is actively recruiting participants. Contact the research team at roseli001@sina.com for enrollment information.
Where is the NCT04163133 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT04163133 clinical trial?
NCT04163133 is sponsored by Peking University Third Hospital. The principal investigator is Li at Peking University Third Hospital. The trial plans to enroll 834 participants.