Trigger Timing in Ovarian Stimulations (NCT04163133) | Clinical Trial Compass
RecruitingNot Applicable
Trigger Timing in Ovarian Stimulations
China834 participantsStarted 2020-04-01
Plain-language 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.
Who can participate
Age range
18 Years – 42 Years
Sex
FEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Administr…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.