| 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 | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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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 2027-03-31.
⚠ 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 gonadotrophin-releasing hormone (GnRH) antagonist protocol is widely used in in vitro fertilisation (IVF) for its flexibility and ability to reduce the risk of ovarian hyperstimulation syndrome (OHSS). Conventionally, the trigger criterion is set at ≥3 follicles ≥17 mm. Whether this criterion is premature and whether a 1-2 day delay could improve the number of good-quality embryos and cumulative live birth rate, requires prospective evaluation. While delaying the trigger could theoretically allow for more complete follicular maturation and improve oocyte yield, existing evidence is contradictory; some studies report increased oocyte numbers without a corresponding improvement in live birth rates, potentially due to adverse endometrial changes. Therefore, this randomised controlled trial (RCT) aims to determine whether a one- to two-day delay in triggering ovulation, compared to the conventional criterion, increases the number of good-quality embryos and improves cumulative live birth rates in women undergoing IVF or intracytoplasmic sperm injection (ICSI).
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/m2 * 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 or second IVF/ICSI cycle using a 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 * Women who must receive donor eggs. * Preimplantation genetic testing (PGT) cycle.
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.