Trigger Timing in Ovarian Stimulations

NCT04163133 | Recruiting DMC

• 1 other identifier: M2019261
• Study Type: interventional
• Target: 834
• Locations: 1 country
• Sites: 1

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.

Conditions

IVF Outcome

Keywords

delay of trigger, ovarian stimulation, antagonist protocol

Outcome Measures

Primary Outcomes (1)

• number of high-quality embryos

  Whether delaying the trigger for 1～2 days will get more high-quality embryos than conventional trigger

  4 weeks

Secondary Outcomes (1)

• Cumulative live birth rate

  24 months

Study Arms (2)

1～2 days delay of trigger group

EXPERIMENTAL

1～2 days later of trigger than regular trigger timing day (three follicles reach 17mm) .

Procedure: 1～2 days later trigger than regular timing

regular trigger group

NO INTERVENTION

regular trigger timing when three follicles reach 17mm bilateral.

Interventions

1～2 days later trigger than regular timing PROCEDURE

During ovarian stimulation, 1～2 days later of trigger after three follicles reach 17mm bilateral with contineous using of Gonadotrophin in antagonist protocol.

1～2 days delay of trigger group

Eligibility Criteria

• Age: 18 Years - 42 Years
• Gender Eligibility Details: Infertile female could be enrolled.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking Univesity Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Study Officials

• Li

  Peking University Third Hospital

  STUDY CHAIR

Central Study Contacts

Rong Li, M.D.

CONTACT

+86-010-82265080; roseli001@sina.com

Lin Zeng, PhD

CONTACT

13810002416; zlwhy@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Reproductive Medical Center

Model Details: A single center, open-label, randomized controlled clinical trial (1:1 treatment ratio). On the day of regular trigger timing day (three follicles reach 17mm) or 1～2 days later. 36(±2) hours after trigger, oocyte retrieval will be applying in both group with same protocol.

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 14, 2019
• Study Start: April 1, 2020
• Primary Completion: March 31, 2026
• Study Completion (Estimated): March 31, 2028
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)