RecruitingNot ApplicableNCT04163133

Trigger Timing in Ovarian Stimulations

Comparison of Regular Trigger Timing and 1~2 Days Delay of Trigger in Ovarian Stimulations by GnRH Antagonist Protocol in in Vitro Fertilization


Sponsor

Peking University Third Hospital

Enrollment

834 participants

Start Date

Apr 1, 2020

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 42 Years

Inclusion Criteria10

  • 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 Criteria14

  • 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.

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Interventions

PROCEDURE1~2 days later trigger than regular timing

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


Locations(1)

Peking Univesity Third Hospital

Beijing, Beijing Municipality, China

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NCT04163133


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