- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05483270
Immediate Versus Postponed Freeze-all Embryo Transfer in Hyperresponders
Immediate Versus Postponed Freeze-all Embryo Transfer in Hyperresponders, A Multicenter Randomised Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
It is postulated that postponing embryo transfer for at least one menstrual cycle after a freeze-all cycle can minimise the possible residual negative effect caused by ovarian stimulation and can promote the resumption of a normal ovulatory cycle and the receptivity of endometrium. Nevertheless, emerging evidence suggests a higher live birth rate in the immediate freeze-all embryo transfer (FET) cycles compared to that in the delayed group. It is unclear the whether postponed FET is superior in hyperresponders. The investigators hypothesize the success rate in the postponed FET for at least one menstrual cycle after oocyte retrieval is higher than in the immediate FET in hyperresponders.
Objective: To evaluate whether the postponed FET for at least one menstrual cycle after oocyte retrieval is superior to the immediate FET in the first menstrual cycle after oocyte retrieval in hyperresponders in terms of live birth rates.
Design: a multicenter, randomised controlled trial Patients: The investigators plan to randomise participants to the immediate FET and the postponed FET from the day of oocyte retrieval to the last day of that menstrual cycle.
Primary outcome: live birth rate after the embryo transfer. Patients who get pregnant will be followed up until 6 weeks after delivery.
Sample size: The investigators plan to enroll 836 participants in a 1:1 rate.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kai-Lun Hu, M.D
- Phone Number: 15901575271
- Email: hukailun@bjmu.edu.cn
Study Locations
-
-
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Beijing, China, 100191
- Recruiting
- Peking University Third Hospital
-
Contact:
- Rong Li, MD,PHD
- Phone Number: 13701085402
- Email: roseli001@sina.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Women aged 20 to 42 years old;
- Written informed consent;
- Women scheduled for freeze-all embryo transfer;
- Women with the number of oocyte collected higher than 15.
Exclusion Criteria:
- Women with a history of at lease three failed transfer cycles;
- Women with an endometrial thickness less than 7 mm on the triggering day;
- Severe uterine malformations.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Immediate FET group
Freeze-all embryo transfer will be carried out in the menstrual cycle immediately following oocyte retrieval.
|
Immediate FET group Freeze-all embryo transfer will be carried out in the menstrual cycle immediately following oocyte retrieval. Postponed FET group Freeze-all embryo transfer will be carried out during the second menstrual cycle to 6 months after oocyte retrieval. |
Experimental: Postponed FET group
Freeze-all embryo transfer will be carried out during the second menstrual cycle to 6 months after oocyte retrieval.
|
Immediate FET group Freeze-all embryo transfer will be carried out in the menstrual cycle immediately following oocyte retrieval. Postponed FET group Freeze-all embryo transfer will be carried out during the second menstrual cycle to 6 months after oocyte retrieval. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Live birth after the first embryo transfer
Time Frame: At least 22 months gestation after the first embryo transfer cycle
|
Live birth is defined as the delivery of at least one baby after 22 weeks of gestation that exhibits any sign of life.
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At least 22 months gestation after the first embryo transfer cycle
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical pregnancy
Time Frame: around 7 weeks' gestation after the first embryo transfer cycle
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defined as at least one gestational sac on ultrasound at around 7 weeks' gestation with the detection of heart-beat activity
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around 7 weeks' gestation after the first embryo transfer cycle
|
Ongoing pregnancy
Time Frame: 12 weeks' gestation or beyond after the first embryo transfer cycle
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defined as pregnancy with detectable heart rate at 12 weeks' gestation or beyond
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12 weeks' gestation or beyond after the first embryo transfer cycle
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Biochemical pregnancy
Time Frame: about 12 days after embryo transfer
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defined as a positive pregnancy test
|
about 12 days after embryo transfer
|
Ectopic pregnancy
Time Frame: about 6 weeks after embryo transfer
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defined as embryo implanted at any site other than the endometrial lining of the uterus cavity
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about 6 weeks after embryo transfer
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Pre-eclampsia
Time Frame: after 20 weeks of gestation
|
defined as the development of gestational hypertension with proteinuria (≥300 mg/24-hour urine collection or 30 mg/dL in single urine sample) of new onset after 20 weeks of gestation
|
after 20 weeks of gestation
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Premature rupture of membrane (PROM) rate
Time Frame: the day of delivery
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defined as rupture of the amniotic membranes before the onset of labor including PROM at term and preterm PROM
|
the day of delivery
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Preterm delivery
Time Frame: less than 37 and more than 21 weeks' gestational age
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defined as delivery of a fetus at less than 37 weeks' gestational age
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less than 37 and more than 21 weeks' gestational age
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Placenta previa
Time Frame: the day of delivery
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defined as a placenta that is implanted over or very close to the internal cervical orifice
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the day of delivery
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Postpartum hemorrhage
Time Frame: the day of delivery
|
defined as the loss of 500 ml of blood or more after completion of the third stage of labor
|
the day of delivery
|
Birth weight
Time Frame: the day of delivery
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Birth weight
|
the day of delivery
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Stillbirth
Time Frame: the day of delivery
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defined as the absence of signs of life at or after birth
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the day of delivery
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Miscarriage
Time Frame: 6-22 weeks of gestation
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defined as spontaneous loss of a clinical pregnancy before 22 completed weeks of gestational age, in which the embryo(s) or fetus(es) is/are nonviable or is/are absorbed or expelled from the uterus.
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6-22 weeks of gestation
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Cumulative live birth
Time Frame: 6 month after the first embryo transfer
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the cumulative rate of live born children conceived within six months of the first FET cycle.
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6 month after the first embryo transfer
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Gestational hypertension
Time Frame: after 20 weeks of gestation
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defined as the development of blood pressure greater than 140/90 mmHg after pregnancy without proteinuria or other signs of preeclampsia
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after 20 weeks of gestation
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Gestational diabetes mellitus
Time Frame: after 24 weeks of gestation
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defined as carbohydrate intolerance of variable severity with onset or first recognition during pregnancy as determined from the diagnosis in the obstetrical medical record
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after 24 weeks of gestation
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Mode of delivery
Time Frame: the day of delivery
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Vaginal birth or Caesarean Section
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the day of delivery
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kai-Lun Hu, M.D, Peking University Third Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Delay-ET-RCT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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