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InfertilityCLBR-CBSETNCT03152643

Cumulative Live Birth Rates After Cleavage-stage Versus Blastocyst-stage Embryo Transfer

A study testing blastocyst-stage embryo transfer and cleavage-stage embryo transfer in people with Infertility, run by The First Affiliated Hospital with Nanjing Medical University at 11 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this RCT is to compare differences in the efficacy and safety between cleavage-stage embryo transfer and blastocyst-stage embryo transfer in IVF/ICSI treatment cycle, taking into account of subsequent vitrified embryo transfers. Read more about this study

Who is it for?
Ages 20 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Infertility
What is being tested?
blastocyst-stage embryo transfer and cleavage-stage embryo transfer
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
992 participants
Where
11 sitesChina
Study dates
29 Sep 2018to 18 Feb 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Women aged ≥20 and ≤40 years.
  • Women with the number of transferrable cleavage embryos ≥ 3;
  • Women undergoing their first or second cycle of IVF or ICSI.

Who cannot join

  • Women who have been diagnosed with uterine abnormalities (confirmed by three-dimensional ultrasonography or hysteroscopy), including malformed uterus (uterus unicornis, septate uterus or duplex uterus), submucous myoma, or intrauterine adhesion
  • Women who plan to undergo In Vitro Maturation (IVM);
  • Women who plan to undergo Preimplantation Genetic Diagnosis (PGD) /Preimplantation Genetic Screening (PGS).
  • Women who have Women who have hydrosalpinx visible on ultrasound.
  • Women who have experienced recurrent spontaneous abortions, defined as 2 or more previous pregnancy losses.
  • Women who have been developed a "freeze-all" treatment plan for purpose of subsequent surgery, such as salpingectomy due to hydrosalpinx after oocytes retrieval.
  • Women with contraindications to assisted reproductive technology and/or pregnancy, such as uncontrolled hypertension, symptomatic heart diseases, uncontrolled diabetes, undiagnosed liver disease or dysfunction (based on serum liver enzyme test results), undiagnosed renal disease or abnormal renal function, severe anemia, history of deep venous thrombosis, pulmonary embolus or cerebrovascular accident, history of or suspicious for cancer, undiagnosed vaginal bleeding.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

China11 sites

  • The Third Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

  • Center for Reproductive Medicine, Shandong Provincial Hospital Affiliated to Shandong University

    Jinan, Shandong

  • Clinical Center of Reproductive Medicine at the First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210000

  • Guangxi Maternal and Child Health Hospital

    Nanning, Guangxi

  • Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality

  • Shengjing Hospital of China Medical University

    Shenyang, Dongbei

  • Suzhou Municipal Hospital

    Suzhou, Suzhou

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia

  • Henan Provincial People's Hospital

    Zhengzhou, Henan

  • The Third Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

Other trials in China

About this study

Official title: Cumulative Live Birth Rates After Cleavage-stage Versus Blastocyst-stage Embryo Transfer: A Multicenter, Prospective, Randomized Controlled Trial

The aim of this RCT is to compare differences in the efficacy and safety between cleavage-stage embryo transfer and blastocyst-stage embryo transfer in IVF/ICSI treatment cycle, taking into account of subsequent vitrified embryo transfers. Subjects with 3 or more transferrable cleavage embryos will be randomized to the cleavage-stage or blastocyst-stage embryos transfer group. The primary outcome is cumulative live birth rate (CLBR) per patient until the first live birth from one initiated oocyte retrieval cycle, calculated using outcomes from the first three embryo transfers within 1 year after randomization.

Read the detailed description

This is a multicenter, randomized clinical trial comparing the efficacy and safety between cleavage-stage embryo transfer and blastocyst-stage embryo transfer in IVF/ICSI treatment cycle, taking into account of subsequent vitrified embryo transfers.Randomization will be performed on day 2/3 after oocyte retrieval, when at least 3 embryos are achieved. Patients in group A will have 1 cleavage-stage embryo transferred. Patients in group B will have 1 blastocyst-stage embryo transferred. The outcomes from all the embryo transfers within 1 year after randomization will be followed up. If a pregnancy/live birth is not achieved, single embryo transfer is required for the first 3 embryo transfers within 1 year after randomization. For embryo transfers beyond the third within the 1 year, patient's treatment must follow their randomized allocation, and SET is no longer mandatory. The follow-up period is 2 years from the day of randomization.Due to the COVID-19 pandemic, the participants who were unable to undergo the embryo transfers in 1 year of randomization will have 3 months extension for frozen embryo transfer. The follow-up for these participants will be extended for 3 months as well.

Conditions
Infertility
Being tested
blastocyst-stage embryo transfer, cleavage-stage embryo transfer
Keywords
Cumulative live birth rates, cleavage-stage embryo transfer, blastocyst transfer
Medical subject headings
Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • blastocyst-stage embryo transferProcedure or surgery

    All the participants will receive a long GnRH-agonist, ultra-long GnRH-agonist, short GnRH-agonist or GnRH antagonist protocol in combination with recombinant FSH. HCG will be administered for final oocyte maturation. Patients will have a single blastocyst-stage embryos transferred. The outcomes of all the embryo transfers within 1 year after randomization will be followed up. Single embryo transfer (SET) is required for the first 3 embryo transfers within 1 year after randomization. For embryo transfers beyond the third within the 1 year, patients' treatment must follow their randomized allocation, and SET is no longer mandatory. Luteal phase support will be administered before embryo transfer. If pregnancy is confirmed, luteal phase support will be continued until 10 weeks of gestation. The follow up will be continued until 6 weeks after delivery.

  • cleavage-stage embryo transferProcedure or surgery

    All the participants will receive a long GnRH-agonist, ultra-long GnRH-agonist, short GnRH-agonist or GnRH antagonist protocol in combination with recombinant FSH. HCG will be administered for final oocyte maturation. Patients will have a single cleavage-stage embryos transferred. The outcomes of all the embryo transfers within 1 year after randomization will be followed up. Single embryo transfer (SET) is required for the first 3 embryo transfers within 1 year after randomization. For embryo transfers beyond the third within the 1 year, patients' treatment must follow their randomized allocation, and SET is no longer mandatory. Luteal phase support will be administered before embryo transfer. If pregnancy is confirmed, luteal phase support will be continued until 10 weeks of gestation. The follow up will be continued until 6 weeks after delivery.

Study groups in NCT03152643
Study groupRoleWhat they receive
blastocyst-stage embryo transfer groupExperimentalFor subjects assigned to blastocyst-stage (D5/D6) embryo transfer group, all embryos will be cultured to D5 or D6. 1 blastocysts of the best quality will be transferred in fresh cycle on D5 or D6 after oocyte retrieval (D5 embryo will be the prior choice). The surplus embryos, if any, will be vitrified for future FET in case the fresh cycle does not result in a live birth. If a patient is at a high risk of OHSS, all embryos on D5 or D6 can be cryopreserved with vitrification for patient's safety. The FET cycle will be initiated on the second menstrual cycle after oocyte retrieval.
Receives: Procedure: blastocyst-stage embryo transfer
cleavage-stage embryo transfer groupExperimentalFor subjects assigned to the cleavage-stage (D2/3) embryo transfer group, 1 cleavage embryos of the best quality will be transferred in fresh cycle on Day 2/3 after oocyte retrieval. The surplus embryos, if any, will be vitrified for future FET if the fresh cycle does not result in a live birth. If a patient is at a high risk of OHSS, all embryos on Day 2/3 are allowed to be cryopreserved with vitrification for patient's safety. The FET cycle will be initiated on the second menstrual cycle after oocyte retrieval.
Receives: Procedure: cleavage-stage embryo transfer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. cumulative live birth rate

    Cumulative live birth rate (CLBR) is defined the first live birth per patient from one initiated oocyte retrieval cycle(Calculated using outcomes from the first three embryo transfers within 1 year after randomization). Live birth is defined as delivery of any neonate ≥24 weeks gestation with heart beat and breath.

    Measured: 30 months

Secondary outcomes (12)

  1. biochemical pregnancy rate

    Biochemical pregnancy is defined as a serum β-HCG level of at least 25 IU/L 14 days after embryo transfer.

    Measured: 30 months

  2. clinical pregnancy rate

    Clinical pregnancy is defined by the presence of intrauterine gestation sacs at 30-35 days after embryo transfer.

    Measured: 30 months

  3. ongoing pregnancy rate

    Ongoing pregnancy is defined as a viable pregnancy at 12 weeks gestation.

    Measured: 30 months

  4. Pregnancy loss rate

    Pregnancy loss is defined as a pregnancy that results in a spontaneous abortion or therapeutic abortion that occurred throughout pregnancy.

    Measured: 30 months

  5. moderate or severe OHSS rate

    Number of patients with moderate or severe OHSS/ number of COS cycles.

    Measured: 12 months

  6. ectopic pregnancy

    diagnosed by ultrasound examination or laparoscopic surgery visualizing more than or equal to 1 gestational sacs outside the uterus or by abnormally increasing serum hCG level without sonographic visualization and the absence of chorionic villi inside the uterus after uterine curettage, which was treated by methotrexate.

    Measured: 24 months

  7. sex ratio

    the ratio of males to females in the newborns

    Measured: 30 months

  8. multiple pregnancy

    Number of multiple pregnancies / number of clinical pregnancies.

    Measured: 30 months

  9. incidence of obstetric and perinatal complications

    Number of pregnancies with complications / number of pregnancies; ;number of live births with neonatal complications / number of live births

    Measured: 30 months

  10. congenital anomalies

    structural or functional anomalies that occur during intrauterine life and can be identified prenatally, at birth or later in life.

    Measured: 30 months

  11. implantation rate

    the number of gestational sacs detected with sonography at 6 weeks of pregnancy/the number of embryos transferred

    Measured: 30 months

  12. Birth weight

    Weight of newborns at delivery

    Measured: 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2017
  2. Study start29 Sep 2018
  3. Primary completion6 Sep 2021
  4. Study completion18 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
992 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03152643
Sponsor's protocol ID
CLBR-CBSET
Acronym
CLBR-CBSET
Status last verified
Jun 2022
First submitted
9 May 2017
Last updated
9 Jun 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ma X, Wang J, Shi Y, Tan J, Guan Y, Sun Y, Zhang B, Zhao J, Liu J, Cao Y, Li H, Zhang C, Chen F, Yi H, Wang Z, Xin X, Kong P, Lu Y, Huang L, Yuan Y, Liu H, Li C, Mol BWJ, Hu Z, Zhang H, Chen ZJ, Liu J. Effect of single blastocyst-stage versus single cleavage-stage embryo transfer on cumulative live births in women with good prognosis undergoing in vitro fertilization: Multicenter Randomized Controlled Trial. Nat Commun. 2024 Sep 5;15(1):7747. doi: 10.1038/s41467-024-52008-y.

    PubMed 39237545

Questions about this trial

What is this clinical trial studying?

A study testing blastocyst-stage embryo transfer and cleavage-stage embryo transfer in people with Infertility, run by The First Affiliated Hospital with Nanjing Medical University at 11 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

cumulative live birth rate (time frame: 30 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03152643, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2022.

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