SubfertilityNCT02570386
Clinical Effectiveness of Frozen Thawed Embryo Transfer Compared to Fresh Embryo Transfer
A study testing Fresh embryo transfer and Frozen embryo transfer in people with Subfertility, run by The University of Hong Kong at 1 site in China.
Trial summary
The objective of the present randomized controlled study is to compare clinical effectiveness and safety of freezing all embryos followed by frozen-thawed embryo transfer (FET) compared to fresh embryo transfer, in women undergoing IVF treatment. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Subfertility
- What is being tested?
- Fresh embryo transfer and Frozen embryo transfer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteChina
- Study dates
- Oct 2015to Dec 2018
- 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 18 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women under 42 years of age
- Presence of at least 3 embryos suitable to freeze on day 2 or 3 following fertilisation based on the centre's criteria
- Written informed consent
Who cannot join
- Women using donor eggs/donor sperm
- Women undergoing preimplantation genetic diagnosis
- Women with abnormal uterine cavity shown on hysterosalpingogram or saline infusion sonogram
- Women with hydrosalpinges shown on scanning and not corrected treated
- Women with excessive ovarian response at risk of ovarian hyperstimulation where elective freeze is already planned
- Women with serum progesterone level on day of human chorionic gonadotrophin>1.5ng/ml or 5 nmol/L
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- Women whose embryos have not survived freeze-thawing in the past
- Fresh transfer is planned e.g. patients with endometriosis or adenomyosis who have received prolonged downregulation
- Only frozen transfer is planned e.g. patients receiving ovarian stimulation regimens which may have adverse impacts on the endometrium
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Clinical Effectiveness of Freezing All Embryos Followed by Frozen Thawed Embryo Transfer Compared to Fresh Embryo Transfer, in Women Undergoing In-vitro Fertilization Treatment
The objective of the present randomized controlled study is to compare clinical effectiveness and safety of freezing all embryos followed by frozen-thawed embryo transfer (FET) compared to fresh embryo transfer, in women undergoing IVF treatment.
Read the detailed description
A total of 800 infertile women undergoing IVF treatment will be randomized into one of the following two groups by computer-generated random numbers:
Fresh embryo transfer group: a single fresh embryo transfer FET group: a single FET following freezing of all embryos in the stimulated IVF cycle
All techniques of IVF including ovarian stimulation, harvesting of oocytes, insemination with specially prepared sperm and embryo culture in the laboratory will be according to local protocols. Once the embryos have been cultured up to day 2 or 3, women with 3 or more suitable quality embryos will be randomized to either fresh embryo transfer (control arm) or FET (Intervention arm).
Control arm Women allocated to the control arm will either undergo embryo transfer at cleavage stage or extended culture and transfer at blastocyst stage according to local policy. A maximum of 2 embryos or blastocysts will be replaced according to the standard protocol under transabdominal ultrasound guidance. Luteal phase support is given according to local protocols.
Intervention arm For those allocated to the intervention arm fresh embryo transfer will not be undertaken. Embryos will be frozen by vitrification or slow freezing at cleavage or blastocyst stage according to standard agreed local protocols. Women will be contacted after 4 weeks and arrangements made for frozen embryo transfer.
After at least 4 weeks women will attend the IVF clinic for the transfer of thawed frozen embryos, either in a natural cycle (in ovulatory women who have regular menstrual cycles) or in a hormonally supported cycle using physiological doses of estrogen and progestogens to mimic normal cyclical changes within the endometrium. The choice between replacing frozen-thawed embryos in a natural or hormonally mediated cycle will be a decision driven by the clinical circumstances.
Embryos or blastocysts will be thawed according to local protocols. The transfer is performed by the team clinician with a maximum of 2 embryos or blastocysts being replaced according to the standard protocol under transabdominal ultrasound guidance. Luteal phase support is given at the discretion of the physician.
Follow up strategy:
A pregnancy test will be carried out 2 weeks after embryo transfer in both arms. All women who have a positive pregnancy test 2 weeks after embryo transfer will undergo a transvaginal ultrasound scan to identify the presence and number of a gestation sac with a fetal heart signifying an ongoing pregnancy. Pelvic scan will be repeated at 8 weeks, 12 weeks, 24 weeks and 36 gestation for fetal growth.
Data on all pregnancy outcomes including early pregnancy losses such as miscarriage or ectopic pregnancy will be collected.
In order to achieve consistency with respect to the collection of outcome, standardised case report forms (CRF) will be completed for each woman at each centre. These CRFs will include details on treatment received, pregnancy outcomes, complications in pregnancy, mode of delivery and birth outcomes.
- Conditions
- Subfertility
- Being tested
- Fresh embryo transfer, Frozen embryo transfer
- Keywords
- In-vitro fertilization, frozen thawed embryo transfer, fresh embryo transfer
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresh embryo transferProcedure or surgery
Women allocated to the control arm will either undergo embryo transfer at cleavage stage or extended culture and transfer at blastocyst stage according to local policy. A maximum of 2 embryos or blastocysts will be replaced according to the standard protocol under transabdominal ultrasound guidance. Luteal phase support is given according to local protocols.
Frozen embryo transferProcedure or surgery
Fresh embryo transfer will not be undertaken. Embryos will be frozen by vitrification or slow freezing at cleavage or blastocyst stage according to standard agreed local protocols. Women will be contacted after 4 weeks and arrangements made for frozen embryo transfer.
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Active comparator | Women allocated to the control arm will either undergo fresh embryo transfer at cleavage stage or extended culture and transfer at blastocyst stage according to local policy. A maximum of 2 embryos or blastocysts will be replaced according to the standard protocol under transabdominal ultrasound guidance. Luteal phase support is given according to local protocols. Receives: Procedure: Fresh embryo transfer |
| Intervention arm | Active comparator | Fresh embryo transfer will not be undertaken in this group. Embryos will be frozen by vitrification or slow freezing at cleavage or blastocyst stage according to standard agreed local protocols. Women will be contacted after 4 weeks and arrangements made for frozen embryo transfer. Receives: Procedure: Frozen embryo transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate
A baby born alive after 20 weeks gestation
Measured: up to 24 weeks
Secondary outcomes (6)
Miscarriage rate
Miscarriage before 20 weeks gestation
Measured: up to 24 weeks
Clinical pregnancy rates
Presence of at least one gestational sac on ultrasound at 6 weeks
Measured: up to 24 weeks
Ovarian hyperstimulation rate
Ovarian hyperstimulation rate classified according to Royal College of Obstetrics and Gynaecology in the United Kingdom
Measured: about 1 month
Failure of embryos to survive after thawing (per embryo thawed)
More than 50% of cells lysed on thawing
Measured: around 6 months
Cumulative live birth within 6 months of ovarian stimulation
Live birth from the fresh and frozen thawed embryo transfer
Measured: up to 24 weeks
Complications of pregnancy
Complications of pregnancy
Measured: around 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2018
- Study completionDec 2018
Why it stopped: very slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SubfertilityStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Third Hospital, Nanfang Hospital, Southern Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Responsible party
- Sponsor
- Investigators
- Ernest HY Ng, MD, Principal investigator, Department of Obstetrics and Gynaecology, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02570386
- Sponsor's protocol ID
- UW 15-001
- Status last verified
- Apr 2019
- First submitted
- 29 Sep 2015
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zaat T, Zagers M, Mol F, Goddijn M, van Wely M, Mastenbroek S. Fresh versus frozen embryo transfers in assisted reproduction. Cochrane Database Syst Rev. 2021 Feb 4;2(2):CD011184. doi: 10.1002/14651858.CD011184.pub3.
PubMed 33539543
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Clinical Effectiveness of Freezing All Embryos Followed by Frozen Thawed Embryo Transfer Compared to Fresh Embryo Transfer, in Women Undergoing In-vitro Fertilization Treatment
- ClinicalTrials.gov ID
- NCT02570386
- Acronym / sponsor ID
- UW 15-001
- Conditions
- Subfertility
- Keywords
- In-vitro fertilization, frozen thawed embryo transfer, fresh embryo transfer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: very slow recruitment
- Enrolment
- 138 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Peking University Third Hospital, Nanfang Hospital, Southern Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Study start
- Oct 2015
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 7 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the present randomized controlled study is to compare clinical effectiveness and safety of freezing all embryos followed by frozen-thawed embryo transfer (FET) compared to fresh embryo transfer, in women undergoing IVF treatment.
Detailed description
A total of 800 infertile women undergoing IVF treatment will be randomized into one of the following two groups by computer-generated random numbers:
Fresh embryo transfer group: a single fresh embryo transfer FET group: a single FET following freezing of all embryos in the stimulated IVF cycle
All techniques of IVF including ovarian stimulation, harvesting of oocytes, insemination with specially prepared sperm and embryo culture in the laboratory will be according to local protocols. Once the embryos have been cultured up to day 2 or 3, women with 3 or more suitable quality embryos will be randomized to either fresh embryo transfer (control arm) or FET (Intervention arm).
Control arm Women allocated to the control arm will either undergo embryo transfer at cleavage stage or extended culture and transfer at blastocyst stage according to local policy. A maximum of 2 embryos or blastocysts will be replaced according to the standard protocol under transabdominal ultrasound guidance. Luteal phase support is given according to local protocols.
Intervention arm For those allocated to the intervention arm fresh embryo transfer will not be undertaken. Embryos will be frozen by vitrification or slow freezing at cleavage or blastocyst stage according to standard agreed local protocols. Women will be contacted after 4 weeks and arrangements made for frozen embryo transfer.
After at least 4 weeks women will attend the IVF clinic for the transfer of thawed frozen embryos, either in a natural cycle (in ovulatory women who have regular menstrual cycles) or in a hormonally supported cycle using physiological doses of estrogen and progestogens to mimic normal cyclical changes within the endometrium. The choice between replacing frozen-thawed embryos in a natural or hormonally mediated cycle will be a decision driven by the clinical circumstances.
Embryos or blastocysts will be thawed according to local protocols. The transfer is performed by the team clinician with a maximum of 2 embryos or blastocysts being replaced according to the standard protocol under transabdominal ultrasound guidance. Luteal phase support is given at the discretion of the physician.
Follow up strategy:
A pregnancy test will be carried out 2 weeks after embryo transfer in both arms. All women who have a positive pregnancy test 2 weeks after embryo transfer will undergo a transvaginal ultrasound scan to identify the presence and number of a gestation sac with a fetal heart signifying an ongoing pregnancy. Pelvic scan will be repeated at 8 weeks, 12 weeks, 24 weeks and 36 gestation for fetal growth.
Data on all pregnancy outcomes including early pregnancy losses such as miscarriage or ectopic pregnancy will be collected.
In order to achieve consistency with respect to the collection of outcome, standardised case report forms (CRF) will be completed for each woman at each centre. These CRFs will include details on treatment received, pregnancy outcomes, complications in pregnancy, mode of delivery and birth outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | Active comparator | Procedure: Fresh embryo transferWomen allocated to the control arm will either undergo fresh embryo transfer at cleavage stage or extended culture and transfer at blastocyst stage according to local policy. A maximum of 2 embryos or blastocysts will be replaced according to the standard protocol under transabdominal ultrasound guidance. Luteal phase support is given according to local protocols. |
| Intervention arm | Active comparator | Procedure: Frozen embryo transferFresh embryo transfer will not be undertaken in this group. Embryos will be frozen by vitrification or slow freezing at cleavage or blastocyst stage according to standard agreed local protocols. Women will be contacted after 4 weeks and arrangements made for frozen embryo transfer. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women under 42 years of age
- Presence of at least 3 embryos suitable to freeze on day 2 or 3 following fertilisation based on the centre's criteria
- Written informed consent
Key exclusion criteria (9 listed)
- Women using donor eggs/donor sperm
- Women undergoing preimplantation genetic diagnosis
- Women with abnormal uterine cavity shown on hysterosalpingogram or saline infusion sonogram
- Women with hydrosalpinges shown on scanning and not corrected treated
- Women with excessive ovarian response at risk of ovarian hyperstimulation where elective freeze is already planned
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fresh embryo transferWomen allocated to the control arm will either undergo embryo transfer at cleavage stage or extended culture and transfer at blastocyst stage according to local policy. A maximum of 2 embryos or blastocysts will be replaced according to the standard protocol under transabdominal ultrasound guidance. Luteal phase support is given according to local protocols. | Procedure or surgery | Control arm |
| Frozen embryo transferFresh embryo transfer will not be undertaken. Embryos will be frozen by vitrification or slow freezing at cleavage or blastocyst stage according to standard agreed local protocols. Women will be contacted after 4 weeks and arrangements made for frozen embryo transfer. | Procedure or surgery | Intervention arm |
Primary outcome
Live birth rate
Time frame: up to 24 weeks
A baby born alive after 20 weeks gestation
6 secondary outcomes
Miscarriage rate
Time frame: up to 24 weeks
Clinical pregnancy rates
Time frame: up to 24 weeks
Ovarian hyperstimulation rate
Time frame: about 1 month
Failure of embryos to survive after thawing (per embryo thawed)
Time frame: around 6 months
Cumulative live birth within 6 months of ovarian stimulation
Time frame: up to 24 weeks
Complications of pregnancy
Time frame: around 1 years
Results and safety
The study was stopped early (reason given: very slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Derived from this study: PubMed 33539543Zaat T, Zagers M, Mol F, Goddijn M, van Wely M, Mastenbroek S. Fresh versus frozen embryo transfers in assisted reproduction. Cochrane Database Syst Rev. 2021 Feb 4;2(2):CD011184. doi: 10.1002/14651858.CD011184.pub3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ernest HY Ng, MD principal investigator
Department of Obstetrics and Gynaecology, The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fresh embryo transfer and Frozen embryo transfer in people with Subfertility, run by The University of Hong Kong at 1 site 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 9 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: stopped early, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: very slow recruitment). Results are not available in the source record.
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?
Live birth rate (time frame: up to 24 weeks). 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 NCT02570386, 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 18 Apr 2019.