SubfertilityNCT02197832
A RCT on the Effect of Endometrial Injury on Improving Ongoing Pregnancy Rate in Subfertile Women Undergoing FET Cycles
A study testing Endometrial biopsy and Pipelle catheter (Pipelle de Cornier, Laboratoire C.C.D., France) in people with Subfertility, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This is a randomised controlled trial on the effect of endometrial injury in the cycle preceding the frozen-thawed embryo transfer (FET) cycles. The study hypothesis is that endometrial injury will increase the ongoing pregnancy rate in FET cycles. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Subfertility
- What is being tested?
- Endometrial biopsy and Pipelle catheter (Pipelle de Cornier, Laboratoire C.C.D., France)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteHong Kong
- Study dates
- Sep 2012to Mar 2015
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Undergoing FET treatment cycles
- Normal uterine cavity as shown on transvaginal scanning or saline sonogram done at baseline
- endometrial thickness >=8mm during the stimulated IVF cycle and FET cycle
Who cannot join
- Pregnancy in previous IVF or FET cycles
- Presence of hydrosalpinx not surgically corrected prior to FET
- Presence of endometrial polyp or fibroid distorting uterine cavity
- IVF cycles carried out for preimplantation genetic diagnosis
- Arrange for blastocyst transfer
- Use of donor oocytes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial on the Effect of Endometrial Injury on Improving Ongoing Pregnancy Rate in Subfertile Women Undergoing Frozen-thawed Embryo Transfer Treatment Cycles
This is a randomised controlled trial on the effect of endometrial injury in the cycle preceding the frozen-thawed embryo transfer (FET) cycles. The study hypothesis is that endometrial injury will increase the ongoing pregnancy rate in FET cycles.
Read the detailed description
Consecutive women attending subfertility clinic at Queen Mary Hospital, University of Hong Kong who are scheduled for FET treatment will be recruited. Women who have normal uterine cavity will be randomized into study and control groups in 1 to 1 ratio according to a computer-generated randomization list.
For patients in the study group, in the cycle immediately preceding the scheduled FET treatment, an endometrial biopsy would be arranged on day 21-23 of the menstrual cycles and they will be instructed to use non-hormonal means of contraception during that cycle. For patient in the control group, a similar procedure would be performed on the same timing during the preceding cycles without entering the uterine cavity, ie endometrial biopsy catheter entering the endocervical canal without entering the endometrial cavity. All patients will then proceed to FET treatment in the next cycle as scheduled.
The FET would be carried out as per our protocol. In short, patients attend the clinic daily from 18 days before the next expected period for the determination of serum E2 and luteinising hormone (LH) concentrations until the LH surge, which was defined as the day on which the LH level was above 20 IU/L and doubled the average of the LH levels over the past three days. For patients with irregular menstrual cycles or no ovulation demonstrated during natural cycle monitoring, clomiphene citrate (CC, Clomid, Merrell, Staines, U.K.) 50-100 mg will be given daily for five days from Days 3-7. The cycle will be monitored by blood tests from day 10 of the cycle as above. FET was performed on the third day after the LH surge. Up to two frozen-thawed embryo(s) can be transferred. No luteal phase support is used. On-going pregnancy rates, defined as viable fetuses beyond 10-12 gestational weeks, between the two groups will be compared.
We should measure endometrial thickness on LH+1 in natural and clomid-induced cycles.
- Conditions
- Subfertility
- Being tested
- Endometrial biopsy, control procedure, Pipelle catheter (Pipelle de Cornier, Laboratoire C.C.D., France)
- Keywords
- Frozen thawed embryo transfer, Endometrial injury, Ongoing pregnancy rates
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endometrial biopsyProcedure or surgery
The procedure was performed in a standard approach using a Pipelle catheter (Pipelle de Cornier, Laboratoire C.C.D., France). The pipelle catheter was introduced through the cervix up to the uterine fundus. The piston was drawn back to the end of the sheath to create a negative pressure. The sheath was rotated and moved back and forth between the fundus and internal os for at least 3-4 times before it was gently withdrawn.
control procedureProcedure or surgery
Using pipelle catheter without entering the uterine cavity.
Pipelle catheter (Pipelle de Cornier, Laboratoire C.C.D., France)Device
| Study group | Role | What they receive |
|---|---|---|
| EA | Experimental | in the cycle immediately preceding the scheduled FET treatment, an endometrial biopsy would be arranged on day 21-23 of the menstrual cycles and they will be instructed to use non-hormonal means of contraception during that cycle. Receives: Procedure: Endometrial biopsy |
| Control | Placebo comparator | The procedure was performed in a standard approach using a Pipelle catheter (Pipelle de Cornier, Laboratoire C.C.D., France). The pipelle catheter was introduced through the cervix but not into the uterine cavity, only entering the endocervical canal as control. Receives: Procedure: control procedure; Device: Pipelle catheter (Pipelle de Cornier, Laboratoire C.C.D., France) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate
Pregnancy at 10-12 weeks
Measured: pregnancy at 10-12 weeks
Secondary outcomes (2)
Implantation rate
Implantation rate = number of gestation sacs on ultrasound (USG) / number of embryos transferred
Measured: 4-6 weeks after embryo transfer
Clinical pregnancy rate
Clinical pregnancy rate is the presence of gestation sac on USG scan.
Measured: 6 weeks after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2014 (estimated)
- Study startSep 2012
- Primary completionMar 2015
- Study completionMar 2015
Why it stopped: Difficulty in recruiting participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vivian CY Lee, MBBS, Principal investigator, Queen Mary Hospital / University of Hong Kong.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02197832
- Sponsor's protocol ID
- HKU-VL-FETEA
- Status last verified
- Dec 2015
- First submitted
- 20 Jul 2014
- Last updated
- 11 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on the Effect of Endometrial Injury on Improving Ongoing Pregnancy Rate in Subfertile Women Undergoing Frozen-thawed Embryo Transfer Treatment Cycles
- ClinicalTrials.gov ID
- NCT02197832
- Acronym / sponsor ID
- HKU-VL-FETEA
- Conditions
- Subfertility
- Keywords
- Frozen thawed embryo transfer, Endometrial injury, Ongoing pregnancy rates
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in recruiting participants.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 23 Jul 2014 (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.
This is a randomised controlled trial on the effect of endometrial injury in the cycle preceding the frozen-thawed embryo transfer (FET) cycles. The study hypothesis is that endometrial injury will increase the ongoing pregnancy rate in FET cycles.
Detailed description
Consecutive women attending subfertility clinic at Queen Mary Hospital, University of Hong Kong who are scheduled for FET treatment will be recruited. Women who have normal uterine cavity will be randomized into study and control groups in 1 to 1 ratio according to a computer-generated randomization list.
For patients in the study group, in the cycle immediately preceding the scheduled FET treatment, an endometrial biopsy would be arranged on day 21-23 of the menstrual cycles and they will be instructed to use non-hormonal means of contraception during that cycle. For patient in the control group, a similar procedure would be performed on the same timing during the preceding cycles without entering the uterine cavity, ie endometrial biopsy catheter entering the endocervical canal without entering the endometrial cavity. All patients will then proceed to FET treatment in the next cycle as scheduled.
The FET would be carried out as per our protocol. In short, patients attend the clinic daily from 18 days before the next expected period for the determination of serum E2 and luteinising hormone (LH) concentrations until the LH surge, which was defined as the day on which the LH level was above 20 IU/L and doubled the average of the LH levels over the past three days. For patients with irregular menstrual cycles or no ovulation demonstrated during natural cycle monitoring, clomiphene citrate (CC, Clomid, Merrell, Staines, U.K.) 50-100 mg will be given daily for five days from Days 3-7. The cycle will be monitored by blood tests from day 10 of the cycle as above. FET was performed on the third day after the LH surge. Up to two frozen-thawed embryo(s) can be transferred. No luteal phase support is used. On-going pregnancy rates, defined as viable fetuses beyond 10-12 gestational weeks, between the two groups will be compared.
We should measure endometrial thickness on LH+1 in natural and clomid-induced cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EA | Experimental | Procedure: Endometrial biopsyin the cycle immediately preceding the scheduled FET treatment, an endometrial biopsy would be arranged on day 21-23 of the menstrual cycles and they will be instructed to use non-hormonal means of contraception during that cycle. |
| Control | Placebo comparator | Procedure: control procedure, Device: Pipelle catheter (Pipelle de Cornier, Laboratoire C.C.D., France)The procedure was performed in a standard approach using a Pipelle catheter (Pipelle de Cornier, Laboratoire C.C.D., France). The pipelle catheter was introduced through the cervix but not into the uterine cavity, only entering the endocervical canal as control. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Undergoing FET treatment cycles
- Normal uterine cavity as shown on transvaginal scanning or saline sonogram done at baseline
- endometrial thickness >=8mm during the stimulated IVF cycle and FET cycle
Key exclusion criteria (6 listed)
- Pregnancy in previous IVF or FET cycles
- Presence of hydrosalpinx not surgically corrected prior to FET
- Presence of endometrial polyp or fibroid distorting uterine cavity
- IVF cycles carried out for preimplantation genetic diagnosis
- Arrange for blastocyst transfer
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 |
|---|---|---|
| Endometrial biopsyThe procedure was performed in a standard approach using a Pipelle catheter (Pipelle de Cornier, Laboratoire C.C.D., France). The pipelle catheter was introduced through the cervix up to the uterine fundus. The piston was drawn back to the end of the sheath to create a negative pressure. The sheath was rotated and moved back and forth between the fundus and internal os for at least 3-4 times before it was gently withdrawn. | Procedure or surgery | EA |
| control procedureUsing pipelle catheter without entering the uterine cavity. | Procedure or surgery | Control |
| Pipelle catheter (Pipelle de Cornier, Laboratoire C.C.D., France) | Device | Control |
Primary outcome
Ongoing pregnancy rate
Time frame: pregnancy at 10-12 weeks
Pregnancy at 10-12 weeks
2 secondary outcomes
Implantation rate
Time frame: 4-6 weeks after embryo transfer
Clinical pregnancy rate
Time frame: 6 weeks after embryo transfer
Results and safety
The study was stopped early (reason given: Difficulty in recruiting participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2015.
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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.
Vivian CY Lee, MBBS principal investigator
Queen Mary Hospital / 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 Endometrial biopsy and Pipelle catheter (Pipelle de Cornier, Laboratoire C.C.D., France) in people with Subfertility, run by The University of Hong Kong at 1 site in Hong Kong.
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 6 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 11 Dec 2015. 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 Hong Kong. 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. Some participants in this study may receive a placebo. 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: Difficulty in recruiting participants.). 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?
Ongoing pregnancy rate (time frame: pregnancy at 10-12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Dec 2015.