SubfertilityNCT01931384
A Study of Human Chorionic Gonadotrophin as Luteal Phase Support in Frozen Embryo Transfer
A study testing Human chorionic gonadotrophin in people with Subfertility, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
A randomised trial on the use of luteal phase support in frozen-thawed embryo transfer cycles. The hypothesis of the study is that the use of luteal phase support with human chorionic gonadotrophin would increase the pregnancy rate in frozen-thawed embryo transfer 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?
- Human chorionic gonadotrophin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 1 siteHong Kong
- Study dates
- Jul 2012to Dec 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
- Normal uterine cavity shown on pelvic scanning during the stimulated IVF cycle
- Endometrial thickness >=8mm in FET cycles
Who cannot join
- Subjects requiring clomid-induced cycles and hormonal replacement (HRT) cycles
- History of previous FET cycles within the study period
- Blastocyst transfer
- Use of donor oocytes
- Presence of hydrosalpinx not corrected surgically prior to FET
- Refusal to join the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Comparison of Human Chorionic Gonadotrophin as Luteal Phase Support in Frozen-thawed Embryo Transfer Cycles
A randomised trial on the use of luteal phase support in frozen-thawed embryo transfer cycles.
The hypothesis of the study is that the use of luteal phase support with human chorionic gonadotrophin would increase the pregnancy rate in frozen-thawed embryo transfer cycles.
Read the detailed description
Trial design:
-A total of 450 women undergoing FET in the Centre of Assisted Reproduction and Embryology, The University of Hong Kong-Queen Mary Hospital, will be recruited. They will be randomized into one of the following two groups by computer-generated random numbers:
Group I: luteal phase support using HCG 1500 IU intramuscular injection will be given on the day of FET and 6 days later.
Group II: normal saline (placebo) intramuscular injection will be given on the day of FET and 6 days later.
Treatment:
Ovarian stimulation protocol:
All women received ovarian stimulation according to the standard protocol of the Centre. HCG is given intramuscularly when the leading follicle reaches 18 mm in mean diameter. Oocyte retrieval is carried out 36 hours after the HCG trigger. A maximum of two embryos will transferred and any excess good quality embryos will be frozen two days after the retrieval.
FET cycle:
FET is carried out at least 2 month after the stimulated cycle if the patient fails to get pregnant in the stimulated IVF cycle and there is at least one frozen embryo. Frozen embryos after thawing are transferred in natural cycles for those women having regular ovulatory cycles, during which the patient is monitored daily for serum estradiol ad luteinising hormone levels from 18 days before the expected date of the next period.
The transfer is performed by the team clinician on the third day after the luteinising hormone surge and a maximum of two normally cleaving embryos are replaced according to our standard protocol. The luteal phase is supported as per randomization arm. Before the embryo transfer, the patient is interviewed by a designated research nurse who will explain the purpose of this study. Patients consenting to take part in the study will be assigned into one of the two study arms specified in an opaque envelope according to a computer-generated randomization list. The envelope will be read and injection (HCG or placebo as normal saline) given by a service nurse not involved in the study. Blood will be taken on day 6 after FET before the patient receives the second dose of HCG or placebo. A urine pregnancy test will be performed 16 days after the FET. In case of pregnancy, the outcome of pregnancy will be traced afterwards and used for analysis. Luteal phase support is not continued in those who get pregnant.
- Conditions
- Subfertility
- Being tested
- Human chorionic gonadotrophin, Placebo
- Keywords
- Luteal phase support, Human chorionic gonadotrophin, frozen-thawed embryo transfer cycle
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human chorionic gonadotrophinDrug
luteal phase support using Human chorionic gonadotrophin 1500 IU intramuscular injection will be given on the day of FET and 6 days later.
PlaceboDrug
Also called Normal saline
Normal saline intramuscularly on the day of embryo transfer and 5 days after embryo transfer.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | luteal phase support using Human chorionic gonadotrophin 1500 IU intramuscular injection will be given on the day of FET and 6 days later. Receives: Drug: Human chorionic gonadotrophin |
| control group | Placebo comparator | normal saline (placebo) intramuscular injection will be given on the day of FET and 6 days later Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ongoing pregnancy rate
ongoing pregnancy rate which is defined as the number of on-going pregnancies beyond 10-12 weeks gestation per transfer cycle
Measured: 4 months
Secondary outcomes (1)
Rate of pregnancy loss per number of transfer cycles
The pregnancy loss after embryo transfer counted
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startJul 2012
- Primary completionDec 2015
- Study completionDec 2015
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vivian Chi Yan Lee, MBBS, Principal investigator, HKU / QMH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01931384
- Sponsor's protocol ID
- HKU-VL-LPSRCT
- Status last verified
- Dec 2015
- First submitted
- 23 Aug 2013
- Last updated
- 11 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee VCY, Li RHW, Yeung WSB, Pak Chung HO, Ng EHY. A randomized double-blinded controlled trial of hCG as luteal phase support in natural cycle frozen embryo transfer. Hum Reprod. 2017 May 1;32(5):1130-1137. doi: 10.1093/humrep/dex049.
PubMed 28333292
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 Comparison of Human Chorionic Gonadotrophin as Luteal Phase Support in Frozen-thawed Embryo Transfer Cycles
- ClinicalTrials.gov ID
- NCT01931384
- Acronym / sponsor ID
- HKU-VL-LPSRCT
- Conditions
- Subfertility
- Keywords
- Luteal phase support, Human chorionic gonadotrophin, frozen-thawed embryo transfer cycle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 29 Aug 2013 (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.
A randomised trial on the use of luteal phase support in frozen-thawed embryo transfer cycles.
The hypothesis of the study is that the use of luteal phase support with human chorionic gonadotrophin would increase the pregnancy rate in frozen-thawed embryo transfer cycles.
Detailed description
Trial design:
-A total of 450 women undergoing FET in the Centre of Assisted Reproduction and Embryology, The University of Hong Kong-Queen Mary Hospital, will be recruited. They will be randomized into one of the following two groups by computer-generated random numbers:
Group I: luteal phase support using HCG 1500 IU intramuscular injection will be given on the day of FET and 6 days later.
Group II: normal saline (placebo) intramuscular injection will be given on the day of FET and 6 days later.
Treatment:
Ovarian stimulation protocol:
All women received ovarian stimulation according to the standard protocol of the Centre. HCG is given intramuscularly when the leading follicle reaches 18 mm in mean diameter. Oocyte retrieval is carried out 36 hours after the HCG trigger. A maximum of two embryos will transferred and any excess good quality embryos will be frozen two days after the retrieval.
FET cycle:
FET is carried out at least 2 month after the stimulated cycle if the patient fails to get pregnant in the stimulated IVF cycle and there is at least one frozen embryo. Frozen embryos after thawing are transferred in natural cycles for those women having regular ovulatory cycles, during which the patient is monitored daily for serum estradiol ad luteinising hormone levels from 18 days before the expected date of the next period.
The transfer is performed by the team clinician on the third day after the luteinising hormone surge and a maximum of two normally cleaving embryos are replaced according to our standard protocol. The luteal phase is supported as per randomization arm. Before the embryo transfer, the patient is interviewed by a designated research nurse who will explain the purpose of this study. Patients consenting to take part in the study will be assigned into one of the two study arms specified in an opaque envelope according to a computer-generated randomization list. The envelope will be read and injection (HCG or placebo as normal saline) given by a service nurse not involved in the study. Blood will be taken on day 6 after FET before the patient receives the second dose of HCG or placebo. A urine pregnancy test will be performed 16 days after the FET. In case of pregnancy, the outcome of pregnancy will be traced afterwards and used for analysis. Luteal phase support is not continued in those who get pregnant.
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 |
|---|---|---|
| Intervention group | Experimental | Drug: Human chorionic gonadotrophinluteal phase support using Human chorionic gonadotrophin 1500 IU intramuscular injection will be given on the day of FET and 6 days later. |
| control group | Placebo comparator | Drug: Placebonormal saline (placebo) intramuscular injection will be given on the day of FET and 6 days later |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Normal uterine cavity shown on pelvic scanning during the stimulated IVF cycle
- Endometrial thickness >=8mm in FET cycles
Key exclusion criteria (6 listed)
- Subjects requiring clomid-induced cycles and hormonal replacement (HRT) cycles
- History of previous FET cycles within the study period
- Blastocyst transfer
- Use of donor oocytes
- Presence of hydrosalpinx not corrected surgically prior to FET
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 |
|---|---|---|
| Human chorionic gonadotrophinluteal phase support using Human chorionic gonadotrophin 1500 IU intramuscular injection will be given on the day of FET and 6 days later. | Drug | Intervention group |
| PlaceboAlso: Normal salineNormal saline intramuscularly on the day of embryo transfer and 5 days after embryo transfer. | Drug | control group |
Primary outcome
ongoing pregnancy rate
Time frame: 4 months
ongoing pregnancy rate which is defined as the number of on-going pregnancies beyond 10-12 weeks gestation per transfer cycle
1 secondary outcome
Rate of pregnancy loss per number of transfer cycles
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2015.
- Derived from this study: PubMed 28333292Lee VCY, Li RHW, Yeung WSB, Pak Chung HO, Ng EHY. A randomized double-blinded controlled trial of hCG as luteal phase support in natural cycle frozen embryo transfer. Hum Reprod. 2017 May 1;32(5):1130-1137. doi: 10.1093/humrep/dex049.
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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 Chi Yan Lee, MBBS principal investigator
HKU / QMH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human chorionic gonadotrophin 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 2 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: finished, 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 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?
ongoing pregnancy rate (time frame: 4 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 NCT01931384, 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 11 Dec 2015; AzTrials last refreshed its copy on 6 Nov 2026.