PregnancyNCT02238431
Down-regulated Hormonally Controlled Cycles for Vitrification-warmed Blastocyst Transfers
A study testing Lucrin depot, OCP and Natural in people with Pregnancy, run by Antalya IVF at 1 site in Turkey (Türkiye).
Trial summary
Currently all patients that have freeze-all ICSI treatment cycles have the start of their FET cycle scheduled with the use of OCP. While an excellent pregnancy rate (75%) for the patients that have a blastocyst transfer has been maintained over time, 15% of started FET cycles are being cancelled because of premature… Read more about this study
- Who is it for?
- Ages 20 to 42 yearsHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Lucrin depot, OCP and Natural
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2014to Jun 2016
- 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 42 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- If patients have >2 blastocysts vitrified
Who cannot join
- All patients not willing to participate in the study
- Patients with any known adverse reaction to one or the other of the drugs prescribed
- All patients that have no surviving blastocysts for transfer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Down-regulated Hormonally Controlled Cycles for Vitrification-warmed Blastocyst Transfers: Reduces Time to Transfer and Cycle Cancellation
Currently all patients that have freeze-all ICSI treatment cycles have the start of their FET cycle scheduled with the use of OCP. While an excellent pregnancy rate (75%) for the patients that have a blastocyst transfer has been maintained over time, 15% of started FET cycles are being cancelled because of premature luteinization, and the treatment (to transfer) takes approximately 89 days. The use of a Lucrin depot may reduce the number of cycles cancelled and reduce the treatment time to approximately 69 days. The use of no drugs and allowing the normal menstrual cycle to determine the time to start the FET cycle may suit some patients. Whether these benefits can be obtained while still maintaining the current FET pregnancy rate will be the main focus of the trial.
Read the detailed description
The patients will undergo standard assisted conception procedures; controlled ovarian stimulation (COS), oocyte pickup procedure (OPU), ICSI, embryo culture, blastocyst vitrification and frozen embryo transfer. If sufficient (>2) viable blastocyst develop from the in vitro culture of their embryos, all viable blastocysts will be cryopreserved using a routine vitrification procedure. This is the eligible patient population. On the day the last blastocyst(s) are frozen the patients will be given a further opportunity to ask questions and if satisfied they will be asked to complete a trial consent. At this point patients will be randomized by numeric code and given a schedule and drug prescription for scheduling the start of their hormone supplemented frozen embryo transfer cycle. During the scheduling period the patients will follow the drug prescription provided . After the completion of their treatment - the transfer of one or two vitrified-warmed blastocyst - the patients from both groups will receive identical luteal support drug schedules and prescriptions. A blood test will be performed on the 15th day of progesterone supplementation, to determine the βhCG blood concentration. Currently at Antalya IVF, approximately 75% of patients who have blastocysts transferred in a frozen embryo transfer cycle have a positive biochemical pregnancy test, >29 international units per litre (IU/L) of human chorionic gonadotropin (βhCG). If pregnant, patients will continue using estrogen and progesterone supplementation for a further 8 weeks. At 7 weeks of gestation (5 weeks after embryo transfer ) the patients will receive a transvaginal ultrasound scan (TVUS) to check for pregnancy viability (fetal sac with cardiac activity). Thereafter the patients will have regular TVUS to follow fetal development. At 20 weeks of gestation a TVUS will be performed to confirm an ongoing pregnancy (normal fetal development).
All drug packs are delivered to the clinic by the pharmacy after receiving the prescription. A staff member will verify the code on the prescription with randomization code allocated to the patient. The pack will then be given to the patient after verbally confirming patient identity. The packs will also contain a drug use instruction sheet and a trial information sheet.
- Conditions
- Pregnancy
- Being tested
- Lucrin depot, OCP, Natural
- Keywords
- Lucrin depot,, frozen embryo transfer,, artificial cycle,, pregnancy,, cancellation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lucrin depotDrug
scheduling the start of the artificial cycle and hormone down regulation during the artificial cycle
OCPDrug
to schedule the start of the artificial cycle
NaturalOther
to use the normal menstrual period to schedule treatment start
| Study group | Role | What they receive |
|---|---|---|
| Lucrin depot, artificial cycle start | Experimental | intramuscular administration of Lucrin depot (half dose of 3.75mg) on the 5th day following oocyte retrieval Receives: Drug: Lucrin depot |
| OCP active, artificial cycle start | Active comparator | to take active OCP tablets (1 per day) from the 10th day following oocyte retrieval for at least 21 days Receives: Drug: OCP |
| Natural, menstrual period | Experimental | to wait for the second bleed to commence the artificial FET cycle Receives: Other: Natural |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cycle cancellation
blood progesterone concentration (>2nmol/L) as a measure of premature luteinization
Measured: On day 14 of estrogen supplementation
Secondary outcomes (1)
Ongoing pregnancy rate
TVUS normal fetal development >20 weeks of gestation, in case of a pregnancy
Measured: 20 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study startDec 2014
- Primary completionMay 2016 (estimated)
- Study completionJun 2016 (estimated)
Why it stopped: no patient uptake
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya IVF
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Coetzee, Antalya IVF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02238431
- Sponsor's protocol ID
- Lucrin depot FET cycle
- Other IDs
- FET cycle cancellation
- Status last verified
- May 2016
- First submitted
- 5 Sep 2014
- Last updated
- 26 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Gelbaya TA, Nardo LG, Hunter HR, Fitzgerald CT, Horne G, Pease EE, Brison DR, Lieberman BA. Cryopreserved-thawed embryo transfer in natural or down-regulated hormonally controlled cycles: a retrospective study. Fertil Steril. 2006 Mar;85(3):603-9. doi: 10.1016/j.fertnstert.2005.09.015.
PubMed 16500326Hill MJ, Miller KA, Frattarelli JL. A GnRH agonist and exogenous hormone stimulation protocol has a higher live-birth rate than a natural endogenous hormone protocol for frozen-thawed blastocyst-stage embryo transfer cycles: an analysis of 1391 cycles. Fertil Steril. 2010 Feb;93(2):416-22. doi: 10.1016/j.fertnstert.2008.11.027. Epub 2009 Jan 26.
PubMed 19171338Groenewoud ER, Cantineau AE, Kollen BJ, Macklon NS, Cohlen BJ. What is the optimal means of preparing the endometrium in frozen-thawed embryo transfer cycles? A systematic review and meta-analysis. Hum Reprod Update. 2013 Sep-Oct;19(5):458-70. doi: 10.1093/humupd/dmt030. Epub 2013 Jul 2.
PubMed 23820515
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Down-regulated Hormonally Controlled Cycles for Vitrification-warmed Blastocyst Transfers: Reduces Time to Transfer and Cycle Cancellation
- ClinicalTrials.gov ID
- NCT02238431
- Acronym / sponsor ID
- Lucrin depot FET cycle
- Conditions
- Pregnancy
- Keywords
- Lucrin depot,, frozen embryo transfer,, artificial cycle,, pregnancy,, cancellation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no patient uptake
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Antalya IVFUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- May 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 12 Sep 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.
Currently all patients that have freeze-all ICSI treatment cycles have the start of their FET cycle scheduled with the use of OCP. While an excellent pregnancy rate (75%) for the patients that have a blastocyst transfer has been maintained over time, 15% of started FET cycles are being cancelled because of premature luteinization, and the treatment (to transfer) takes approximately 89 days. The use of a Lucrin depot may reduce the number of cycles cancelled and reduce the treatment time to approximately 69 days. The use of no drugs and allowing the normal menstrual cycle to determine the time to start the FET cycle may suit some patients. Whether these benefits can be obtained while still maintaining the current FET pregnancy rate will be the main focus of the trial.
Detailed description
The patients will undergo standard assisted conception procedures; controlled ovarian stimulation (COS), oocyte pickup procedure (OPU), ICSI, embryo culture, blastocyst vitrification and frozen embryo transfer. If sufficient (>2) viable blastocyst develop from the in vitro culture of their embryos, all viable blastocysts will be cryopreserved using a routine vitrification procedure. This is the eligible patient population. On the day the last blastocyst(s) are frozen the patients will be given a further opportunity to ask questions and if satisfied they will be asked to complete a trial consent. At this point patients will be randomized by numeric code and given a schedule and drug prescription for scheduling the start of their hormone supplemented frozen embryo transfer cycle. During the scheduling period the patients will follow the drug prescription provided . After the completion of their treatment - the transfer of one or two vitrified-warmed blastocyst - the patients from both groups will receive identical luteal support drug schedules and prescriptions. A blood test will be performed on the 15th day of progesterone supplementation, to determine the βhCG blood concentration. Currently at Antalya IVF, approximately 75% of patients who have blastocysts transferred in a frozen embryo transfer cycle have a positive biochemical pregnancy test, >29 international units per litre (IU/L) of human chorionic gonadotropin (βhCG). If pregnant, patients will continue using estrogen and progesterone supplementation for a further 8 weeks. At 7 weeks of gestation (5 weeks after embryo transfer ) the patients will receive a transvaginal ultrasound scan (TVUS) to check for pregnancy viability (fetal sac with cardiac activity). Thereafter the patients will have regular TVUS to follow fetal development. At 20 weeks of gestation a TVUS will be performed to confirm an ongoing pregnancy (normal fetal development).
All drug packs are delivered to the clinic by the pharmacy after receiving the prescription. A staff member will verify the code on the prescription with randomization code allocated to the patient. The pack will then be given to the patient after verbally confirming patient identity. The packs will also contain a drug use instruction sheet and a trial information sheet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lucrin depot, artificial cycle start | Experimental | Drug: Lucrin depotintramuscular administration of Lucrin depot (half dose of 3.75mg) on the 5th day following oocyte retrieval |
| OCP active, artificial cycle start | Active comparator | Drug: OCPto take active OCP tablets (1 per day) from the 10th day following oocyte retrieval for at least 21 days |
| Natural, menstrual period | Experimental | Other: Naturalto wait for the second bleed to commence the artificial FET cycle |
Who may qualify
- Ages
- 20 to 42 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- If patients have >2 blastocysts vitrified
Key exclusion criteria (3 listed)
- All patients not willing to participate in the study
- Patients with any known adverse reaction to one or the other of the drugs prescribed
- All patients that have no surviving blastocysts for 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 |
|---|---|---|
| Lucrin depotscheduling the start of the artificial cycle and hormone down regulation during the artificial cycle | Drug | Lucrin depot, artificial cycle start |
| OCPto schedule the start of the artificial cycle | Drug | OCP active, artificial cycle start |
| Naturalto use the normal menstrual period to schedule treatment start | Other | Natural, menstrual period |
Primary outcome
Cycle cancellation
Time frame: On day 14 of estrogen supplementation
blood progesterone concentration (>2nmol/L) as a measure of premature luteinization
1 secondary outcome
Ongoing pregnancy rate
Time frame: 20 weeks of gestation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2016.
- Background: PubMed 16500326Gelbaya TA, Nardo LG, Hunter HR, Fitzgerald CT, Horne G, Pease EE, Brison DR, Lieberman BA. Cryopreserved-thawed embryo transfer in natural or down-regulated hormonally controlled cycles: a retrospective study. Fertil Steril. 2006 Mar;85(3):603-9. doi: 10.1016/j.fertnstert.2005.09.015.
- Background: PubMed 19171338Hill MJ, Miller KA, Frattarelli JL. A GnRH agonist and exogenous hormone stimulation protocol has a higher live-birth rate than a natural endogenous hormone protocol for frozen-thawed blastocyst-stage embryo transfer cycles: an analysis of 1391 cycles. Fertil Steril. 2010 Feb;93(2):416-22. doi: 10.1016/j.fertnstert.2008.11.027. Epub 2009 Jan 26.
- Results publication: PubMed 23820515Groenewoud ER, Cantineau AE, Kollen BJ, Macklon NS, Cohlen BJ. What is the optimal means of preparing the endometrium in frozen-thawed embryo transfer cycles? A systematic review and meta-analysis. Hum Reprod Update. 2013 Sep-Oct;19(5):458-70. doi: 10.1093/humupd/dmt030. Epub 2013 Jul 2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lucrin depot, OCP and Natural in people with Pregnancy, run by Antalya IVF at 1 site in Turkey (Türkiye).
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 1 inclusion and 3 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: withdrawn, as of the sponsor's last update on 26 May 2016. 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 Turkey (Türkiye). 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 withdrawn before enrolling participants, so there are no results.
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?
Cycle cancellation (time frame: On day 14 of estrogen supplementation). 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 NCT02238431, which also lists 3 linked publications.
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 26 May 2016.