Infertility Due to NonimplantationNCT03504345
Progesterone Supplementation in Frozen Embryo Transfer Cycles
A study testing Prometrium in people with Infertility Due to Nonimplantation and Infertility, run by Mount Sinai Hospital, Canada.
Trial summary
Recurrent implantation failure (RIF) occurs after women undergo in vitro fertilization and have multiple embryos transferred but no resulting pregnancies. RIF is a very challenging clinical entity for the reproductive physician and the patient. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility Due to Nonimplantation, Infertility
- What is being tested?
- Prometrium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- May 2018to Jul 2019
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient at Mount Sinai Fertility who wants to undertake a frozen embryo transfer
- History of recurrent implantation failure, defined as no pregnancy after three or more embryo transfers of four or more good quality blastocysts
Who cannot join
- Previous testing with Endometrial Receptivity Assay (ERA)
- Unable understand/communicate in English
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessing the Optimal Duration of Progesterone Supplementation Prior to Transfer of Frozen Embryos in the Recurrent Implantation Failure Population
Recurrent implantation failure (RIF) occurs after women undergo in vitro fertilization and have multiple embryos transferred but no resulting pregnancies. RIF is a very challenging clinical entity for the reproductive physician and the patient. In fact, there is not even an agreed upon definition in the medical community. Many potential causes have been investigated over the past several years but no clear answer has emerged. Interest has recently turned to the endometrium, or the lining of the uterus. Studies have shown that the genes that are turned on in the endometrium vary based on how long this tissue has been exposed to progesterone, an important hormone that prepares the uterine lining for implantation of the growing embryo. In some women, it seems that they require longer periods of progesterone exposure to reach the same state of readiness. We hypothesize that an even larger proportion of women in RIF population will require longer treatments with progesterone.
In this study, we will randomize women with RIF who are about to undergo a frozen embryo transfer to one of two groups. The first group will have their embryo transfer done on the standard sixth day of progesterone treatment. The other group will have their transfer done on the seventh day of progesterone. We will be comparing the clinical pregnancy rate of the two groups as well as the live birth rate and miscarriage rate. We expect that extending the progesterone treatment by one day will increase the pregnancy rate of women with RIF.
- Conditions
- Infertility Due to Nonimplantation, Infertility
- Being tested
- Prometrium
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrometriumDrug
The intervention will involve delaying the transfer of a frozen-thawed embryo into the uterus to increase the duration of progesterone exposure.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | This arm of the study will have their frozen-thawed embryo transfer take place on the sixth day of progesterone supplementation (Prometrium), which is the standard protocol in our clinic. Receives: Drug: Prometrium |
| Experimental Group | Experimental | This arm of the study will have their frozen-thawed embryo transfer take place on the seventh day of progesterone supplementation (Prometrium). Receives: Drug: Prometrium |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy rate
Rate of pregnancy, evidenced by clinical (fetal heartbeat) or ultrasound parameters (ultrasound visualization of a gestational sac, embryonic pole with heartbeat). It includes ectopic pregnancy.
Measured: 6 to 8 weeks after embryo transfer
Secondary outcomes (2)
Live birth rate
Rate of birth in which a fetus is delivered with signs of life after complete expulsion or extraction from its mother, beyond 20 completed weeks of gestational age
Measured: Approximately 9 months after embryo transfer
Miscarriage rate
Rate of natural death of embryo or fetus, after reaching clinical pregnancy stage and at or before 10 weeks gestation.
Measured: Approximately 3 months 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 posted20 Apr 2018
- Study startMay 2018 (estimated)
- Primary completionApr 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility Due to NonimplantationStudies 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
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Crystal Chan, Mount Sinai Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03504345
- Sponsor's protocol ID
- 000
- Status last verified
- Apr 2018
- First submitted
- 12 Apr 2018
- Last updated
- 20 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Optimal Duration of Progesterone Supplementation Prior to Transfer of Frozen Embryos in the Recurrent Implantation Failure Population
- ClinicalTrials.gov ID
- NCT03504345
- Acronym / sponsor ID
- 000
- Conditions
- Infertility Due to Nonimplantation, Infertility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Study start
- May 2018 (estimated)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 20 Apr 2018 (actual)
- 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.
Recurrent implantation failure (RIF) occurs after women undergo in vitro fertilization and have multiple embryos transferred but no resulting pregnancies. RIF is a very challenging clinical entity for the reproductive physician and the patient. In fact, there is not even an agreed upon definition in the medical community. Many potential causes have been investigated over the past several years but no clear answer has emerged. Interest has recently turned to the endometrium, or the lining of the uterus. Studies have shown that the genes that are turned on in the endometrium vary based on how long this tissue has been exposed to progesterone, an important hormone that prepares the uterine lining for implantation of the growing embryo. In some women, it seems that they require longer periods of progesterone exposure to reach the same state of readiness. We hypothesize that an even larger proportion of women in RIF population will require longer treatments with progesterone.
In this study, we will randomize women with RIF who are about to undergo a frozen embryo transfer to one of two groups. The first group will have their embryo transfer done on the standard sixth day of progesterone treatment. The other group will have their transfer done on the seventh day of progesterone. We will be comparing the clinical pregnancy rate of the two groups as well as the live birth rate and miscarriage rate. We expect that extending the progesterone treatment by one day will increase the pregnancy rate of women with RIF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Drug: PrometriumThis arm of the study will have their frozen-thawed embryo transfer take place on the sixth day of progesterone supplementation (Prometrium), which is the standard protocol in our clinic. |
| Experimental Group | Experimental | Drug: PrometriumThis arm of the study will have their frozen-thawed embryo transfer take place on the seventh day of progesterone supplementation (Prometrium). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patient at Mount Sinai Fertility who wants to undertake a frozen embryo transfer
- History of recurrent implantation failure, defined as no pregnancy after three or more embryo transfers of four or more good quality blastocysts
Key exclusion criteria (2 listed)
- Previous testing with Endometrial Receptivity Assay (ERA)
- Unable understand/communicate in English
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 |
|---|---|---|
| PrometriumThe intervention will involve delaying the transfer of a frozen-thawed embryo into the uterus to increase the duration of progesterone exposure. | Drug | Control Group, Experimental Group |
Primary outcome
clinical pregnancy rate
Time frame: 6 to 8 weeks after embryo transfer
Rate of pregnancy, evidenced by clinical (fetal heartbeat) or ultrasound parameters (ultrasound visualization of a gestational sac, embryonic pole with heartbeat). It includes ectopic pregnancy.
2 secondary outcomes
Live birth rate
Time frame: Approximately 9 months after embryo transfer
Miscarriage rate
Time frame: Approximately 3 months after embryo transfer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2018.
- Individual participant dataSharing planned: No
Related trials for Infertility Due to Nonimplantation
RecruitingObservational study
Impact of Endometrial Compaction on Reproductive Outcomes After Cryotransfer of Euploid Embryos in a Natural Cycle
Infertility Due to Nonimplantation
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.
Questions about this trial
What is this clinical trial studying?
A study testing Prometrium in people with Infertility Due to Nonimplantation and Infertility, run by Mount Sinai Hospital, Canada.
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 2 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: status not confirmed, as of the sponsor's last update on 20 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Crystal Chan, MD, MSc, FRCSC (416-586-4800 ext. 6024, crystal.chan@sinaihealthsystem.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical pregnancy rate (time frame: 6 to 8 weeks after embryo transfer). 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 20 Apr 2018.