InfertilityPhase 2IMPLANTNCT02310802
OBE001 Phase 2 Dose-finding Study Versus Placebo in Women Undergoing Embryo Transfer in the Context of IVF-ICSI
A Phase 2 study testing OBE001 dose 1, OBE001 dose 2 and OBE001 dose 3 in people with Infertility, run by ObsEva SA at 18 sites in 6 countries.
Trial summary
The primary objective of this study is to assess the increase in clinical pregnancy rate after administration of a range of single oral doses of OBE001, an oral oxytocin antagonist, compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 36 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- OBE001 dose 1, OBE001 dose 2 and OBE001 dose 3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 247 participants
- Where
- 18 sitesin 6 countries
- Study dates
- Nov 2014to Dec 2016
- Phase
- Phase 2
- 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 36 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with medically indicated IVF or ICSI using her own oocytes.
- GnRH antagonist protocol, a single injection of hCG for triggering final follicular maturation and luteal phase support with vaginal micronized progesterone.
- Evidence of uterine contractions by transvaginal ultrasound at baseline.
Who cannot join
- Blastocyst stage or frozen-thaw transfers
- Clinically significant abnormalities in ECG, vital signs, physical examination or clinical laboratory results
- Severe endometriosis and/or adenomyosis or risk of ovarian hyper stimulation syndrome
Trial locations and contacts
18 sites in 6 countries.
18 sites in 6 countries
Spain6 sites
Study site
Alicante
Study site
Barakaldo
Study site
Barcelona
Study site
Bilbao
Study site
Seville
Study site
Vigo
Czechia4 sites
Study site
Hradev Kralove
Study site
Olomouc
Study site
Prague
Study site
Zlín
Poland4 sites
Study site
Bialystok
Study site
Katowice
Study site
Szczecin
Study site
Warsaw
About this study
Official title: A Phase 2, Double-blind, Dose-finding, Placebo-controlled Study to Assess the Safety and Efficacy of a Single Oral Administration of OBE001 to Improve Embryo Implantation Following IVF or ICSI
The primary objective of this study is to assess the increase in clinical pregnancy rate after administration of a range of single oral doses of OBE001, an oral oxytocin antagonist, compared to placebo.
Read the detailed description
The study is a prospective, dose-finding, randomised, parallel group, double-blind, placebo-controlled study investigating the efficacy and the safety of the oxytocin receptor antagonist OBE001 in 240 women undergoing embryo transfer following IVF or ICSI.
The four-arm study (OBE001 dose 1, dose 2, dose 3, and placebo) design will allow evaluation of a possible dose-dependent pattern of action of OBE001 and, simultaneously, comparison of active compound with placebo with regard to both efficacy and safety.
- Conditions
- Infertility
- Being tested
- OBE001 dose 1, OBE001 dose 2, OBE001 dose 3, Placebo
- Keywords
- IVF, ICSI
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OBE001 dose 1Drug
OBE001 dispersible tablets for single oral administration
OBE001 dose 2Drug
OBE001 dispersible tablets for single oral administration
OBE001 dose 3Drug
OBE001 dispersible tablets for single oral administration
PlaceboDrug
Placebo dispersible tablets for single oral administration
| Study group | Role | What they receive |
|---|---|---|
| OBE001 dose 1 | Experimental | Not described Receives: Drug: OBE001 dose 1 |
| OBE001 dose 2 | Experimental | Not described Receives: Drug: OBE001 dose 2 |
| OBE001 dose 3 | Experimental | Not described Receives: Drug: OBE001 dose 3 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
EFFICACY ENDPOINTS Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat
Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat at about 6 weeks post ET day.
Measured: about 6 weeks post ET day
Secondary outcomes (4)
EFFICACY ENDPOINTS Percentage of women with positive blood pregnancy test
Percentage of women with positive blood pregnancy test at 14 days post OPU day.
Measured: 14 days post OPU day
EFFICACY ENDPOINTS Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat
Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat at 10 weeks post OPU day.
Measured: 10 weeks post OPU day
EFFICACY ENDPOINTS The embryo-implantation rate
The embryo-implantation rate defined as the number of intra-uterine embryos with positive heart-beat at 6 weeks post ET day divided by the number of embryos transferred
Measured: 6 weeks post ET day
EFFICACY ENDPOINTS Change from baseline to the time of ET in the rate of uterine contractions
Change from baseline to the time of ET in the rate of uterine contractions (UC/min).
Measured: at 3.5 hours after dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2015
- Study completionDec 2016
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 InfertilityStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- ObsEva SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Study Director, Study director, ObsEva SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02310802
- Sponsor's protocol ID
- 14-OBE001-013
- Acronym
- IMPLANT
- Status last verified
- Oct 2017
- First submitted
- 19 Nov 2014
- Last updated
- 23 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Griesinger G, Blockeel C, Pierzynski P, Tournaye H, Visnova H, Humberstone A, Terrill P, Pohl O, Garner E, Donnez J, Loumaye E. Effect of the oxytocin receptor antagonist nolasiban on pregnancy rates in women undergoing embryo transfer following IVF: analysis of three randomised clinical trials. Hum Reprod. 2021 Mar 18;36(4):1007-1020. doi: 10.1093/humrep/deaa369.
PubMed 33534895
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-blind, Dose-finding, Placebo-controlled Study to Assess the Safety and Efficacy of a Single Oral Administration of OBE001 to Improve Embryo Implantation Following IVF or ICSI
- ClinicalTrials.gov ID
- NCT02310802
- Acronym / sponsor ID
- IMPLANT / 14-OBE001-013
- Conditions
- Infertility
- Keywords
- IVF, ICSI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- ObsEva SAIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 8 Dec 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.
The primary objective of this study is to assess the increase in clinical pregnancy rate after administration of a range of single oral doses of OBE001, an oral oxytocin antagonist, compared to placebo.
Detailed description
The study is a prospective, dose-finding, randomised, parallel group, double-blind, placebo-controlled study investigating the efficacy and the safety of the oxytocin receptor antagonist OBE001 in 240 women undergoing embryo transfer following IVF or ICSI.
The four-arm study (OBE001 dose 1, dose 2, dose 3, and placebo) design will allow evaluation of a possible dose-dependent pattern of action of OBE001 and, simultaneously, comparison of active compound with placebo with regard to both efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| OBE001 dose 1 | Experimental | Drug: OBE001 dose 1 |
| OBE001 dose 2 | Experimental | Drug: OBE001 dose 2 |
| OBE001 dose 3 | Experimental | Drug: OBE001 dose 3 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women with medically indicated IVF or ICSI using her own oocytes.
- GnRH antagonist protocol, a single injection of hCG for triggering final follicular maturation and luteal phase support with vaginal micronized progesterone.
- Evidence of uterine contractions by transvaginal ultrasound at baseline.
Key exclusion criteria (3 listed)
- Blastocyst stage or frozen-thaw transfers
- Clinically significant abnormalities in ECG, vital signs, physical examination or clinical laboratory results
- Severe endometriosis and/or adenomyosis or risk of ovarian hyper stimulation syndrome
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 |
|---|---|---|
| OBE001 dose 1OBE001 dispersible tablets for single oral administration | Drug | OBE001 dose 1 |
| OBE001 dose 2OBE001 dispersible tablets for single oral administration | Drug | OBE001 dose 2 |
| OBE001 dose 3OBE001 dispersible tablets for single oral administration | Drug | OBE001 dose 3 |
| PlaceboPlacebo dispersible tablets for single oral administration | Drug | Placebo |
Primary outcome
EFFICACY ENDPOINTS Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat
Time frame: about 6 weeks post ET day
Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat at about 6 weeks post ET day.
4 secondary outcomes
EFFICACY ENDPOINTS Percentage of women with positive blood pregnancy test
Time frame: 14 days post OPU day
EFFICACY ENDPOINTS Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat
Time frame: 10 weeks post OPU day
EFFICACY ENDPOINTS The embryo-implantation rate
Time frame: 6 weeks post ET day
EFFICACY ENDPOINTS Change from baseline to the time of ET in the rate of uterine contractions
Time frame: at 3.5 hours after dose administration
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 23 Oct 2017.
- Derived from this study: PubMed 33534895Griesinger G, Blockeel C, Pierzynski P, Tournaye H, Visnova H, Humberstone A, Terrill P, Pohl O, Garner E, Donnez J, Loumaye E. Effect of the oxytocin receptor antagonist nolasiban on pregnancy rates in women undergoing embryo transfer following IVF: analysis of three randomised clinical trials. Hum Reprod. 2021 Mar 18;36(4):1007-1020. doi: 10.1093/humrep/deaa369.
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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.
Clinical Study Director study director
ObsEva SA
18 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OBE001 dose 1, OBE001 dose 2 and OBE001 dose 3 in people with Infertility, run by ObsEva SA at 18 sites in 6 countries.
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 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: finished, as of the sponsor's last update on 23 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Spain, Czechia, Poland, Denmark, Belgium and 1 more country. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
EFFICACY ENDPOINTS Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat (time frame: about 6 weeks post ET day). 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 NCT02310802, 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 23 Oct 2017.