InfertilityPhase 3IMPLANT2NCT03081208
Phase 3 Placebo Controlled Study of Nolasiban to Improve Pregnancy Rates in Women Undergoing IVF/ICSI
A Phase 3 study testing Nolasiban 900mg in people with Infertility, run by ObsEva SA at 43 sites in 9 countries.
Trial summary
The primary objective of this study is to confirm the efficacy of a single oral 900mg dose of nolasiban to increase the ongoing clinical pregnancy rate at 10 weeks post embryo transfer (ET) day. 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?
- Nolasiban 900mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 810 participants
- Where
- 43 sitesin 9 countries
- Study dates
- 6 Mar 2017to 19 Feb 2019
- Phase
- Phase 3
- 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
- Indicated for IVF/ICSI in the context of assisted reproductive technology (ART)
- Follow a gonadotropin releasing hormone (GnRH) antagonist protocol, single injection of human chorionic gonadotropin (hCG) for triggering final follicular maturation and luteal phase support with vaginal micronized progesterone.
- Single, fresh D3 or D5 embryo transfer
Who cannot join
- Frozen-thawed embryo transfer
- More than 20 oocytes in the current controlled ovarian hyperstimulation (COH) cycle
- Serum P4 greater than 1.5 ng/mL on the day of hCG administration
Trial locations and contacts
43 sites in 9 countries.
43 sites in 9 countries
Czechia8 sites
Investigator ID 1107
Olomouc
Investigator ID 1101
Prague
Investigator ID 1102
Prague
Investigator ID 1103
Prague
Investigator ID 1104
Prague
Investigator ID 1108
Prague
Investigator ID 1109
Teplice
Investigator ID 1106
Zlín
Spain8 sites
Investigator ID 1801
Barakaldo
Investigator ID 1805
Barcelona
Investigator ID 1808
Barcelona
Investigator ID 1809
Leioa
Investigator ID 1804
Madrid
Investigator ID 1807
Madrid
Investigator ID 1811
Seville
Investigator ID 1806
Valencia
Poland6 sites
Investigator ID 1701
Bialystok
Investigator ID 1703
Bialystok
Investigator ID 1705
Bialystok
Investigator ID 1702
Katowice
Investigator ID 1704
Szczecin
Investigator ID 1706
Warsaw
Belgium4 sites
Investigator ID 1001
Brussels
Investigator ID 1002
Brussels
Investigator ID 1003
Brussels
Investigator ID 1004
Brussels
Denmark4 sites
Investigator ID 1204
Copenhagen
Investigator ID 1205
Herlev
Investigator ID 1202
Hvidovre
Investigator ID 1203
Skive
Germany4 sites
Investigator ID 1501
Heidelberg
Investigator ID 1502
Lübeck
Investigator ID 1504
Mainz
Investigator ID 1503
Marburg
Hungary4 sites
Investigator ID 1601
Budapest
Investigator ID 1604
Budapest
Investigator ID 1603
Pécs
Investigator ID 1602
Tapolca
Finland3 sites
Investigator ID 1401
Helsinki
Investigator ID 1402
Helsinki
Investigator ID 1403
Oulu
About this study
Official title: A Phase 3, Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy and Safety of a Single Oral Administration of Nolasiban to Improve Pregnancy Rates Following IVF or ICSI in Day 3 and Day 5 Fresh Embryo Transfer Cycles
The primary objective of this study is to confirm the efficacy of a single oral 900mg dose of nolasiban to increase the ongoing clinical pregnancy rate at 10 weeks post embryo transfer (ET) day.
Read the detailed description
The study is a prospective, randomized, parallel group, double-blind, placebo-controlled study to confirm the efficacy and the safety of the oxytocin receptor antagonist, nolasiban, in 760 women undergoing fresh embryo transfer following in vitro fertilisation (IVF) or intra-cytoplasmic sperm injection (ICSI).
- Conditions
- Infertility
- Being tested
- Nolasiban 900mg, 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.
Nolasiban 900mgDrug
Nolasiban dispersible tablets for single oral administration
PlaceboDrug
Placebo dispersible tablets for single oral administration
| Study group | Role | What they receive |
|---|---|---|
| Nolasiban 900 mg | Experimental | Not described Receives: Drug: Nolasiban 900mg |
| 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.
Intra-uterine pregnancy with fetal heart beat at 10 weeks
Intra-uterine pregnancy with fetal heart beat at 10 weeks post embryo transfer day
Measured: 10 weeks post ET day
Secondary outcomes (4)
Live birth
Live birth after 24 weeks of gestation
Measured: Up to 42 weeks of gestation
Miscarriage
Any clinical pregnancy that does not result in a live birth prior 24 weeks
Measured: From 6 weeks post ET to 24 weeks gestation
Intra-uterine pregnancy at 6 weeks
Intra-uterine pregnancy with fetal heart beat at 6 weeks post ET day
Measured: 6 weeks post ET
Positive blood pregnancy test
Positive blood pregnancy test at 14 days post oocyte pick-up (OPU)
Measured: 14 days post OPU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2017
- Study start6 Mar 2017
- Primary completion21 Mar 2018
- Study completion19 Feb 2019
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 810 participants (actual)
Sponsor and investigators
- Lead sponsor
- ObsEva SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ObsEva SA, Study director, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03081208
- Sponsor's protocol ID
- 16-OBE001-005
- Acronym
- IMPLANT2
- Status last verified
- Dec 2019
- First submitted
- 6 Mar 2017
- Last updated
- 23 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy and Safety of a Single Oral Administration of Nolasiban to Improve Pregnancy Rates Following IVF or ICSI in Day 3 and Day 5 Fresh Embryo Transfer Cycles
- ClinicalTrials.gov ID
- NCT03081208
- Acronym / sponsor ID
- IMPLANT2 / 16-OBE001-005
- Conditions
- Infertility
- Keywords
- IVF, ICSI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 810 participants (actual)
- Lead sponsor
- ObsEva SAIndustry (pharma, biotech, devices)
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 21 Mar 2018 (actual)
- Study completion
- 19 Feb 2019 (actual)
- First posted
- 16 Mar 2017 (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.
The primary objective of this study is to confirm the efficacy of a single oral 900mg dose of nolasiban to increase the ongoing clinical pregnancy rate at 10 weeks post embryo transfer (ET) day.
Detailed description
The study is a prospective, randomized, parallel group, double-blind, placebo-controlled study to confirm the efficacy and the safety of the oxytocin receptor antagonist, nolasiban, in 760 women undergoing fresh embryo transfer following in vitro fertilisation (IVF) or intra-cytoplasmic sperm injection (ICSI).
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 |
|---|---|---|
| Nolasiban 900 mg | Experimental | Drug: Nolasiban 900mg |
| 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)
- Indicated for IVF/ICSI in the context of assisted reproductive technology (ART)
- Follow a gonadotropin releasing hormone (GnRH) antagonist protocol, single injection of human chorionic gonadotropin (hCG) for triggering final follicular maturation and luteal phase support with vaginal micronized progesterone.
- Single, fresh D3 or D5 embryo transfer
Key exclusion criteria (3 listed)
- Frozen-thawed embryo transfer
- More than 20 oocytes in the current controlled ovarian hyperstimulation (COH) cycle
- Serum P4 greater than 1.5 ng/mL on the day of hCG administration
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 |
|---|---|---|
| Nolasiban 900mgNolasiban dispersible tablets for single oral administration | Drug | Nolasiban 900 mg |
| PlaceboPlacebo dispersible tablets for single oral administration | Drug | Placebo |
Primary outcome
Intra-uterine pregnancy with fetal heart beat at 10 weeks
Time frame: 10 weeks post ET day
Intra-uterine pregnancy with fetal heart beat at 10 weeks post embryo transfer day
4 secondary outcomes
Live birth
Time frame: Up to 42 weeks of gestation
Miscarriage
Time frame: From 6 weeks post ET to 24 weeks gestation
Intra-uterine pregnancy at 6 weeks
Time frame: 6 weeks post ET
Positive blood pregnancy test
Time frame: 14 days post OPU
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 Dec 2019.
- 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.
ObsEva SA study director
Geneva
43 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nolasiban 900mg in people with Infertility, run by ObsEva SA at 43 sites in 9 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 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in Czechia, Spain, Poland, Belgium, Denmark and 4 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Intra-uterine pregnancy with fetal heart beat at 10 weeks (time frame: 10 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 NCT03081208, 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 Dec 2019.