InfertilityPhase 3IMPLANT4NCT03758885
Study of Nolasiban to Increase Pregnancy Rates in Women Undergoing IVF
A Phase 3 study testing Nolasiban in people with Infertility, run by ObsEva SA at 50 sites in 10 countries.
Trial summary
The primary objective of this study is to confirm the efficacy of a single oral 900 mg dose of nolasiban versus placebo 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 37 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Nolasiban
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 820 participants
- Where
- 50 sitesin 10 countries
- Study dates
- 10 Jan 2019to 11 Nov 2020
- 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 37 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 support with vaginal micronized progesterone.
- Single fresh D5 embryo transfer
Who cannot join
- Frozen-thawed embryo transfer
- Donor egg in the current transfer
- More than 20 oocytes in the current controlled ovarian hyperstimulation (COH) cycle
- Serum P4 greater than 1.5 ng/mL prior to hCG administration
Trial locations and contacts
50 sites in 10 countries.
50 sites in 10 countries
Czechia10 sites
Site 1107
Olomouc
Site 1101
Prague
Site 1102
Prague
Site 1103
Prague
Site 1104
Prague
Site 1105
Prague
Site 1108
Prague
Site 1110
Prague
Site 1109
Teplice
Site 1106
Zlín
Germany6 sites
Site 1504
Berlin
Site 1506
Berlin
Site 1505
Bielefeld
Site 1501
Heidelberg
Site 1502
Lübeck
Site 1503
Marburg
Poland6 sites
Site 1703
Bialystok
Site 1705
Bialystok
Site 1702
Katowice
Site 1701
Krakow
Site 1704
Szczecin
Site 1706
Warsaw
Spain6 sites
Site 1805
Barcelona
Site 1808
Barcelona
Site 1809
Leioa
Site 1804
Madrid
Site 1807
Madrid
Site 1811
Seville
Belgium4 sites
Site 1001
Brussels
Site 1002
Brussels
Site 1003
Brussels
Site 1004
Brussels
Canada4 sites
Site 1404
Burnaby
Site 1401
Montreal
Site 1402
Toronto
Site 1403
Toronto
Denmark4 sites
Site 1204
Copenhagen
Site 1205
Herlev
Site 1202
Hvidovre
Site 1203
Skive
Russia4 sites
Site 1901
Moscow
Site 1905
Moscow
Site 1904
Samara
Site 1902
Yekaterinburg
About this study
Official title: A Phase 3, Double-blind, Randomized, Placebo-controlled Study to Assess the Safety and Efficacy of a Single Oral Administration of Nolasiban to Increase On-going Pregnancy Rate Following Fresh Single Blastocyst Transfer Resulting From IVF
The primary objective of this study is to confirm the efficacy of a single oral 900 mg dose of nolasiban versus placebo to increase the ongoing clinical pregnancy rate at 10 weeks post-embryo transfer (ET) day.
Read the detailed description
The study is a prospective, randomised, parallel group, double-blind, placebo-controlled, Phase 3 study to confirm the efficacy and the safety of nolasiban versus placebo to increase pregnancy and live birth rates in 820 women undergoing fresh single blastocyst transfer following in vitro fertilisation (IVF) or intra-cytoplasmic sperm injection (ICSI).
- Conditions
- Infertility
- Being tested
- Nolasiban, Placebo
- Keywords
- IVF, ICSI, ART, ET
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NolasibanDrug
Nolasiban single oral administration
PlaceboDrug
Placebo single oral administration
| Study group | Role | What they receive |
|---|---|---|
| Nolasiban 900 mg | Experimental | Nolasiban dispersible tablets for single oral administration Receives: Drug: Nolasiban |
| Placebo | Placebo comparator | Placebo dispersible tablets for single oral administration Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy with fetal heart beat at 10 weeks
Ongoing pregnancy defined as an intra-uterine pregnancy with fetal heart beat at 10 weeks post embryo transfer day
Measured: 10 weeks post ET day
Secondary outcomes (5)
Live birth
Live birth after 24 weeks of gestation
Measured: 24 to 40 weeks of gestation
Clinical pregnancy at 6 weeks post ET day
Clinical pregnancy defined as intra-uterine pregnancy with fetal heart beat at 6 weeks post-ET day
Measured: 6 weeks post ET
Pregnancy rate at 14 days post Oocyte Pick-up (OPU)
Positive blood pregnancy test at 14 days post OPU day
Measured: 14 days post OPU
Pregnancy loss
Pregnancy loss at 6 or 10 weeks after ET and before 24 weeks of gestation
Measured: 6 weeks post ET to 24 weeks gestation
Plasma concentrations of nolasiban
Plasma concentrations of nolasiban after administration
Measured: 3.5 hours, 5 hours and at 7 hours (latest 72 hours) after nolasiban administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start10 Jan 2019
- Primary completion21 Nov 2019
- Study completion11 Nov 2020
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
- 820 participants (actual)
Sponsor and investigators
- Lead sponsor
- ObsEva SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03758885
- Sponsor's protocol ID
- 18-OBE001-010
- Acronym
- IMPLANT4
- Status last verified
- Sep 2020
- First submitted
- 28 Nov 2018
- Last updated
- 9 Sep 2021
- 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 9 Sep 2021. 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 Safety and Efficacy of a Single Oral Administration of Nolasiban to Increase On-going Pregnancy Rate Following Fresh Single Blastocyst Transfer Resulting From IVF
- ClinicalTrials.gov ID
- NCT03758885
- Acronym / sponsor ID
- IMPLANT4 / 18-OBE001-010
- Conditions
- Infertility
- Keywords
- IVF, ICSI, ART, ET
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 820 participants (actual)
- Lead sponsor
- ObsEva SAIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 21 Nov 2019 (actual)
- Study completion
- 11 Nov 2020 (actual)
- First posted
- 29 Nov 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.
The primary objective of this study is to confirm the efficacy of a single oral 900 mg dose of nolasiban versus placebo to increase the ongoing clinical pregnancy rate at 10 weeks post-embryo transfer (ET) day.
Detailed description
The study is a prospective, randomised, parallel group, double-blind, placebo-controlled, Phase 3 study to confirm the efficacy and the safety of nolasiban versus placebo to increase pregnancy and live birth rates in 820 women undergoing fresh single blastocyst 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: NolasibanNolasiban dispersible tablets for single oral administration |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo dispersible tablets for single oral administration |
Who may qualify
- Ages
- 18 to 37 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 support with vaginal micronized progesterone.
- Single fresh D5 embryo transfer
Key exclusion criteria (4 listed)
- Frozen-thawed embryo transfer
- Donor egg in the current transfer
- More than 20 oocytes in the current controlled ovarian hyperstimulation (COH) cycle
- Serum P4 greater than 1.5 ng/mL prior to 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 |
|---|---|---|
| NolasibanNolasiban single oral administration | Drug | Nolasiban 900 mg |
| PlaceboPlacebo single oral administration | Drug | Placebo |
Primary outcome
Ongoing pregnancy with fetal heart beat at 10 weeks
Time frame: 10 weeks post ET day
Ongoing pregnancy defined as an intra-uterine pregnancy with fetal heart beat at 10 weeks post embryo transfer day
5 secondary outcomes
Live birth
Time frame: 24 to 40 weeks of gestation
Clinical pregnancy at 6 weeks post ET day
Time frame: 6 weeks post ET
Pregnancy rate at 14 days post Oocyte Pick-up (OPU)
Time frame: 14 days post OPU
Pregnancy loss
Time frame: 6 weeks post ET to 24 weeks gestation
Plasma concentrations of nolasiban
Time frame: 3.5 hours, 5 hours and at 7 hours (latest 72 hours) after nolasiban 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 9 Sep 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
50 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nolasiban in people with Infertility, run by ObsEva SA at 50 sites in 10 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 4 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 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in Czechia, Germany, Poland, Spain, Belgium and 5 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?
Ongoing 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 NCT03758885, 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 9 Sep 2021.