InfertilityPhase 3ESPARTNCT02047227
Phase 3 Study to Evaluate the Efficacy and Safety of Pergoveris® in Assisted Reproductive Technology (ESPART)
A Phase 3 study testing Pergoveris®, GONAL-f® and Recombinant human chorionic gonadotrophin (r-hCG) in people with Infertility, run by Merck KGaA, Darmstadt, Germany at 1 site in Germany.
Trial summary
This is a Phase 3, randomized, controlled, single-blind, multicenter, parallel-arm trial to assess the safety and efficacy of Pergoveris® (recombinant human follicle stimulating hormone [r-hFSH]/recombinant human luteinising hormone [r-hLH]) and GONAL-f® for multifollicular development as part of an assisted… Read more about this study
- Who is it for?
- Ages 18 to 41 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Pergoveris®, GONAL-f® and Recombinant human chorionic gonadotrophin (r-hCG)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 939 participants
- Where
- 1 siteGermany
- Study dates
- 31 Jan 2014to 31 Aug 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 41 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Poor ovarian responders according to specific criteria that are aligned with poor ovarian response (POR) criteria defined by the 2011 Consensus Meeting of the European Society of Human Reproduction and Embryology (ESHRE) as mentioned in the protocol
- Female subjects, less than (<) 41 years of age (according to date of birth at time of informed consent) who are eligible for ovarian stimulation and ART treatment, including intracytoplasmic sperm injection (ICSI)
- Absence of anatomical abnormalities of the reproductive tract that would interfere with implantation or pregnancy
- Absence of any medical condition in which pregnancy is contraindicated
- Body mass index 18 to 30 kilogram per square meter (kg/m^2), inclusive
- Motile, ejaculatory sperm must be available (donated and/or cryopreserved sperm is allowed). Intracytoplasmic sperm injection will be allowed during this trial
- Minimum of 1 month without treatment with either clomiphene citrate or gonadotrophins prior to screening
- Signed and dated informed consent indicating that the subject has been informed of all the pertinent aspects of the trial prior to enrollment
Who cannot join
- Two episodes of POR after maximal stimulation
- History or presence of tumors of the hypothalamus or pituitary gland
- History or presence of ovarian enlargement or cyst of unknown etiology, or presence of an ovarian cyst greater than 25 mm on the day of randomization
- Presence of endometriosis Grade III - IV, confirmed or suspected
- Presence of uni- or bilateral hydrosalpinx
- Abnormal gynecological bleeding of undetermined origin
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- Contraindication to being pregnant and/or carrying a pregnancy to term
- History or presence of ovarian, uterine or mammary cancer
- Use of testicular or epididymal sperm
- Other protocol defined exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III, Randomized, Controlled, Single-blind, Multicentre, Parallel Arm Trial to Assess the Efficacy and Safety of Pergoveris® (Follitropin Alfa and Lutropin Alfa) and GONAL-f® (Follitropin Alfa) for Multifollicular Development as Part of an Assisted Reproductive Technology Treatment Cycle in Poor Ovarian Responders, as Defined by the European Society of Human Reproduction and Embryology Criteria
This is a Phase 3, randomized, controlled, single-blind, multicenter, parallel-arm trial to assess the safety and efficacy of Pergoveris® (recombinant human follicle stimulating hormone [r-hFSH]/recombinant human luteinising hormone [r-hLH]) and GONAL-f® for multifollicular development as part of an assisted reproductive technology (ART) treatment cycle in poor ovarian responders, as aligned with the 2011 Consensus Meeting of the European Society of Human Reproduction and Embryology (ESHRE) criteria.
- Conditions
- Infertility
- Being tested
- Pergoveris®, GONAL-f®, Recombinant human chorionic gonadotrophin (r-hCG)
- Keywords
- ESPART, Reproductive Techniques, Assisted, Infertility, Pergoveris®, GONAL-f®
- Medical subject headings
- Infertility, Helping Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pergoveris®Drug
Also called r-hFSH/r-hLH, Follitropin alfa/Lutropin alfa
Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 International Unit (IU) recombinant human follicular stimulating hormone (rhFSH)/ 150 IU recombinant human luteinizing hormone (rhLH) after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 millimeter (mm); 250 microgram (mcg) of r-hCG (Ovidrel) was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject's response per site standard clinical practice.
GONAL-f®Drug
Also called r-hFSH, Follitropin alfa
GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject's response per site standard clinical practice.
Recombinant human chorionic gonadotrophin (r-hCG)Drug
Also called Ovidrel®, Ovitrelle®, choriogonadotropin alfa
On r-hCG day, 250 mcg of r-hCG was administered once subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Pergoveris® | Experimental | Not described Receives: Drug: Pergoveris®; Drug: Recombinant human chorionic gonadotrophin (r-hCG) |
| GONAL-f® | Active comparator | Not described Receives: Drug: GONAL-f®; Drug: Recombinant human chorionic gonadotrophin (r-hCG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Oocytes Retrieved
Mean number of oocytes retrieved on the day of ovum pick up (OPU) was calculated. Oocyte retrieval was a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.
Measured: At approximately 34 to 38 hours after r-hCG administration (Day 113)
Secondary outcomes (5)
Ongoing Pregnancy Rate
Ongoing pregnancy rate was defined as the percentage of subjects with a ultrasound confirmation of at least one viable fetus (positive fetal heart beat).
Measured: 70 days after embryo transfer (Day 185)
Live Birth Rate
Live birth rate was defined as the percentage of subjects with at least one live-born neonate.
Measured: Approximately 180 days following ongoing pregnancy determination (Day 365)
Embryo Implantation Rate
Embryo implantation rate was measured as the number of gestational sacs observed divided by the number of embryos transferred multiplied by 100.
Measured: 35-42 days post r-hCG administration (Day 154)
Clinical Pregnancy Rate
Clinical pregnancy rate defined as the percentage of subjects with a ultrasound confirmation of a gestational sac, with or without fetal heart activity.
Measured: 35-42 days post r-hCG administration (Day 154)
Biochemical Pregnancy Rate
Biochemical pregnancy rate was defined as the percentage of subjects with a positive beta-hCG result from the serum pregnancy test.
Measured: 15 to 20 days post r-hCG administration (Day 132)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study start31 Jan 2014
- Primary completion31 Aug 2015
- Study completion31 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 939 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02047227
- Sponsor's protocol ID
- EMR200061-005
- Other IDs
- 2013-003817-16
- Acronym
- ESPART
- Status last verified
- Jul 2017
- First submitted
- 24 Jan 2014
- Last updated
- 24 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Humaidan P, Chin W, Rogoff D, D'Hooghe T, Longobardi S, Hubbard J, Schertz J; ESPART Study Investigatorsdouble dagger. Efficacy and safety of follitropin alfa/lutropin alfa in ART: a randomized controlled trial in poor ovarian responders. Hum Reprod. 2017 Mar 1;32(3):544-555. doi: 10.1093/humrep/dew360.
PubMed 28137754Humaidan P, Schertz J, Fischer R. Efficacy and Safety of Pergoveris in Assisted Reproductive Technology--ESPART: rationale and design of a randomised controlled trial in poor ovarian responders undergoing IVF/ICSI treatment. BMJ Open. 2015 Jul 3;5(7):e008297. doi: 10.1136/bmjopen-2015-008297.
PubMed 26141305
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Controlled, Single-blind, Multicentre, Parallel Arm Trial to Assess the Efficacy and Safety of Pergoveris® (Follitropin Alfa and Lutropin Alfa) and GONAL-f® (Follitropin Alfa) for Multifollicular Development as Part of an Assisted Reproductive Technology Treatment Cycle in Poor Ovarian Responders, as Defined by the European Society of Human Reproduction and Embryology Criteria
- ClinicalTrials.gov ID
- NCT02047227
- Acronym / sponsor ID
- ESPART / EMR200061-005
- Conditions
- Infertility
- Keywords
- ESPART, Reproductive Techniques, Assisted, Infertility, Pergoveris®, GONAL-f®
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 939 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2014 (actual)
- Primary completion
- 31 Aug 2015 (actual)
- Study completion
- 31 Aug 2015 (actual)
- First posted
- 28 Jan 2014 (estimated)
- Results
- Posted 24 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 3, randomized, controlled, single-blind, multicenter, parallel-arm trial to assess the safety and efficacy of Pergoveris® (recombinant human follicle stimulating hormone [r-hFSH]/recombinant human luteinising hormone [r-hLH]) and GONAL-f® for multifollicular development as part of an assisted reproductive technology (ART) treatment cycle in poor ovarian responders, as aligned with the 2011 Consensus Meeting of the European Society of Human Reproduction and Embryology (ESHRE) criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pergoveris® | Experimental | Drug: Pergoveris®, Drug: Recombinant human chorionic gonadotrophin (r-hCG) |
| GONAL-f® | Active comparator | Drug: GONAL-f®, Drug: Recombinant human chorionic gonadotrophin (r-hCG) |
Who may qualify
- Ages
- 18 to 41 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Poor ovarian responders according to specific criteria that are aligned with poor ovarian response (POR) criteria defined by the 2011 Consensus Meeting of the European Society of Human Reproduction and Embryology (ESHRE) as mentioned in the protocol
- Female subjects, less than (<) 41 years of age (according to date of birth at time of informed consent) who are eligible for ovarian stimulation and ART treatment, including intracytoplasmic sperm injection (ICSI)
- Absence of anatomical abnormalities of the reproductive tract that would interfere with implantation or pregnancy
- Absence of any medical condition in which pregnancy is contraindicated
- Body mass index 18 to 30 kilogram per square meter (kg/m^2), inclusive
Key exclusion criteria (10 listed)
- Two episodes of POR after maximal stimulation
- History or presence of tumors of the hypothalamus or pituitary gland
- History or presence of ovarian enlargement or cyst of unknown etiology, or presence of an ovarian cyst greater than 25 mm on the day of randomization
- Presence of endometriosis Grade III - IV, confirmed or suspected
- Presence of uni- or bilateral hydrosalpinx
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 |
|---|---|---|
| Pergoveris®Also: r-hFSH/r-hLH, Follitropin alfa/Lutropin alfaPergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 International Unit (IU) recombinant human follicular stimulating hormone (rhFSH)/ 150 IU recombinant human luteinizing hormone (rhLH) after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 millimeter (mm); 250 microgram (mcg) of r-hCG (Ovidrel) was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject's response per site standard clinical practice. | Drug | Pergoveris® |
| GONAL-f®Also: r-hFSH, Follitropin alfaGONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject's response per site standard clinical practice. | Drug | GONAL-f® |
| Recombinant human chorionic gonadotrophin (r-hCG)Also: Ovidrel®, Ovitrelle®, choriogonadotropin alfaOn r-hCG day, 250 mcg of r-hCG was administered once subcutaneously | Drug | GONAL-f®, Pergoveris® |
Primary outcome
Number of Oocytes Retrieved
Time frame: At approximately 34 to 38 hours after r-hCG administration (Day 113)
Mean number of oocytes retrieved on the day of ovum pick up (OPU) was calculated. Oocyte retrieval was a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.
5 secondary outcomes
Ongoing Pregnancy Rate
Time frame: 70 days after embryo transfer (Day 185)
Live Birth Rate
Time frame: Approximately 180 days following ongoing pregnancy determination (Day 365)
Embryo Implantation Rate
Time frame: 35-42 days post r-hCG administration (Day 154)
Clinical Pregnancy Rate
Time frame: 35-42 days post r-hCG administration (Day 154)
Biochemical Pregnancy Rate
Time frame: 15 to 20 days post r-hCG administration (Day 132)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28137754Humaidan P, Chin W, Rogoff D, D'Hooghe T, Longobardi S, Hubbard J, Schertz J; ESPART Study Investigatorsdouble dagger. Efficacy and safety of follitropin alfa/lutropin alfa in ART: a randomized controlled trial in poor ovarian responders. Hum Reprod. 2017 Mar 1;32(3):544-555. doi: 10.1093/humrep/dew360.
- Derived from this study: PubMed 26141305Humaidan P, Schertz J, Fischer R. Efficacy and Safety of Pergoveris in Assisted Reproductive Technology--ESPART: rationale and design of a randomised controlled trial in poor ovarian responders undergoing IVF/ICSI treatment. BMJ Open. 2015 Jul 3;5(7):e008297. doi: 10.1136/bmjopen-2015-008297.
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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.
Medical Responsible study director
Merck KGaA, Darmstadt, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pergoveris®, GONAL-f® and Recombinant human chorionic gonadotrophin (r-hCG) in people with Infertility, run by Merck KGaA, Darmstadt, Germany at 1 site in Germany.
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 8 inclusion and 10 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 24 Aug 2017. 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 Germany. 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.
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?
Yes. Results are posted in the registry (first posted 24 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Oocytes Retrieved (time frame: At approximately 34 to 38 hours after r-hCG administration (Day 113)). 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 NCT02047227, which also lists 2 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 24 Aug 2017.