Phase 3 Study to Evaluate the Efficacy and Safety of Pergoveris® in Assisted Reproductive Technology (ESPART)
ESPART
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
2 other identifiers
interventional
939
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2014
CompletedFirst Posted
Study publicly available on registry
January 28, 2014
CompletedStudy Start
First participant enrolled
January 31, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2015
CompletedResults Posted
Study results publicly available
January 24, 2017
CompletedAugust 24, 2017
July 1, 2017
1.6 years
January 24, 2014
August 24, 2016
July 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
At approximately 34 to 38 hours after r-hCG administration (Day 113)
Secondary Outcomes (5)
Ongoing Pregnancy Rate
70 days after embryo transfer (Day 185)
Live Birth Rate
Approximately 180 days following ongoing pregnancy determination (Day 365)
Embryo Implantation Rate
35-42 days post r-hCG administration (Day 154)
Clinical Pregnancy Rate
35-42 days post r-hCG administration (Day 154)
Biochemical Pregnancy Rate
15 to 20 days post r-hCG administration (Day 132)
Study Arms (2)
Pergoveris®
EXPERIMENTALGONAL-f®
ACTIVE COMPARATORInterventions
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 (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.
On r-hCG day, 250 mcg of r-hCG was administered once subcutaneously
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Please contact the Merck KGaA Communication Center
Darmstadt, Germany
Related Publications (2)
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.
PMID: 28137754RESULTHumaidan 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.
PMID: 26141305DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Merck KGaA Communication Center
- Organization
- Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany
Study Officials
- STUDY DIRECTOR
Medical Responsible
Merck KGaA, Darmstadt, Germany
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2014
First Posted
January 28, 2014
Study Start
January 31, 2014
Primary Completion
August 31, 2015
Study Completion
August 31, 2015
Last Updated
August 24, 2017
Results First Posted
January 24, 2017
Record last verified: 2017-07