Phase 3
N=939
Phase 3 Study to Evaluate the Efficacy and Safety of Pergoveris® in Assisted Reproductive Technology (ESPART)
Infertility
Bottom Line
View on ClinicalTrials.gov: NCT02047227 ↗Enrolled (actual)
939
Serious AEs
2.7%
Results posted
Jan 2017
Primary outcome: Primary: Number of Oocytes Retrieved — 3.3; 3.6 oocytes — p=0.054
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pergoveris® (Drug); GONAL-f® (Drug); Recombinant human chorionic gonadotrophin (r-hCG) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Merck KGaA, Darmstadt, Germany
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Oocytes Retrieved |
3.3; 3.6 | 0.054 |
| SECONDARY Ongoing Pregnancy Rate |
11.0; 12.4 | — |
| SECONDARY Live Birth Rate |
10.6; 11.7 | — |
| SECONDARY Embryo Implantation Rate |
14.7; 15.6 | — |
| SECONDARY Clinical Pregnancy Rate |
14.1; 16.8 | — |
| SECONDARY Biochemical Pregnancy Rate |
17.3; 23.9 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- Other protocol defined exclusion criteria could apply
Data sourced from ClinicalTrials.gov (NCT02047227). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.