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Phase 3 Study to Evaluate the Efficacy and Safety of Pergoveris® in Assisted Reproductive Technology (ESPART) (ESPART)

Primary Purpose

Infertility

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Pergoveris®
GONAL-f®
Recombinant human chorionic gonadotrophin (r-hCG)
Sponsored by
Merck KGaA, Darmstadt, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring ESPART, Reproductive Techniques, Assisted, Infertility, Pergoveris®, GONAL-f®

Eligibility Criteria

18 Years - 41 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Please contact the Merck KGaA Communication Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pergoveris®

GONAL-f®

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
Live Birth Rate
Live birth rate was defined as the percentage of subjects with at least one live-born neonate.
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.
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.
Biochemical Pregnancy Rate
Biochemical pregnancy rate was defined as the percentage of subjects with a positive beta-hCG result from the serum pregnancy test.

Full Information

First Posted
January 24, 2014
Last Updated
July 24, 2017
Sponsor
Merck KGaA, Darmstadt, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT02047227
Brief Title
Phase 3 Study to Evaluate the Efficacy and Safety of Pergoveris® in Assisted Reproductive Technology (ESPART)
Acronym
ESPART
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
January 31, 2014 (Actual)
Primary Completion Date
August 31, 2015 (Actual)
Study Completion Date
August 31, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck KGaA, Darmstadt, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
ESPART, Reproductive Techniques, Assisted, Infertility, Pergoveris®, GONAL-f®

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
939 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pergoveris®
Arm Type
Experimental
Arm Title
GONAL-f®
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Pergoveris®
Other Intervention Name(s)
r-hFSH/r-hLH, Follitropin alfa/Lutropin alfa
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
GONAL-f®
Other Intervention Name(s)
r-hFSH, Follitropin alfa
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Recombinant human chorionic gonadotrophin (r-hCG)
Other Intervention Name(s)
Ovidrel®, Ovitrelle®, choriogonadotropin alfa
Intervention Description
On r-hCG day, 250 mcg of r-hCG was administered once subcutaneously
Primary Outcome Measure Information:
Title
Number of Oocytes Retrieved
Description
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.
Time Frame
At approximately 34 to 38 hours after r-hCG administration (Day 113)
Secondary Outcome Measure Information:
Title
Ongoing Pregnancy Rate
Description
Ongoing pregnancy rate was defined as the percentage of subjects with a ultrasound confirmation of at least one viable fetus (positive fetal heart beat).
Time Frame
70 days after embryo transfer (Day 185)
Title
Live Birth Rate
Description
Live birth rate was defined as the percentage of subjects with at least one live-born neonate.
Time Frame
Approximately 180 days following ongoing pregnancy determination (Day 365)
Title
Embryo Implantation Rate
Description
Embryo implantation rate was measured as the number of gestational sacs observed divided by the number of embryos transferred multiplied by 100.
Time Frame
35-42 days post r-hCG administration (Day 154)
Title
Clinical Pregnancy Rate
Description
Clinical pregnancy rate defined as the percentage of subjects with a ultrasound confirmation of a gestational sac, with or without fetal heart activity.
Time Frame
35-42 days post r-hCG administration (Day 154)
Title
Biochemical Pregnancy Rate
Description
Biochemical pregnancy rate was defined as the percentage of subjects with a positive beta-hCG result from the serum pregnancy test.
Time Frame
15 to 20 days post r-hCG administration (Day 132)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
41 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Responsible
Organizational Affiliation
Merck KGaA, Darmstadt, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Please contact the Merck KGaA Communication Center
City
Darmstadt
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
28137754
Citation
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. Erratum In: Hum Reprod. 2017 Jul 1;32(7):1537-1538.
Results Reference
result
PubMed Identifier
26141305
Citation
Humaidan 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.
Results Reference
derived

Learn more about this trial

Phase 3 Study to Evaluate the Efficacy and Safety of Pergoveris® in Assisted Reproductive Technology (ESPART)

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