A study to compare Pergoveris and GONAL-f in women who have responded poorly to previous infertiliy treatment cycles

• Conditions: Poor Ovarian Response i.e. a failure to respond adequately to standard ART (assisted reproductive technologies) protocols and to recruit adequate follicles; MedDRA version: 17.0Level: LLTClassification code 10033140Term: Ovarian disorder NOSSystem Organ Class: 100000004872; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2013-003817-16-SE
• Lead Sponsor: Merck KGaA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-19
• Last Update Posted: 26 October 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 946

Inclusion Criteria

The current trial will enroll poor ovarian responders as aligned with the 2011 Consensus Meeting of the ESHRE
1. Subject must be a poor responder
at least 2 of the following 3 features must be present:
? ESHRE criteria = Advanced maternal age (= 40 years) or any risk factor for POR - INCLUSION for this study: Yes (< 41 years), no for any risk factor
? ESHRE Criteria = A previous POR (= 3 oocytes with a conventional stimulation protocol)
INCLUSION for this study: Yes
? ESHRE Criteria = An abnormal ovarian reserve test (ORT) (ie, anti-mullerian hormone [AMH] < 0.5 - 1.1 ng mL)
INCLUSION for this study: Yes for AMH only (= lower limit of assay detection – 1.3 ng/mL, inclusive)

Additional inclusion criteria are:
2.Female subjects, 18 to < 41 years of age (according to date of birth at time of informed consent) who are eligible for ovarian stimulation and ART treatment, including ICSI
3.Absence of anatomical abnormalities of the reproductive tract that would interfere with implantation or pregnancy
4.Absence of any medical condition in which pregnancy is contraindicated
5.Body mass index 18 to 30 kg/m2, inclusive
6.Motile, ejaculatory sperm must be available (donated and/or cryopreserved sperm is allowed). Intracytoplasmic sperm injection will be allowed during this trial.
7.Minimum of 1 month without treatment with either clomiphene citrate or gonadotrophins prior to screening
8.Signed and dated informed consent indicating that the subject has been informed of all the pertinent aspects of the trial prior to enrollment

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 946
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Primary ovarian failure
2.Preimplantation genetic screening or diagnosis
3.Two episodes of POR after maximal stimulation
4.History or presence of tumors of the hypothalamus or pituitary gland
5.History or presence of ovarian enlargement or cyst of unknown etiology, or presence of an ovarian cyst > 25 mm on the day of randomization
6.Presence of endometriosis Grade III – IV, confirmed or suspected
7.Presence of uni- or bilateral hydrosalpinx
8.Abnormal gynecological bleeding of undetermined origin
9.Malformations of sexual organs incompatible with pregnancy
10.Contraindication to being pregnant and/or carrying a pregnancy to term
11.Currently pregnant

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the trial is to demonstrate superiority of Pergoveris® versus GONAL-f® in poor ovarian response (POR) patients.;Secondary Objective: Key secondary objectives will include assessment of other clinical variables that reflect the efficacy of ovarian stimulation and safety assessment of combination treatment with recombinant human follicle-stimulating hormone (r-hFSH) and recombinant human luteinizing r-hLH (Pergoveris®) as compared to r-hFSH (GONAL-f®)-only treatment.;Primary end point(s): Total number of retrieved oocytes. ;Timepoint(s) of evaluation of this end point: On/before day 113 (Visit 12)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Ongoing pregnancy rate (assessed on/before day 185 -Visit 16).<br>• Live birth rate (assessed on/before day 365 - Visit 17).<br>• Embryo implantation rate (determined on/before day 154 - Visit 15).<br>• Clinical pregnancy rate (determined on/before day 154 - Visit 15).<br>• Biochemical pregnancy rate (determined on/before day 132 - Visit 14).<br>;Timepoint(s) of evaluation of this end point: Visits 14 to 17 as described above