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-CZ
• Lead Sponsor: Merck KGaA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-13
• Last Update Posted: 14 September 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, antimullerian
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