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 folliclesMedDRA version: 16.1Level: LLTClassification code 10033140Term: Ovarian disorder NOSSystem Organ Class: 100000004872Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]
- Registration Number
- EUCTR2013-003817-16-ES
- Lead Sponsor
- Merck KGaA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 946
The current trial will enroll poor ovarian responders according to specific criteria that are aligned with the POR criteria defined by ESHRE.
At least 2 of the following 3 features must be present:
- Advanced maternal age (? 40 years)
- A previous POR (? 3 oocytes with a conventional stimulation protocol)
- An abnormal ovarian reserve test (ORT) (ie, anti-mullerian hormone [AMH] < 0.5 - 1.1 ng mL)
Additional inclusion criteria are:
1. 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
2. Absence of anatomical abnormalities of the reproductive tract that would interfere with implantation or pregnancy
3. Absence of any medical condition in which pregnancy is contraindicated
4. Body mass index 18 to 30 kg/m2, inclusive
5. Motile, ejaculatory sperm must be available (donated and/or cryopreserved sperm is allowed). Intracytoplasmic sperm injection will be allowed during this trial.
6. Minimum of 1 month without treatment with either clomiphene citrate or gonadotrophins prior to screening
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
1. Two episodes of POR after maximal stimulation
2. History or presence of tumors of the hypothalamus or pituitary gland
3. History or presence of ovarian enlargement or cyst of unknown etiology, or presence of an ovarian cyst > 25 mm on the day of randomization
4. Presence of endometriosis grade III ? IV, confirmed or suspected
5. Presence of uni- or bilateral hydrosalpinx
6. Abnormal gynecological bleeding of undetermined origin
7. Contraindication to being pregnant and/or carrying a pregnancy to term
8. History or presence of ovarian, uterine or mammary cancer
9. Use of testicular or epididymal sperm
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method