Evidence-based Stimulation Trial With Human rFSH in Europe and Rest of World 1 (ESTHER-1)

Ferring

Status and phase

Completed

Phase 3

Conditions

Infertility

Treatments

Drug: Follitropin Alfa (GONAL-F)

Drug: Follitropin Delta (FE 999049)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01956110

U1111-1147-6826 (Other Identifier)

2013-001669-17 (EudraCT Number)

000004

Details and patient eligibility

About

This trial investigates the effects of FE 999049 compared to GONAL-F.

Enrollment

1,329 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Informed Consent Documents signed prior to screening evaluations
In good physical and mental health
Pre-menopausal females between the ages of 18 and 40 years
Infertile women diagnosed with tubal infertility, unexplained infertility, endometriosis stage I/II or with partners diagnosed with male factor infertility, eligible for in vitro fertilisation (IVF) and/or intracytoplasmic sperm injection (ICSI) using fresh or frozen ejaculated sperm from male partner or sperm donor
Infertility for at least one year before randomisation for subjects ≤37 years or for at least 6 months for subjects ≥38 years (not applicable in case of tubal or severe male factor infertility)
The trial cycle will be the subject's first controlled ovarian stimulation cycle for IVF/ICSI
Hysterosalpingography, hysteroscopy, saline infusion sonography, or transvaginal ultrasound documenting a uterus consistent with expected normal function (e.g. no evidence of clinically interfering uterine fibroids defined as submucous or intramural fibroids larger than 3 cm in diameter, no polyps and no congenital structural abnormalities which are associated with a reduced chance of pregnancy) within 1 year prior to randomisation
Transvaginal ultrasound documenting presence and adequate visualisation of both ovaries, without evidence of significant abnormality (e.g. no endometrioma greater than 3 cm or enlarged ovaries which would contraindicate the use of gonadotropins) and normal adnexa (e.g. no hydrosalpinx) within 1 year prior to randomisation. Both ovaries must be accessible for oocyte retrieval.
Early follicular phase (cycle day 2-4) serum levels of FSH between 1 and 15 IU/L (results obtained within 3 months prior to randomisation)
Body mass index (BMI) between 17.5 and 32.0 kg/m2 (both inclusive) at screening

Exclusion criteria

Known endometriosis stage III-IV
One or more follicles ≥10 mm observed on the transvaginal ultrasound prior to randomisation on stimulation day 1
Known history of recurrent miscarriage (defined as three consecutive losses after ultrasound confirmation of pregnancy (excl. ectopic pregnancy) and before week 24 of pregnancy)
Known abnormal karyotype of subject or of her partner/sperm donor, as applicable, depending on source of sperm used for insemination in this trial.
Any known clinically significant systemic disease (e.g. insulin-dependent diabetes)
Any known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) which can compromise participation in the trial with the exception of controlled thyroid function disease
Known tumours of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus which would contraindicate the use of gonadotropins.