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

Phase 3CompletedNCT01956110

Ferring Pharmaceuticals1,329 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

1,329

Conditions

Infertility

Interventions

Follitropin Delta (FE 999049)DRUG

Follitropin Alfa (GONAL-F)DRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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.

Locations (13)

UZ Brussel (there may be other sites in this country)

Brussels, Belgium

Fertilitat and PUC-RS (there may be other sites in this country)

Porto Alegre, Brazil

Outcomes

Primary Outcomes

Ongoing Pregnancy Rate

Ongoing pregnancy was defined as at least one intrauterine viable fetus 10-11 weeks after blastocyst transfer.

Time frame: 10-11 weeks after blastocyst transfer

Ongoing Implantation Rate

Ongoing implantation rate was defined as the number of intrauterine viable fetuses 10-11 weeks after transfer divided by number of blastocysts transferred.

Time frame: 10-11 weeks after blastocyst transfer

Secondary Outcomes

Vital Pregnancy Rate

Vital pregnancy was defined as at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after blastocyst transfer.

Time frame: 5-6 weeks after blastocyst transfer

Implantation Rate

Implantation rate was defined as the number of gestational sacs 5-6 weeks after transfer divided by number of blastocysts transferred.

Time frame: 5-6 weeks after blastocyst transfer

Proportion of Subjects With Extreme Ovarian Responses, Defined as <4, ≥15 or ≥20 Oocytes Retrieved

Time frame: Day of oocyte retrieval

Proportion of Subjects With Early OHSS (Ovarian Hyperstimulation Syndrome) and/or Preventive Interventions for Early OHSS

The proportion of subjects with early OHSS, early OHSS of moderate or severe grade, preventive interventions for early OHSS, early OHSS and/or preventive interventions for early OHSS, and early OHSS of moderate or severe grade and/or preventive interventions for early OHSS are presented.

Time frame: ≤9 days after triggering of final follicular maturation

Proportion of Subjects With Cycle Cancellation Due to Poor Ovarian Response or Excessive Ovarian Response

Data from ClinicalTrials.gov

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