Follitropin Delta in Long GnRH Agonist and GnRH Antagonist Protocols (BEYOND)

Ferring Pharmaceuticals437 enrolled

Overview

To compare the efficacy and safety of FE 999049 (follitropin delta) and its personalized dosing algorithm in controlled ovarian stimulation for in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) using a long gonadotropin-releasing hormone (GnRH) agonist protocol versus a short GnRH antagonist protocol.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

437

Conditions

Infertility, Female

Interventions

FE 999049 + GnRH agonist (GONAPEPTYL)DRUG

Pre-filled injection pen

FE 999049 + GnRH antagonist (CETROTIDE)DRUG

Powder and solvent for solution for injection

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Infertile women aged 18-40 undergoing their first IVF/ICSI cycle that are in good physical and mental health and that have been diagnosed with problems in the fallopian tubes, mild endometriosis or have partners with decreased sperm quality. * The participants must have a regular menstrual cycle, a normal uterus and 2 normal ovaries. * The allowed body mass index is 17.5-32 Kg/m\^2. Exclusion Criteria: * Women with very high ovarian reserve, strong preference for either treatment, severe endometriosis, history of repeated miscarriage, couples with known problems in the chromosomes, history or high risk of producing blood cloths, women known to have chronic diseases, women recently participating in trials with non-registered drugs.

Locations (16)

Das Kinderwunsch Institut Schenk GmbH

Dobl, Austria

Kepler University Hospital Linz

Linz, Austria

Kinderwunschzentrum Goldenes Kreuz Privatklinik

Vienna, Austria

Outcomes

Primary Outcomes

Number of Oocytes Retrieved

The number of oocytes retrieved was recorded at the oocyte retrieval visit.

Time frame: On day of oocyte retrieval (up to 22 days after start of stimulation)

Secondary Outcomes

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

For each participant, the reason for cycle cancellation was recorded

Time frame: At end-of-stimulation (up to 20 days)

Proportion of Subjects With Blastocyst Transfer Cancellation After Oocyte Retrieval Due to (Risk of) Ovarian Hyperstimulation Syndrome (OHSS)

For each participant, the reason for blastocyst transfer cancellation was recorded.

Time frame: At end of transfer (up to 4 weeks)

Number of Follicles

The total number of follicles and the number of follicles per size category will be reported

Time frame: On stimulation day 6 and at end-of-stimulation (up to 20 days)

Proportion of Subjects With <4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved

Grouped according to number of oocytes

Time frame: On day of oocyte retrieval (up to 22 days after start of stimulation)

Number of Metaphase II Oocytes

Only applicable for those inseminated using ICSI

Time frame: On day of oocyte retrieval (up to 22 days after start of stimulation)

Fertilization Rate

Measured by the number of pronuclei. Fertilized oocytes with 2 pronuclei were regarded as correctly fertilized

Data from ClinicalTrials.gov

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Rigshospitalet

Copenhagen, Denmark

Hillel Yafe Medical Center

Hadera, Israel

Shaare Zedek Medical Center

Jerusalem, Israel

Beilinson Hospital Rabin Medical Center

Petah Tikva, Israel

Sourasky Medical Center

Tel Aviv, Israel

Dipartimento della Donna, del bambino e delle malattie urologiche

Bologna, Italy

European Hospital

Roma, Italy

...and 6 more locations

Time frame: On day 1 after oocyte retrieval (up to 23 days after start of stimulation)

Number of Embryos

The number of embryos (total and good-quality) was reported. Embryo quality is determined by combined assessment of cleavage stage (number of blastomeres/compaction status) and embryo morphology parameters

Time frame: On day 3 after oocyte retrieval (up to 25 days after start of stimulation)

Number of Blastocysts

The number of blastocysts (total and good-quality) was reported. Blastocyst quality is assessed by blastocyst expansion and hatching status, blastocyst inner cell mass grading, and trophectoderm grading. The scoring is based on the classification system by Gardner and Schoolcraft, with additional categories for inner cell mass (degenerative or no inner cell mass) and trophectoderm (degenerative or very large cells)

Time frame: On day 5 after oocyte retrieval (up to 27 days after start of stimulation)

Circulating Concentrations of Follicle-stimulating Hormone (FSH)

Blood samples for analysis of circulating concentrations of FSH were drawn.