Current partner codePEPTIDESDE
NCT03809429·Phase 3·INTERVENTIONAL

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

Status

Completed

Phase

Phase 3

Enrollment

437

Locations

16

Results

Posted

Publications

1

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

FE 999049 + GnRH agonist (GONAPEPTYL)

Pre-filled injection pen

DRUG

FE 999049 + GnRH antagonist (CETROTIDE)

Powder and solvent for solution for injection

Timeline

From registration to results.

  1. First posted

    Jan 18, 2019

  2. Study start

    Apr 29, 2019

  3. Primary completion

    Feb 16, 2022

  4. Study completion

    Feb 16, 2022

  5. Results posted

    May 13, 2024

  6. Registry updated

    May 13, 2024

Outcomes

What the study measures.

Primary outcomes

Number of Oocytes Retrieved

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

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

Secondary outcomes

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

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

For each participant, the reason for cycle cancellation was recorded

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

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

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

Number of Follicles

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

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

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

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

Grouped according to number of oocytes

Number of Metaphase II Oocytes

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

Only applicable for those inseminated using ICSI

Fertilization Rate

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

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

Number of Embryos

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

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

Number of Blastocysts

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

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)

Circulating Concentrations of Follicle-stimulating Hormone (FSH)

Time frame · On stimulation day 6, at end-of-stimulation (up to 20 days after start of stimulation) and at oocyte retrieval (up to 22 days after start of stimulation)

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

Circulating Concentrations of Luteinizing Hormone (LH)

Time frame · On stimulation day 6, at end-of-stimulation (up to 20 days after start of stimulation) and at oocyte retrieval (up to 22 days after start of stimulation)

Blood samples for analysis of circulating concentrations of LH were drawn

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
40 Years
Sex
FEMALE
Healthy volunteers
No

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.

Study locations

16 registered sites.

Austria · Denmark · Israel · Italy · Netherlands · Norway · Switzerland. Showing up to 24 locations stored in the fast local snapshot.

Das Kinderwunsch Institut Schenk GmbH

Dobl, Austria

Kepler University Hospital Linz

Linz, Austria

Kinderwunschzentrum Goldenes Kreuz Privatklinik

Vienna, Austria

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

St. Elisabeth Ziekenhuis

Tilburg, Netherlands

Isala Fertility Center

Zwolle, Netherlands

Oslo University Hospital

Oslo, Norway

Sykehuset Telemark HF

Porsgrunn, Norway

Medicus AS

Trondheim, Norway

Gyn-A.R.T. AG

Zurich, Switzerland

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More studies on Cetrorelix.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.