AzTrials
AzTrials

InfertilityPhase 2NCT01794208

Efficacy and Safety of FSH-GEX™ in Comparison With 150 IU Gonal-f®

A Phase 2 study testing Follitropin Epsilon and Follitropin Alfa in people with Infertility, run by Glycotope GmbH at 8 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The aim of the current study was the determination of the recommended standard treatment dose of FSH-GEX(TM) in women undergoing intracytoplasmic sperm injection (ICSI) treatment as assessed by follicle growth. Read more about this study

Who is it for?
Ages 18 to 37 years, women only
Conditions the study is for
Infertility
What is being tested?
Follitropin Epsilon and Follitropin Alfa
Could I receive a placebo?
No, everyone receives an active treatment
How many people
267 participants
Where
8 sitesin 2 countries
Study dates
8 Jan 2013to 30 Jul 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 37 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Female patient for whom ICSI treatment is justified
  • Serum follicle-stimulating hormone concentration
  • Anti-mullerian hormone concentration
  • Antral follicle count
  • Body mass index and body weight
  • Presence of both ovaries
Show all 10Show fewer
  • Regular spontaneous cycles between 21 and 35 days in length
  • Normal uterine cavity as assessed by transvaginal sonography at Screening
  • Willing and able to comply with the protocol
  • Willing and able to provide written informed consent

Who cannot join

  • Patients who had more than two unsuccessful previous assisted reproduction technology cycles before inclusion into the study
  • Previous poor responders
  • Patients with previous hyperstimulation syndrome or cycle cancellation because of imminent hyperstimulation syndrome
  • Patients with a history of or current polycystic ovarian morphology syndrome
  • Patients with a history of or current endometriosis III or IV
  • Presence of ovarian cyst at Screening
Show all 23Show fewer
  • Any contraindication to becoming pregnant
  • History of ≥ 3 clinical or preclinical miscarriages
  • Abnormal cervical smear, Papanicolaou [PAP] score ≥ 3
  • Any history of malignant cancer other than in situ breast or skin cancer requiring local excision
  • Any endocrine abnormalities requiring treatment
  • Any clinically significant systematic disease
  • Any known infection with human immunodeficiency virus, hepatitis B or C
  • History of thrombosis or other risk factors including any coagulation abnormality leading to an increased risk of clotting
  • Family history of genetic risk factors concerning pregnancy or birth
  • Use of concomitant medication, which in the opinion of the investigator might interfere with ICSI preparation procedures
  • Active smoking
  • Any active substance abuse of drugs, medications or alcohol within the last five years
  • Patients in an institution by official or court order
  • Patients who are unable or unwilling to provide informed consent
  • Any participation in another clinical trial within the last 60 days before randomisation
  • Previous FSH-GEX™ administration.
  • Known hypersensitivity to any component of the investigational and non investigational products used in this study

Trial locations and contacts

8 sites in 2 countries.

8 sites in 2 countries

Germany6 sites

  • Glycotope Investigational Site

    Berlin, 10117

  • Glycotope Investigational Site

    Berlin, 14050

  • Glycotope Investigational Medical Director

    Bielefeld, 33619

  • Glycotope Investigational Site

    Düsseldorf, 40219

  • Glycotope Investigational Site

    Heidelberg, 69115

  • Glycotope Investigational Site

    Lübeck, 23538

Other trials in Germany

Hungary2 sites

  • Glycotope Investigational Site

    Budapest, 1125

  • Glycotope Investigational Site

    Tapolca, 8300

Other trials in Hungary

About this study

Official title: A Phase II, Multicentre, Multinational, Randomised, Assessor-Blind Trial to Investigate the Efficacy and Safety of Various Dosages of FSH-GEX™ in Comparison With 150 IU Gonal-f® in Women Undergoing ICSI Treatment

The aim of the current study was the determination of the recommended standard treatment dose of FSH-GEX(TM) in women undergoing intracytoplasmic sperm injection (ICSI) treatment as assessed by follicle growth.

Read the detailed description

This was a phase II, randomized, assessor-blind, comparator-controlled, multiple dose study in women undergoing ICSI treatment.

The primary objective of the study was the determination of the recommended standard treatment dose of FSH-GEX™ as assessed by follicle growth dynamics in women between 18 and 37 years of age who were undergoing intracytoplasmic sperm injection treatment.

Conditions
Infertility
Being tested
Follitropin Epsilon, Follitropin Alfa
Keywords
in-vitro fertilization, reproductive disorder
Medical subject headings
Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Follitropin EpsilonDrug

    Also called FSH-GEX(TM)

  • Follitropin AlfaDrug

    Also called Gonal-f(R)

Study groups in NCT01794208
Study groupRoleWhat they receive
treatment 1ExperimentalFollitropin Epsilon 52.5 IU quaque die (QD) s.c.
Receives: Drug: Follitropin Epsilon
treatment 2ExperimentalFollitropin Epsilon 75 IU QD s.c.
Receives: Drug: Follitropin Epsilon
treatment 3ExperimentalFollitropin Epsilon 112.5 IU QD s.c.
Receives: Drug: Follitropin Epsilon
treatment 4ExperimentalFollitropin Epsilon 150 IU QD s.c.
Receives: Drug: Follitropin Epsilon
treatment 5ExperimentalFollitropin Epsilon 150 IU quaque altera die (QAD) s.c.
Receives: Drug: Follitropin Epsilon
treatment 6Active comparatorFollitropin alfa 150 IU QD s.c.
Receives: Drug: Follitropin Alfa

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of follicles

    The number of follicles with a diameter of ≥ 12 mm on the day of human chorionic gonadotropin (hCG) injection after stimulation with follicle stimulating hormone (FSH)

    Measured: day of hCG injection; variable timeframe; up to 18 days for maximum

Secondary outcomes (10)

  1. Follicular response

    For each ovary the number of follicles were classified and summarised as follows: mean diameter 8.0 - 9.9 mm, 10.0 - 11.9 mm, 12.0 - 13.9 mm, 14.0 - 15.9 mm, 16.0 - 17.9 mm, 18.0 - 19.9 mm, and >19.9 mm as determined by transvaginal ultrasonography

    Measured: every second day up to hCG injection; variable timeframe; up to 18 days for maximum

  2. Cumulus-oocyte-complexes

    Number of retrieved cumulus-oocyte-complexes

    Measured: at oocyte retrieval; 32 - 36 hours after hCG injection

  3. Oocytes retrieved

    Number of oocytes retrieved (metaphase II)

    Measured: at oocyte retrieval; 32 - 36 hours after hCG injection

  4. Two pronuclei oocytes

    Number of two pronuclei (2PN) oocytes one day after follicle puncture

    Measured: one day after oocyte retrieval

  5. Biochemical pregnancy rate

    Based on positive β-hCG pregnancy test

    Measured: 14 to 20 days after oocyte retrieval

  6. Clinical pregnancy rate

    Based on clinical or ultrasound parameters (gestational sac, foetal heart beat

    Measured: approx. 4 to 6 weeks after last FSH dose

  7. Implantation rate

    Number of foetal sacs on sonography divided by number of embryos transferred per embryo transfer

    Measured: approx. 4 to 6 weeks after last FSH dose

  8. Estradiol and inhibin B serum levels

    Concentration of Estradiol and Inhibin B in Serum after FSH stimulation

    Measured: every second day up to hCG injection; variable timeframe; up to 18 days maximum

  9. Adverse events, ovarian hyperstimulation syndrome, anti-drug-antibodies, overall tolerability

    Incidence of adverse events, ovarian hyperstimulation syndrome, anti-drug-antibodies, overall tolerability

    Measured: up to 4 to 6 weeks after last FSH dose

  10. Number of doses and total dose of FSH

    The total dose is the amount of FSH-GEX(TM) or Gonal-f® administered to each patient during the stimulation period

    Measured: variable timeframe; up to 18 days for maximum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2013 (estimated)
  2. Study start8 Jan 2013
  3. Primary completionJul 2013
  4. Study completion30 Jul 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
267 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01794208
Sponsor's protocol ID
GEXGP24201
Status last verified
May 2021
First submitted
23 Jan 2013
Last updated
7 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
Individual data sharing
No

Publications

  • Griesinger G, Dietrich B, Stockl L, Eckert K, Goletz S, Tandler-Schneider A. Fully human glyco-optimized recombinant FSH (follitropin epsilon) - a randomized, comparator-controlled phase II clinical trial. Reprod Biomed Online. 2020 Feb;40(2):331-341. doi: 10.1016/j.rbmo.2019.09.003. Epub 2019 Sep 16.

    PubMed 31982355

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Follitropin Epsilon and Follitropin Alfa in people with Infertility, run by Glycotope GmbH at 8 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Germany, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of follicles (time frame: day of hCG injection; variable timeframe; up to 18 days for maximum). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01794208, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in