InfertilityPhase 3FASHIONNCT02449889
A Randomised Trial Using Highly Purified Human Chorionic Gonadotropin (HP-hCG) and Recombinant Human Chorionic Gonadotropin (rhCG) in Women Undergoing Controlled Ovarian Stimulation
A Phase 3 study testing highly purified human chorionic gonadotropin and recombinant human chorionic gonadotropin in people with Infertility, run by Ferring Pharmaceuticals at 1 site in Brazil.
Trial summary
This trial is investigating the efficacy and safety of highly purified human chorionic gonadotropin (HP-hCG) and recombinant human chorionic gonadotropin (rhCG) for triggering of final follicular maturation in women undergoing controlled ovarian stimulation Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- highly purified human chorionic gonadotropin and recombinant human chorionic gonadotropin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2016to 1 Mar 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pre-menopausal females between the ages of 18 and 39 years
- Documented history of infertility
- Body mass index (BMI) between 17.5 and 32.0 kg/m2
- Regular menstrual cycles
Who cannot join
- Known endometriosis stage III and IV
- Known polycystic ovarian syndrome (PCOS)
- History of recurrent miscarriage
- History of more than three previous controlled ovarian stimulation cycles
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto Ideia Fértil de Saúde Reproductive (there may be other sites in this country)
São Paulo
About this study
Official title: A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre Trial Comparing the Efficacy and Safety of Highly Purified Human Chorionic Gonadotropin (HP-hCG) and Recombinant Human Chorionic Gonadotropin (rhCG) for Triggering of Final Follicular Maturation in Women Undergoing Controlled Ovarian Stimulation
This trial is investigating the efficacy and safety of highly purified human chorionic gonadotropin (HP-hCG) and recombinant human chorionic gonadotropin (rhCG) for triggering of final follicular maturation in women undergoing controlled ovarian stimulation
- Conditions
- Infertility
- Being tested
- highly purified human chorionic gonadotropin, recombinant human chorionic gonadotropin
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
highly purified human chorionic gonadotropinDrug
Also called CHORAPUR, BREVACTID
recombinant human chorionic gonadotropinDrug
Also called OVIDREL, OVITRELLE
| Study group | Role | What they receive |
|---|---|---|
| HP-hCG IM | Experimental | highly purified human chorionic gonadotropin, intramuscularly (IM) Receives: Drug: highly purified human chorionic gonadotropin |
| HP-hCG SC | Experimental | highly purified human chorionic gonadotropin, subcutaneously (SC) Receives: Drug: highly purified human chorionic gonadotropin |
| rhCG | Active comparator | recombinant human chorionic gonadotropin Receives: Drug: recombinant human chorionic gonadotropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Oocytes Retrieved
Oocyte retrieval took place 36 h (±2h) after hCG administration. At oocyte retrieval the number of oocytes retrieved was recorded.
Measured: Approximately 36 hours after hCG administration
Secondary outcomes (6)
Number of Metaphase II (MII) Oocytes
Only applicable for insemination using intracytoplasmic sperm injection (ICSI). The MII oocytes were counted prior to insemination.
Measured: Prior to insemination (within 6 hours after oocyte retrieval)
Number of Fertilized (2 Pronuclei (2PN)) Oocytes
Fertilization was assessed by counting the number of pronuclei, which was recorded as 0, 1, 2 or >2. Correct fertilization was defined as oocytes with 2PN.
Measured: One day after oocyte retrieval
Positive β Unit of Human Chorionic Gonadotropin (βhCG) Rate
Defined as percentage of subjects with positive beta hCG. A positive β hCG was confirmed by a blood test obtained 13-15 days after transfer.
Measured: 13-15 days after transfer
Clinical Pregnancy Rate
Defined as percentage of subjects with clinical pregnancy. Clinical pregnancy was defined as at least one gestational sac 5-6 weeks after transfer.
Measured: 5-6 weeks after transfer
Frequency of Adverse Events (AEs)
The number of treatment-emergent AEs (TEAEs) in each treatment group will be presented.
Measured: AEs were collected from signing informed consent until end of trial visit = maximum period approximately 5 months. However, only TEAEs are presented
Intensity of AEs
The intensity of an TEAE would be classified using the following 3-point scale: mild (awareness of signs or symptoms, but no disruption of usual activity), moderate (event sufficient to affect usual activity [disturbing]) or severe (inability to work or perform usual activities [unacceptable]).
Measured: AEs were collected from signing informed consent until end of trial visit = maximum period approximately 5 months. However, only TEAEs are presented.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2015 (estimated)
- Study startApr 2016
- Primary completion9 Jul 2017
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02449889
- Sponsor's protocol ID
- 000191
- Acronym
- FASHION
- Status last verified
- Jun 2019
- First submitted
- 18 May 2015
- Last updated
- 26 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre Trial Comparing the Efficacy and Safety of Highly Purified Human Chorionic Gonadotropin (HP-hCG) and Recombinant Human Chorionic Gonadotropin (rhCG) for Triggering of Final Follicular Maturation in Women Undergoing Controlled Ovarian Stimulation
- ClinicalTrials.gov ID
- NCT02449889
- Acronym / sponsor ID
- FASHION / 000191
- Conditions
- Infertility
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- 9 Jul 2017 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 20 May 2015 (estimated)
- Results
- Posted 10 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is investigating the efficacy and safety of highly purified human chorionic gonadotropin (HP-hCG) and recombinant human chorionic gonadotropin (rhCG) for triggering of final follicular maturation in women undergoing controlled ovarian stimulation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HP-hCG IM | Experimental | Drug: highly purified human chorionic gonadotropinhighly purified human chorionic gonadotropin, intramuscularly (IM) |
| HP-hCG SC | Experimental | Drug: highly purified human chorionic gonadotropinhighly purified human chorionic gonadotropin, subcutaneously (SC) |
| rhCG | Active comparator | Drug: recombinant human chorionic gonadotropinrecombinant human chorionic gonadotropin |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pre-menopausal females between the ages of 18 and 39 years
- Documented history of infertility
- Body mass index (BMI) between 17.5 and 32.0 kg/m2
- Regular menstrual cycles
Key exclusion criteria (4 listed)
- Known endometriosis stage III and IV
- Known polycystic ovarian syndrome (PCOS)
- History of recurrent miscarriage
- History of more than three previous controlled ovarian stimulation cycles
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| highly purified human chorionic gonadotropinAlso: CHORAPUR, BREVACTID | Drug | HP-hCG IM, HP-hCG SC |
| recombinant human chorionic gonadotropinAlso: OVIDREL, OVITRELLE | Drug | rhCG |
Primary outcome
Number of Oocytes Retrieved
Time frame: Approximately 36 hours after hCG administration
Oocyte retrieval took place 36 h (±2h) after hCG administration. At oocyte retrieval the number of oocytes retrieved was recorded.
6 secondary outcomes
Number of Metaphase II (MII) Oocytes
Time frame: Prior to insemination (within 6 hours after oocyte retrieval)
Number of Fertilized (2 Pronuclei (2PN)) Oocytes
Time frame: One day after oocyte retrieval
Positive β Unit of Human Chorionic Gonadotropin (βhCG) Rate
Time frame: 13-15 days after transfer
Clinical Pregnancy Rate
Time frame: 5-6 weeks after transfer
Frequency of Adverse Events (AEs)
Time frame: AEs were collected from signing informed consent until end of trial visit = maximum period approximately 5 months. However, only TEAEs are presented
Intensity of AEs
Time frame: AEs were collected from signing informed consent until end of trial visit = maximum period approximately 5 months. However, only TEAEs are presented.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Development Support study director
Ferring Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing highly purified human chorionic gonadotropin and recombinant human chorionic gonadotropin in people with Infertility, run by Ferring Pharmaceuticals at 1 site in Brazil.
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 4 inclusion and 4 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 26 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Oocytes Retrieved (time frame: Approximately 36 hours after hCG administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2019.