InfertilityNCT01109654
An Observational Study of Cetrotide® Gonadotropin-releasing Hormone Antagonist (GnRH Antagonist) With GONAL-f® in Assisted Reproductive Technologies (ART)
An observational study of Infertility, run by Merck KGaA, Darmstadt, Germany at 1 site in Singapore.
Trial summary
This is a multicentric, prospective, observational study on the use of Cetrotide to control the endogenous gonadotrophin levels in Gonal-f stimulated ART treatment cycles in the Asia-Pacific region. The study plans to enrol approximately 1800-2000 subjects over a 9-month period at each participating centre. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Cetrorelix acetate and Follitropin alfa
- Type of treatment
- Injection or infusion
- How many people
- 2,175 participants
- Where
- 1 siteSingapore
- Study dates
- Sep 2008to Dec 2010
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Female subjects undergoing controlled ovarian stimulation.
Who may be able to join
- Subjects who are undergoing ovarian stimulation for IVF or ICSI therapy
- Decision by treating physician to prescribe Gonal-f for controlled ovarian stimulation prior to study enrolment
- Decision by treating physician to prescribe Cetrotide as the down-regulation agent prior to study enrolment
Who cannot join
- Subjects using GnRH agonist as the down-regulation agent
- Contraindicated use of Cetrotide based on local label
- Subjects who have participated in the study previously
- Subjects with hypersensitivity to cetrorelix acetate, extrinsic peptide hormones or mannitol
- Subjects with known hypersensitivity to GnRH or any other GnRH analogs
- Subjects with known or suspected pregnancy, and lactation
Trial locations and contacts
1 site in 1 country.
Singapore1 site
Singapore General Hospital Pte Ltd, Outram Road
Singapore, 609927
About this study
Official title: A Prospective, Observational Study on the Use of Cetrotide (GnRH Antagonist) With GONAL-f in Assisted Reproductive Technologies (ART)
This is a multicentric, prospective, observational study on the use of Cetrotide to control the endogenous gonadotrophin levels in Gonal-f stimulated ART treatment cycles in the Asia-Pacific region. The study plans to enrol approximately 1800-2000 subjects over a 9-month period at each participating centre.
This observational study is initiated to collect information on the use of Cetrotide (GnRH antagonist) in ART cycles in routine practice across the Asia-Pacific region. The information will allow a better understanding of the current ovarian stimulation regimens that involve Cetrotide in the control of the endogenous gonadotrophin concentrations. The collection of live birth data, though a challenging task, as a secondary endpoint will allow the study to show valuable information on the final objective of ART. To minimize the potential variability due to the different ovarian stimulation agents, the study is to include cycles treated with Gonal-f (recombinant human FSH) since this agent is widely available in the region.
Read the detailed description
Gonadotrophin-releasing hormone (GnRH) antagonists were introduced in the beginning of this decade for the use in ART. The potential advantages of GnRH antagonists over the GnRH agonists include the avoidance of an acute stimulation of endogenous gonadotrophins and a dramatic reduction in the length of analogue treatment.
Despite the plus points of GnRH antagonists in ART, there has been some concern over the lower pregnancy rate reported, which may be the cause of a lower acceptance of GnRH antagonists in ovarian stimulation for in vitro fertilization (IVF). Interestingly, a separate meta-analysis did not reach the same finding. The probability of live birth after ovarian stimulation for IVF was found not to be dependent on the type of analogue used for pituitary suppression Cetrotide, a GnRH antagonist from Merck Serono, is currently approved for the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian stimulation in majority of the regions. It is given either as a single-dose regimen of 3 mg injection or as a multiple-dose regimen of 0.25 mg daily injection. Both regimens have been shown to offer equivalent efficacy and safety outcomes.
OBJECTIVES:
Primary objective:
- To assess the effectiveness of Cetrotide regimens, when used with Gonal-f, in routine ART treatment cycles
Secondary objectives:
- To assess the effectiveness of Cetrotide regimens on other efficacy endpoints
- To survey the types of Cetrotide regimen used and their success rates
- To assess the safety of Cetrotide regimens
- To explore the association between subject characteristics and treatment outcomes
- Conditions
- Infertility
- Being tested
- Cetrorelix acetate and Follitropin alfa
- Keywords
- Fertilization in Vitro, Reproductive Techniques, Assisted, Follicle Stimulating Hormone, Cetrotide, Gonal-f
- Medical subject headings
- Infertility, Helping Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetrorelix acetate and Follitropin alfaDrug
Also called Cetrotide, Gonal-f
Cetrorelix acetate given either as a single-dose regimen of 3 mg injection or as a multiple-dose regimen of 0.25 mg daily injection.Ovarian stimulation therapy with Follitropin alfa generally starts on cycle Day 2 or 3. The starting dose of Follitropin alfa is based on the Investigators' discretion
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects achieving a clinical pregnancy.
A transvaginal ultrasound scan will be performed on all subjects who become pregnant provided that no miscarriage has occurred.
Measured: At post hCG days 35-42
Secondary outcomes (10)
Proportion of subjects with cancelled cycles
Measured: 3 month
Proportion of women with OHSS or risk of OHSS
Measured: 3 month
Duration and dose of Cetrotide administered
Measured: 3 month
Assessment of baseline characteristics
Assessment of subjects age, weight, height, FSH and LH level prior to Gonal-f administration, concomitant treatment, infertility history and infertility treatment
Measured: 3 month
Total dose of Gonal-f administered
Measured: 3 month
Duration of ovarian stimulation
Measured: 3 month
Number of oocytes retrieved
Measured: 3 month
Number of subjects with Adverse Events
Measured: 3 month
Pregnancy rate
Measured: 12 month
Live birth rate
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2010 (estimated)
- Study startSep 2008
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Pte. Ltd., Singapore
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Pte. Ltd., Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01109654
- Sponsor's protocol ID
- EMR200088-500
- Status last verified
- Jan 2012
- First submitted
- 22 Apr 2010
- Last updated
- 16 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational Study on the Use of Cetrotide (GnRH Antagonist) With GONAL-f in Assisted Reproductive Technologies (ART)
- ClinicalTrials.gov ID
- NCT01109654
- Acronym / sponsor ID
- EMR200088-500
- Conditions
- Infertility
- Keywords
- Fertilization in Vitro, Reproductive Techniques, Assisted, Follicle Stimulating Hormone, Cetrotide, Gonal-f
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,175 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Collaborators
- Merck Pte. Ltd., Singapore
- Study start
- Sep 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 23 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicentric, prospective, observational study on the use of Cetrotide to control the endogenous gonadotrophin levels in Gonal-f stimulated ART treatment cycles in the Asia-Pacific region. The study plans to enrol approximately 1800-2000 subjects over a 9-month period at each participating centre.
This observational study is initiated to collect information on the use of Cetrotide (GnRH antagonist) in ART cycles in routine practice across the Asia-Pacific region. The information will allow a better understanding of the current ovarian stimulation regimens that involve Cetrotide in the control of the endogenous gonadotrophin concentrations. The collection of live birth data, though a challenging task, as a secondary endpoint will allow the study to show valuable information on the final objective of ART. To minimize the potential variability due to the different ovarian stimulation agents, the study is to include cycles treated with Gonal-f (recombinant human FSH) since this agent is widely available in the region.
Detailed description
Gonadotrophin-releasing hormone (GnRH) antagonists were introduced in the beginning of this decade for the use in ART. The potential advantages of GnRH antagonists over the GnRH agonists include the avoidance of an acute stimulation of endogenous gonadotrophins and a dramatic reduction in the length of analogue treatment.
Despite the plus points of GnRH antagonists in ART, there has been some concern over the lower pregnancy rate reported, which may be the cause of a lower acceptance of GnRH antagonists in ovarian stimulation for in vitro fertilization (IVF). Interestingly, a separate meta-analysis did not reach the same finding. The probability of live birth after ovarian stimulation for IVF was found not to be dependent on the type of analogue used for pituitary suppression Cetrotide, a GnRH antagonist from Merck Serono, is currently approved for the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian stimulation in majority of the regions. It is given either as a single-dose regimen of 3 mg injection or as a multiple-dose regimen of 0.25 mg daily injection. Both regimens have been shown to offer equivalent efficacy and safety outcomes.
OBJECTIVES:
Primary objective:
- To assess the effectiveness of Cetrotide regimens, when used with Gonal-f, in routine ART treatment cycles
Secondary objectives:
- To assess the effectiveness of Cetrotide regimens on other efficacy endpoints
- To survey the types of Cetrotide regimen used and their success rates
- To assess the safety of Cetrotide regimens
- To explore the association between subject characteristics and treatment outcomes
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Female subjects undergoing controlled ovarian stimulation.
Key inclusion criteria (3 listed)
- Subjects who are undergoing ovarian stimulation for IVF or ICSI therapy
- Decision by treating physician to prescribe Gonal-f for controlled ovarian stimulation prior to study enrolment
- Decision by treating physician to prescribe Cetrotide as the down-regulation agent prior to study enrolment
Key exclusion criteria (6 listed)
- Subjects using GnRH agonist as the down-regulation agent
- Contraindicated use of Cetrotide based on local label
- Subjects who have participated in the study previously
- Subjects with hypersensitivity to cetrorelix acetate, extrinsic peptide hormones or mannitol
- Subjects with known hypersensitivity to GnRH or any other GnRH analogs
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 |
|---|---|---|
| Cetrorelix acetate and Follitropin alfaAlso: Cetrotide, Gonal-fCetrorelix acetate given either as a single-dose regimen of 3 mg injection or as a multiple-dose regimen of 0.25 mg daily injection.Ovarian stimulation therapy with Follitropin alfa generally starts on cycle Day 2 or 3. The starting dose of Follitropin alfa is based on the Investigators' discretion | Drug | – |
Primary outcome
Proportion of subjects achieving a clinical pregnancy.
Time frame: At post hCG days 35-42
A transvaginal ultrasound scan will be performed on all subjects who become pregnant provided that no miscarriage has occurred.
10 secondary outcomes
Proportion of subjects with cancelled cycles
Time frame: 3 month
Proportion of women with OHSS or risk of OHSS
Time frame: 3 month
Duration and dose of Cetrotide administered
Time frame: 3 month
Assessment of baseline characteristics
Time frame: 3 month
Total dose of Gonal-f administered
Time frame: 3 month
Duration of ovarian stimulation
Time frame: 3 month
Number of oocytes retrieved
Time frame: 3 month
Number of subjects with Adverse Events
Time frame: 3 month
Pregnancy rate
Time frame: 12 month
Live birth rate
Time frame: 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2014.
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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.
Medical Director study director
Merck Pte. Ltd., Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Merck KGaA, Darmstadt, Germany at 1 site in Singapore.
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 3 inclusion and 6 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 16 Jul 2014. 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 Singapore. 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.
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?
Proportion of subjects achieving a clinical pregnancy. (time frame: At post hCG days 35-42). 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 16 Jul 2014.