InfertilityNCT01196143
A Study to Evaluate the Baseline Follicle Stimulating Hormone, Ovarian Volume and Antral Follicle Count as Prognostic Factors of the Outcome of In-vitro Fertilisation/Intracytosolic Sperm Injection in Infertile Patients Receiving Gonal f for Controlled Ovarian Hyperstimulation
An observational study of Infertility, run by Merck KGaA, Darmstadt, Germany at 1 site in Greece.
Trial summary
This is a phase IV non-interventional, multicentric observational study to evaluate the baseline follicle stimulating hormone (FSH) levels, ovarian volume, antral follicle count (AFC) and age as prognostic factors of the outcome of the in-vitro fertilisation/intracytosolic sperm injection (IVF/ICSI) in infertile… Read more about this study
- Who is it for?
- Ages 20 to 43 years, women only
- Conditions the study is for
- Infertility
- How many people
- 356 participants
- Where
- 1 siteGreece
- Study dates
- Oct 2008to Jan 2011
- 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 20 to 43 years
- Women only
- No healthy volunteers
- Adult
Study population: Subjects undergoing COH for IVF/ICSI-treatment with Gonal-f in Greece.
Who may be able to join
- Pre-menopausal female subjects aged between 20-43 years
- Subjects requiring treatment with recombinant FSH for COH for IVF and/or ICSI
- Subjects who are able to communicate well with the investigator and can comply with the requirements of the entire study
- Subjects who have given written informed consent, prior to treatment, with the understanding that consent may be withdrawn by the subject at any time without prejudice
Who cannot join
- Female subjects not pregnant or lactating
- Subjects with known allergic reaction against one of the ingredients
- Subjects with enlarged ovaries or cysts unrelated to polycystic ovarian disease.
- Subjects with gynaecological bleeding of unknown origin
- Subjects with ovarian, uterine, or mammary cancer
- Subjects with hyperprolactinaemia
- Subjects with tumors of the hypothalamus or the pituitary gland
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-interventional Observational Study to Evaluate the Baseline FSH, Ovarian Volume and AFC (Antral Follicle Count) as Prognostic Factors of the Outcome of the In-vitro Fertilization/Intracytosolic Sperm Injection (IVF/ICSI) in Infertile Patients Who Receive r-FSH (GONAL-f®) for Controlled Ovarian Hyperstimulation
This is a phase IV non-interventional, multicentric observational study to evaluate the baseline follicle stimulating hormone (FSH) levels, ovarian volume, antral follicle count (AFC) and age as prognostic factors of the outcome of the in-vitro fertilisation/intracytosolic sperm injection (IVF/ICSI) in infertile subjects receiving Gonal-f for controlled ovarian hyperstimulation (COH).
Read the detailed description
Treatment of subfertility and infertility by assisted reproduction technologies (ART) such as IVF and embryo transfer (ET) requires multiple follicular development to increase the number of female gametes, and the chances of a successful treatment outcome. These technologies include the stimulation of multiple follicular development by exogenous FSH administration and the suppression of endogenous luteinizing hormone (LH) secretion by administration of a GnRH analogue (antagonist or agonist, as required). A single dose of human chorionic gonadotropin (hCG) is administered to mimic the endogenous LH surge and induce final oocyte maturation after adequate follicular development. Recombinant-hFSH (r-hFSH) has been shown to be efficacious in terms of number of oocytes recovered and in terms of pregnancy rates as compared to urinary-hFSH.
Gonal-f fill-by-mass is available as a liquid formulation that can be administered with the pen device. The pen device is prefilled and hence the subject does not require to assemble the device making it simpler to use. The prefilled pen allows the accurate delivery of a precise dose of r-hFSH in 37.5 International Units (IU) increments.
OBJECTIVES
Primary objective:
- Evaluation of the significance of baseline FSH, ovarian volume and AFC with a model adjusted for age as prognostic factors of the IVF/ICSI treatment outcome.
This study planned to enrol 500 female subjects undergoing COH for IVF/ICSI-treatment with Gonal-f. Gonal-f will be administered daily subcutaneously (s.c.) according to the centre's usual clinical practice, commencing on Days 2 or 3 of the cycle during the stimulation period. Treatment with Gonal-f will be continued until adequate follicular development has been achieved with the dose adjusted according to the subject's response, to usually not higher than 450 IU daily. A single injection of 250 micrograms r-hCG or 5,000 IU up to 10,000 IU hCG would be administered 24-48 hours after the last Gonal-f injection to induce final follicular maturation. Gonal-f will be started approximately 2 weeks after the start of an gonadotrophin-releasing hormone (GnRH) agonist treatment, both being continued until adequate follicular development will be achieved. Oocyte retrieval will be done 34-36 hours after hCG administration followed by IVF/ICSI treatment according to clinic's protocol. Each enrolled subject would be followed up until the confirmation of her pregnancy status. Active follow up of all pregnancies will be performed, including those subjects withdrawn from the study.
- Conditions
- Infertility
- Keywords
- Ovulation induction, Intrauterine insemination, Gonal-f, Controlled ovarian stimulation, Female infertility
- Medical subject headings
- Infertility, Infertility, Female
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate
Measured: Up to 28 days after birth
Secondary outcomes (9)
Pregnancy rate (ongoing, clinical, biochemical)
Biochemical: up to 2 weeks post embryo-transfer / clinical: up to 12 weeks post embryo-transfer / ongoing: up to 40 weeks post embryo-transfer
Measured: up to 40 weeks post embryo-transfer
Fertilization rate
Measured: 24 hours post oocyte retrieval
Implantation rate
Measured: 2 weeks post embryo-transfer
Detailed record of adverse events
Measured: Up to 1 year after subject enrollment
Hormone (E2) levels on hCG day
Measured: Up to 12 hours prior to hCG administration
Duration of treatment
Measured: Up to 12 hours post last FSH injection
Total amount of FSH administered
Measured: Up to 1 hour post last FSH injection
Number of oocytes
Measured: Up to 1 hour post oocyte retrieval
Miscarriage rate
Measured: Up to 12 weeks post embryo-transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2010 (estimated)
- Study startOct 2008
- Primary completionJan 2011
- Study completionJan 2011
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michalis Arvanitis, MD, MSc, Study director, Merck A.E. Hellas,Greece, an affiliate of MerckKGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01196143
- Sponsor's protocol ID
- 700623-503
- Status last verified
- Feb 2014
- First submitted
- 19 Apr 2010
- Last updated
- 4 Feb 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Observational Study to Evaluate the Baseline FSH, Ovarian Volume and AFC (Antral Follicle Count) as Prognostic Factors of the Outcome of the In-vitro Fertilization/Intracytosolic Sperm Injection (IVF/ICSI) in Infertile Patients Who Receive r-FSH (GONAL-f®) for Controlled Ovarian Hyperstimulation
- ClinicalTrials.gov ID
- NCT01196143
- Acronym / sponsor ID
- 700623-503
- Conditions
- Infertility
- Keywords
- Ovulation induction, Intrauterine insemination, Gonal-f, Controlled ovarian stimulation, Female infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 8 Sep 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 phase IV non-interventional, multicentric observational study to evaluate the baseline follicle stimulating hormone (FSH) levels, ovarian volume, antral follicle count (AFC) and age as prognostic factors of the outcome of the in-vitro fertilisation/intracytosolic sperm injection (IVF/ICSI) in infertile subjects receiving Gonal-f for controlled ovarian hyperstimulation (COH).
Detailed description
Treatment of subfertility and infertility by assisted reproduction technologies (ART) such as IVF and embryo transfer (ET) requires multiple follicular development to increase the number of female gametes, and the chances of a successful treatment outcome. These technologies include the stimulation of multiple follicular development by exogenous FSH administration and the suppression of endogenous luteinizing hormone (LH) secretion by administration of a GnRH analogue (antagonist or agonist, as required). A single dose of human chorionic gonadotropin (hCG) is administered to mimic the endogenous LH surge and induce final oocyte maturation after adequate follicular development. Recombinant-hFSH (r-hFSH) has been shown to be efficacious in terms of number of oocytes recovered and in terms of pregnancy rates as compared to urinary-hFSH.
Gonal-f fill-by-mass is available as a liquid formulation that can be administered with the pen device. The pen device is prefilled and hence the subject does not require to assemble the device making it simpler to use. The prefilled pen allows the accurate delivery of a precise dose of r-hFSH in 37.5 International Units (IU) increments.
OBJECTIVES
Primary objective:
- Evaluation of the significance of baseline FSH, ovarian volume and AFC with a model adjusted for age as prognostic factors of the IVF/ICSI treatment outcome.
This study planned to enrol 500 female subjects undergoing COH for IVF/ICSI-treatment with Gonal-f. Gonal-f will be administered daily subcutaneously (s.c.) according to the centre's usual clinical practice, commencing on Days 2 or 3 of the cycle during the stimulation period. Treatment with Gonal-f will be continued until adequate follicular development has been achieved with the dose adjusted according to the subject's response, to usually not higher than 450 IU daily. A single injection of 250 micrograms r-hCG or 5,000 IU up to 10,000 IU hCG would be administered 24-48 hours after the last Gonal-f injection to induce final follicular maturation. Gonal-f will be started approximately 2 weeks after the start of an gonadotrophin-releasing hormone (GnRH) agonist treatment, both being continued until adequate follicular development will be achieved. Oocyte retrieval will be done 34-36 hours after hCG administration followed by IVF/ICSI treatment according to clinic's protocol. Each enrolled subject would be followed up until the confirmation of her pregnancy status. Active follow up of all pregnancies will be performed, including those subjects withdrawn from the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Subjects undergoing COH for IVF/ICSI-treatment with Gonal-f in Greece.
Key inclusion criteria (4 listed)
- Pre-menopausal female subjects aged between 20-43 years
- Subjects requiring treatment with recombinant FSH for COH for IVF and/or ICSI
- Subjects who are able to communicate well with the investigator and can comply with the requirements of the entire study
- Subjects who have given written informed consent, prior to treatment, with the understanding that consent may be withdrawn by the subject at any time without prejudice
Key exclusion criteria (7 listed)
- Female subjects not pregnant or lactating
- Subjects with known allergic reaction against one of the ingredients
- Subjects with enlarged ovaries or cysts unrelated to polycystic ovarian disease.
- Subjects with gynaecological bleeding of unknown origin
- Subjects with ovarian, uterine, or mammary cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Live birth rate
Time frame: Up to 28 days after birth
9 secondary outcomes
Pregnancy rate (ongoing, clinical, biochemical)
Time frame: up to 40 weeks post embryo-transfer
Fertilization rate
Time frame: 24 hours post oocyte retrieval
Implantation rate
Time frame: 2 weeks post embryo-transfer
Detailed record of adverse events
Time frame: Up to 1 year after subject enrollment
Hormone (E2) levels on hCG day
Time frame: Up to 12 hours prior to hCG administration
Duration of treatment
Time frame: Up to 12 hours post last FSH injection
Total amount of FSH administered
Time frame: Up to 1 hour post last FSH injection
Number of oocytes
Time frame: Up to 1 hour post oocyte retrieval
Miscarriage rate
Time frame: Up to 12 weeks post embryo-transfer
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 4 Feb 2014.
Related trials for Infertility
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
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.
Michalis Arvanitis, MD, MSc study director
Merck A.E. Hellas,Greece, an affiliate of MerckKGaA, Darmstadt, Germany
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 Greece.
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 7 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 4 Feb 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 Greece. 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?
Live birth rate (time frame: Up to 28 days after birth). 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 4 Feb 2014.