Ovulation InductionP450NCT01111084
A Prospective, Multi-centric Observational Study to Determine the Mono-bifollicular Development in Infertile Women Subjected to Ovulation Induction With Follitropin α
An observational study of Ovulation Induction, run by Merck KGaA, Darmstadt, Germany at 1 site in Spain.
Trial summary
This is a prospective and multicentric observational study to determine the real mono-bifollicular development rate that is obtained under normal care conditions following ovulation induction (OI) treatment with follitropin-alpha filled by mass prescribed in accordance with standard practice. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ovulation Induction
- What is being tested?
- Follitropin alpha (r-FSH)
- How many people
- 410 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2004to Jun 2005
- 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 who were infertile due to anovulation undergoing OI treatment with follitropin alpha prescribed in accordance with the standard practice and in accordance with the technical specifications.
Who may be able to join
- Premenopausal women with infertility caused by anovulation, who wished to conceive and were included in an ovulation induction (OI) treatment protocol for intrauterine insemination or for programmed coitus
Who cannot join
- Subjects with hypersensitivity to follitropin alpha, to FSH or to any of the excipients
- Subjects with hypothalamic or pituitary tumours
- Subjects with increase in the size of the ovaries or cysts that were not due to polycystic ovary disease
- Subjects with gynaecologic haemorrhages of unknown aetiology
- Subjects with ovarian, uterine or mammary carcinoma
- Subjects with primary ovarian failure
- Subjects with malformations of sex organs that were not compatible with pregnancy
- Subjects with uterine fibroid tumours that were not compatible with pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Multi-centre Observational Study to Determine the Mono-bifollicular Development in Infertile Women Subjected to Ovulation Induction With Follitropin α
This is a prospective and multicentric observational study to determine the real mono-bifollicular development rate that is obtained under normal care conditions following ovulation induction (OI) treatment with follitropin-alpha filled by mass prescribed in accordance with standard practice.
Read the detailed description
In women with infertility due to anovulation, the main purpose of ovulation induction (OI) consists in inducing the mono or bifollicular and the subsequent ovulation in order to achieve pregnancy. The availability of recombinant gonadotropins obtained using genetically engineered techniques has meant a decisive and clear pharmacological advancement. Use of recombinant human follicle stimulating hormone (r-hFSH) offers a greater effectiveness (greater number of follicles/ ovocytes and a higher pregnancy rate) and efficiency (fewer number of blisters, fewer stimulation days; fewer number of cancellations and complications) in programmed coitus and artificial insemination like in-vitro fertilisation (IVF)/intra cytoplasmic sperm injection (ICSI) techniques. Further advances in obtaining better products for ovarian stimulation has led to production of a recombinant FSH (follitropin alpha) filled by mass preparation. This hormone becomes the most consistent and precise gonadotropin due to improvements in its quantification process.
Today, despite having accurate and modern tools for ovulation induction, in daily practice, doctors continue to "fight" against two old problems of assisted reproduction: multiple pregnancies and ovarian hyperstimulation syndrome (OHSS). Application of assisted reproduction techniques (ARTs) and the use of medication that induce ovulation, risk producing gestations and multiple births with a higher frequency than those observed in spontaneous gestations. One of the facts that result in the appearance of such problems is the high incidence of polycystic ovarian syndrome among the population of women who are infertile due to anovulation. These subjects are especially sensitive to ovarian stimulation, which leads to multiple follicular development, a higher risk of hyperstimulation and higher rates of multiple pregnancies.
Therefore, it seems clear that the search for developing mono or bifollicular cycles is important in ovarian induction cycles, for the purpose of preventing the above mentioned multiple pregnancy problems and the risk of OHSS. The intent of this study was to figure out the real mono-bifollicular development rate that is obtained under normal care conditions following OI treatment with follitropin alpha filled by mass prescribed in accordance with standard practice. Therefore, a measure of the efficiency of the product for achieving the development of one or two follicles. Data was collected from 56 centres of the Autonomous Communities that accepted this observational study, until achieving a total of 410 ovulation induction cycles.
OBJECTIVES
Primary objective:
- To find the real proportion of cycles with mono-bifollicular development during the provision of care involving OI with follitropin alpha filled by mass
Secondary objectives:
- To evaluate if the use of follitropin alpha filled by mass has other clinical benefits such as a reduction in the number of cancelled cycles, of the dosage and time required and adverse effects
- Conditions
- Ovulation Induction
- Being tested
- Follitropin alpha (r-FSH)
- Keywords
- Ovulation induction, Ovarian Hyperstimulation Syndrome, Pregnancy, Fertility
- Medical subject headings
- Ovarian Hyperstimulation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follitropin alpha (r-FSH)Drug
Also called Gonal-f
The dosage and administration of follitropin alpha was according to each centre's protocol and within technical specification recommendations.
What is being measured
The primary outcome is the main question the study is designed to answer.
Follicular development
Number and size of follicles as determined through transvaginal ultrasound
Measured: First 10 months from the inclusion of the subjects
Secondary outcomes (2)
Secondary efficacy assessments
Duration of ovulation induction; total accumulated dosage of follitropin alpha; cycles cancelled due to insufficient response or due to risk of ovarian hyperstimulation; proportion of pregnancies
Measured: From baseline until the pregnancy or menstruation confirmation
Safety assessments
Incidence of adverse occurrences, in particular OHSS; proportion of multiple pregnancies and local reaction at the injection point.
Measured: First 10 months from the inclusion of the subjects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2010 (estimated)
- Study startMar 2004
- Primary completionJun 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovulation InductionStudies 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
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dr. Enrique Granados, Study director, Merck Serono Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01111084
- Sponsor's protocol ID
- IMP24846
- Acronym
- P450
- Status last verified
- Apr 2010
- First submitted
- 23 Apr 2010
- Last updated
- 16 Jul 2014
- Results posted
- 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
- Prospective Multi-centre Observational Study to Determine the Mono-bifollicular Development in Infertile Women Subjected to Ovulation Induction With Follitropin α
- ClinicalTrials.gov ID
- NCT01111084
- Acronym / sponsor ID
- P450 / IMP24846
- Conditions
- Ovulation Induction
- Keywords
- Ovulation induction, Ovarian Hyperstimulation Syndrome, Pregnancy, Fertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 27 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 prospective and multicentric observational study to determine the real mono-bifollicular development rate that is obtained under normal care conditions following ovulation induction (OI) treatment with follitropin-alpha filled by mass prescribed in accordance with standard practice.
Detailed description
In women with infertility due to anovulation, the main purpose of ovulation induction (OI) consists in inducing the mono or bifollicular and the subsequent ovulation in order to achieve pregnancy. The availability of recombinant gonadotropins obtained using genetically engineered techniques has meant a decisive and clear pharmacological advancement. Use of recombinant human follicle stimulating hormone (r-hFSH) offers a greater effectiveness (greater number of follicles/ ovocytes and a higher pregnancy rate) and efficiency (fewer number of blisters, fewer stimulation days; fewer number of cancellations and complications) in programmed coitus and artificial insemination like in-vitro fertilisation (IVF)/intra cytoplasmic sperm injection (ICSI) techniques. Further advances in obtaining better products for ovarian stimulation has led to production of a recombinant FSH (follitropin alpha) filled by mass preparation. This hormone becomes the most consistent and precise gonadotropin due to improvements in its quantification process.
Today, despite having accurate and modern tools for ovulation induction, in daily practice, doctors continue to "fight" against two old problems of assisted reproduction: multiple pregnancies and ovarian hyperstimulation syndrome (OHSS). Application of assisted reproduction techniques (ARTs) and the use of medication that induce ovulation, risk producing gestations and multiple births with a higher frequency than those observed in spontaneous gestations. One of the facts that result in the appearance of such problems is the high incidence of polycystic ovarian syndrome among the population of women who are infertile due to anovulation. These subjects are especially sensitive to ovarian stimulation, which leads to multiple follicular development, a higher risk of hyperstimulation and higher rates of multiple pregnancies.
Therefore, it seems clear that the search for developing mono or bifollicular cycles is important in ovarian induction cycles, for the purpose of preventing the above mentioned multiple pregnancy problems and the risk of OHSS. The intent of this study was to figure out the real mono-bifollicular development rate that is obtained under normal care conditions following OI treatment with follitropin alpha filled by mass prescribed in accordance with standard practice. Therefore, a measure of the efficiency of the product for achieving the development of one or two follicles. Data was collected from 56 centres of the Autonomous Communities that accepted this observational study, until achieving a total of 410 ovulation induction cycles.
OBJECTIVES
Primary objective:
- To find the real proportion of cycles with mono-bifollicular development during the provision of care involving OI with follitropin alpha filled by mass
Secondary objectives:
- To evaluate if the use of follitropin alpha filled by mass has other clinical benefits such as a reduction in the number of cancelled cycles, of the dosage and time required and adverse effects
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Female subjects who were infertile due to anovulation undergoing OI treatment with follitropin alpha prescribed in accordance with the standard practice and in accordance with the technical specifications.
Key inclusion criteria (1 listed)
- Premenopausal women with infertility caused by anovulation, who wished to conceive and were included in an ovulation induction (OI) treatment protocol for intrauterine insemination or for programmed coitus
Key exclusion criteria (8 listed)
- Subjects with hypersensitivity to follitropin alpha, to FSH or to any of the excipients
- Subjects with hypothalamic or pituitary tumours
- Subjects with increase in the size of the ovaries or cysts that were not due to polycystic ovary disease
- Subjects with gynaecologic haemorrhages of unknown aetiology
- Subjects with ovarian, uterine or mammary carcinoma
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 |
|---|---|---|
| Follitropin alpha (r-FSH)Also: Gonal-fThe dosage and administration of follitropin alpha was according to each centre's protocol and within technical specification recommendations. | Drug | – |
Primary outcome
Follicular development
Time frame: First 10 months from the inclusion of the subjects
Number and size of follicles as determined through transvaginal ultrasound
2 secondary outcomes
Secondary efficacy assessments
Time frame: From baseline until the pregnancy or menstruation confirmation
Safety assessments
Time frame: First 10 months from the inclusion of the subjects
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.
Related trials for Ovulation Induction
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Not yet recruiting
Oral GnRH Antagonist (Linzagolix) Versus Injectable GnRH Antagonist in Controlled Ovarian Stimulation for In Vitro Fertilization: A Randomized Controlled Non-Inferiority Trial With a Concurrent Comparator Cohort Undergoing Progestin-Primed Ovarian Stimulation (PPOS)
Infertility, Female, Ovulation Induction
RecruitingPhase 1
E.N.D.E.A.V.O.R.: An Exemestane Needed Dose Efficacy and Verification as an Ovulation Induction Regimen Study
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Progesterone Supplementation After Letrozole-stimulated Insemination
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RecruitingPhase 2/3
Autologous Platelet Rich Plasma Intraovarian Infusion for Poor Responders
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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.
Dr. Enrique Granados study director
Merck Serono Spain
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 Ovulation Induction, run by Merck KGaA, Darmstadt, Germany at 1 site in Spain.
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 1 inclusion and 8 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 Spain. 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?
Follicular development (time frame: First 10 months from the inclusion of the subjects). 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.