Ovulation InductionNCT01152866
An Open Label, Canadian Phase IIIb Study With Ovidrel in Ovulation Induction (OI) and Assisted Reproductive Technique (ART)
An observational study of Ovulation Induction and Infertility, run by EMD Serono.
Trial summary
With the development of the recombinant gonadotrophins, the use of human source proteins for the production of hormones has become unnecessary. These proteins, which are found in urinary preparations, have been thought to cause the local, post-injection adverse events (AEs) in some subjects. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ovulation Induction, Infertility
- What is being tested?
- Choriogonadotropin alpha (r-hCG)
- Type of treatment
- Injection or infusion
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- Dec 2003to Dec 2004
- 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 desiring pregnancy who had been unable to conceive and been diagnosed by a physician who is familiar with infertility and its monitoring.
Who may be able to join
- Infertile women desiring a pregnancy
- Subjects whose baseline hormonal values were within normal ranges as per local practice
- Subjects who were willing and able to comply with the protocol for the duration of the study
- Subjects who had given written informed consent, prior to treatment, with the understanding that consent might be withdrawn at any time without prejudice
Who cannot join
- Subjects with clinically significant disease
- Subjects who were known to be infected by human immunodeficiency virus (HIV), Hepatitis B or C
- Subjects who had any medical condition, which in the judgment of the investigator, may interfere with the absorption, distribution, metabolism or excretion of study drug
- Subjects with severe endometriosis
- Subjects with abnormal, undiagnosed gynaecological bleeding
- Subjects who had any contra-indication to being pregnant or carrying a pregnancy to term
Show all 12Show fewer
- Subjects who were pregnant or breast-feeding at the beginning of the cycle. Confirmation that the subject was not pregnant was to be established by a negative urine or serum pregnancy test in the 7 days prior to Study Day1
- Subjects with prior hypersensitivity to hCG preparations or one of their excipients
- Subjects with uncontrolled thyroid or adrenal dysfunction
- Subjects with uncontrolled organic intracranial lesion such as a pituitary tumour
- Subjects with ovarian cyst or enlargement of undetermined origin
- Subjects with sex hormone dependent tumors of the reproductive organs and breasts
About this study
Official title: An Observational Study Using Subcutaneous Ovidrel (Choriogonadotrophin Alfa) for Induction of Final Follicular Maturation and Early Luteinisation in Women Undergoing Ovarian Stimulation With Recombinant-human Follicle Stimulating Hormone (r-hFSH [Gonal-F®]).
With the development of the recombinant gonadotrophins, the use of human source proteins for the production of hormones has become unnecessary. These proteins, which are found in urinary preparations, have been thought to cause the local, post-injection adverse events (AEs) in some subjects.
There has been a demand by physicians for an alternative to urinary products for treatment. Due to allergies to urinary products, or other personal reasons, subjects were not able or willing to be treated with proteins of human origin. This study allowed subjects to be treated with the recombinant human chorionic gonadotropin (r hCG) (free of urinary proteins), which otherwise would not be possible. The study sponsor used this opportunity to collect additional safety data on the new recombinant product, (Ovidrel, r-hCG).
Read the detailed description
Approximately one in ten couples of reproductive age experiences infertility. Infertility may be caused by problems in men, in women or in both. A number of techniques can be used depending on the duration and type of infertility problems. The treatment of ovulation induction (OI) uses the help of exogenous gonadotrophins such as follicle stimulating hormone (FSH), luteinizing hormone (LH) and hCG in order to stimulate follicles and release oocytes for fertilization in the fallopian tubes.
Assisted reproductive technologies (ARTs), including in-vitro fertilization (IVF) and intra- cytoplasmic sperm injection (ICSI), increases the chances of success to obtain more than one embryo. In order to obtain more than one embryo, it is necessary to stimulate the growth and maturation of several follicles. Such a multiple follicular development is obtained by daily administration of a follicle stimulating hormone (r-hFSH, Gonal-F). When these follicles have reached a large enough size, the role of hCG is to achieve final oocyte maturation and initiation of follicular luteinization.
Serono International S.A. has developed a pharmaceutical preparation of human chorionic gonadotrophin (hCG) for clinical use through the application of recombinant DNA technology. The resulting product is choriogonadotrophin alpha, a pure recombinant human chorionic gonadotrophin (r-hCG). The corresponding drug product is marketed under the tradename Ovidrel. Ovidrel (choriogonadotrophin alpha for injection) has been approved in the United States, in the European Union and Australia.
OBJECTIVES The objective of this study was to collect safety information in order to confirm the already known profile of r- hCG (Ovidrel).
- Conditions
- Ovulation Induction, Infertility
- Being tested
- Choriogonadotropin alpha (r-hCG)
- Keywords
- Multifollicular stimulation, Pregnancy, Reproductive Techniques, Assisted, Fertilization in Vitro, Infertility
- 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.
Choriogonadotropin alpha (r-hCG)Drug
Also called Ovidrel
Choriogonadotropin alpha 250 μg was administered subcutaneously on the day following the last dose of follitropin alpha (Gonal-F).
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessment
Safety of Ovidrel was assessed through the recording, reporting and analysis of baseline medical conditions, adverse events, general physical examination, laboratory tests, and vital signs data.
Measured: Pre-treatment screening within 6 weeks prior to beginning GnRH-agonist therapy or stimulation day 1 (S1) to post-treatment period (30 days of the last administration of the investigational product)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study startDec 2003
- Primary completionDec 2004
- Study completionDec 2004
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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMD Serono
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Horia Ijacu, MD, Study director, EMD Serono a division of EMD Canada Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01152866
- Sponsor's protocol ID
- 24662
- Status last verified
- Aug 2013
- First submitted
- 28 Jun 2010
- Last updated
- 6 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study Using Subcutaneous Ovidrel (Choriogonadotrophin Alfa) for Induction of Final Follicular Maturation and Early Luteinisation in Women Undergoing Ovarian Stimulation With Recombinant-human Follicle Stimulating Hormone (r-hFSH [Gonal-F®]).
- ClinicalTrials.gov ID
- NCT01152866
- Acronym / sponsor ID
- 24662
- Conditions
- Ovulation Induction, Infertility
- Keywords
- Multifollicular stimulation, Pregnancy, Reproductive Techniques, Assisted, Fertilization in Vitro, Infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- EMD SeronoIndustry (pharma, biotech, devices)
- Study start
- Dec 2003
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 29 Jun 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.
With the development of the recombinant gonadotrophins, the use of human source proteins for the production of hormones has become unnecessary. These proteins, which are found in urinary preparations, have been thought to cause the local, post-injection adverse events (AEs) in some subjects.
There has been a demand by physicians for an alternative to urinary products for treatment. Due to allergies to urinary products, or other personal reasons, subjects were not able or willing to be treated with proteins of human origin. This study allowed subjects to be treated with the recombinant human chorionic gonadotropin (r hCG) (free of urinary proteins), which otherwise would not be possible. The study sponsor used this opportunity to collect additional safety data on the new recombinant product, (Ovidrel, r-hCG).
Detailed description
Approximately one in ten couples of reproductive age experiences infertility. Infertility may be caused by problems in men, in women or in both. A number of techniques can be used depending on the duration and type of infertility problems. The treatment of ovulation induction (OI) uses the help of exogenous gonadotrophins such as follicle stimulating hormone (FSH), luteinizing hormone (LH) and hCG in order to stimulate follicles and release oocytes for fertilization in the fallopian tubes.
Assisted reproductive technologies (ARTs), including in-vitro fertilization (IVF) and intra- cytoplasmic sperm injection (ICSI), increases the chances of success to obtain more than one embryo. In order to obtain more than one embryo, it is necessary to stimulate the growth and maturation of several follicles. Such a multiple follicular development is obtained by daily administration of a follicle stimulating hormone (r-hFSH, Gonal-F). When these follicles have reached a large enough size, the role of hCG is to achieve final oocyte maturation and initiation of follicular luteinization.
Serono International S.A. has developed a pharmaceutical preparation of human chorionic gonadotrophin (hCG) for clinical use through the application of recombinant DNA technology. The resulting product is choriogonadotrophin alpha, a pure recombinant human chorionic gonadotrophin (r-hCG). The corresponding drug product is marketed under the tradename Ovidrel. Ovidrel (choriogonadotrophin alpha for injection) has been approved in the United States, in the European Union and Australia.
OBJECTIVES The objective of this study was to collect safety information in order to confirm the already known profile of r- hCG (Ovidrel).
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 desiring pregnancy who had been unable to conceive and been diagnosed by a physician who is familiar with infertility and its monitoring.
Key inclusion criteria (4 listed)
- Infertile women desiring a pregnancy
- Subjects whose baseline hormonal values were within normal ranges as per local practice
- Subjects who were willing and able to comply with the protocol for the duration of the study
- Subjects who had given written informed consent, prior to treatment, with the understanding that consent might be withdrawn at any time without prejudice
Key exclusion criteria (12 listed)
- Subjects with clinically significant disease
- Subjects who were known to be infected by human immunodeficiency virus (HIV), Hepatitis B or C
- Subjects who had any medical condition, which in the judgment of the investigator, may interfere with the absorption, distribution, metabolism or excretion of study drug
- Subjects with severe endometriosis
- Subjects with abnormal, undiagnosed gynaecological bleeding
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 |
|---|---|---|
| Choriogonadotropin alpha (r-hCG)Also: OvidrelChoriogonadotropin alpha 250 μg was administered subcutaneously on the day following the last dose of follitropin alpha (Gonal-F). | Drug | – |
Primary outcome
Safety assessment
Time frame: Pre-treatment screening within 6 weeks prior to beginning GnRH-agonist therapy or stimulation day 1 (S1) to post-treatment period (30 days of the last administration of the investigational product)
Safety of Ovidrel was assessed through the recording, reporting and analysis of baseline medical conditions, adverse events, general physical examination, laboratory tests, and vital signs data.
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 6 Aug 2013.
Related trials for Ovulation Induction
Recruiting
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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
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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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RecruitingPhase 4
Progesterone Supplementation After Letrozole-stimulated Insemination
Infertility
RecruitingPhase 2/3
Autologous Platelet Rich Plasma Intraovarian Infusion for Poor Responders
Poor Response to Ovulation Induction, Infertility, Female
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.
Horia Ijacu, MD study director
EMD Serono a division of EMD Canada Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovulation Induction and Infertility, run by EMD Serono.
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 12 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 6 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Safety assessment (time frame: Pre-treatment screening within 6 weeks prior to beginning GnRH-agonist therapy or stimulation day 1 (S1) to post-treatment period (30 days of the last administration of the investigational product)). 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 6 Aug 2013.