InfertilityPhase 3NCT01081756
A Study Using Recombinant Human Chorionic Gonadotrophin (rhCG, Ovidrel®) in the Induction of Final Follicle Maturation and Early Luteinization in Chinese Women Undergoing in Vitro Fertilization and Embryo Transfer (IVF/ET)
A Phase 3 study testing r-hCG and Urinary-hCG in people with Infertility, run by Merck KGaA, Darmstadt, Germany at 1 site in China.
Trial summary
This was an open, randomized, comparative study using rhCG (Ovidrel) in the induction of final follicle maturation and early luteinization in Chinese female subjects undergoing IVF or ET. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Infertility
- What is being tested?
- r-hCG and Urinary-hCG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 1 siteChina
- Study dates
- Dec 2003to Sep 2004
- Phase
- Phase 3
- 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
Who may be able to join
- Infertility regular ovulatory menstrual cycles;
- Early luteal phase serum levels:
- FSH≤ 10IU/l
- LH≤ 10IU/l
- PRL≤ 30ng/ml
- T≤ 50pg/ml
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- Haematology, blood chemistry, urinalysis normal
- Both ovaries present
- < 3 previous ART cycles, no ART cycles for 2 menstrual cycles
Who cannot join
- With a poor response to gonadotrophin stimulation, such as ≤3 oocytes collected in any previous IVF cycle
- Any medical condition may interfere with the absorption, distribution, metabolism or excretion of the drug.
- Had previous severe ovarian hyperstimulation syndrome(OHSS)
- A body mass index (BMI) >25 kg/m2
- Any contraindication to being pregnant and/or carrying a pregnancy to term
- Extra-uterine pregnancy within the last 3 months
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- A clinically significant systemic disease
- Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus
- Abnormal gynaecological bleeding of undetermined origin
- Known allergy or hypersensitivity to human gonadotrophin preparations
- Simultaneous participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open, Randomized, Comparative Study Using Recombinant Human Chorionic Gonadotrophin (rhCG, Ovidrel®) in the Induction of Final Follicle Maturation and Early Luteinization in Chinese Women Undergoing in Vitro Fertilization and Embryo Transfer (IVF/ET)
This was an open, randomized, comparative study using rhCG (Ovidrel) in the induction of final follicle maturation and early luteinization in Chinese female subjects undergoing IVF or ET.
Read the detailed description
This was an open, randomized, comparative multicentric, phase III study to evaluate the safety and efficacy of rhCG in comparison with urinary hCG in the induction of final follicle maturation and early luteinization in 200 Chinese female subjects undergoing superovulation. The study was organized on an outpatient basis in subjects undergoing assisted reproductive technologies (ART). All subjects underwent pituitary down- regulation per each center's normal practice prior to and during stimulation of multiple follicular development. The subjects were randomized into 2 groups. One group received rhCG 250mcg and the other group received urinary hCG (Profasi®) 10,000IU. Each subject in both groups received a single injection of hCG when the follicular development was judged to be adequate. Oocytes were retrieved 36-38 hours after the hCG injection and fertilized in vitro. Not more than 3 embryos or 2 blastocysts were to be replaced. Progesterone was administered daily according to center's normal practice, starting after the oocyte pick up and continuing until a negative pregnancy test or for the first 3 weeks of pregnancy if the subject was pregnant. The subject was followed up and the treatment outcome (negative pregnancy test or pregnancy) was recorded.
A phase I sub-study to evaluate the pharmacokinetics of single subcutaneous (s.c.) administrations of rhCG was conducted on 24 healthy Chinese female subjects in China. The subjects were randomized into 3 groups. Each group received a single dose of 250mcg or 500mcg or 750 mcg of rhCG. Blood samples were collected at predetermined intervals after the injection. Human chorionic gonadotropin serum levels were measured with the Serono MAIAclone and the in vitro bioassay MA-10. Safety was assessed by the incidence and severity of adverse events (AEs), including multiple pregnancy and ovarian hyperstimulation syndrome (OHSS) and significant changes in laboratory values.
- Conditions
- Infertility
- Being tested
- r-hCG, Urinary-hCG
- Keywords
- Reproductive technology; Assisted, recombinant human chorionic hormone (r-hCG)
- 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.
r-hCGDrug
Also called Ovitrelle or Ovidrel
r-hCG (250 mcg) injection subcutaneously (s.c.) or intramuscularly (i.m.)
Urinary-hCGDrug
Also called Profasi
Urinary hCG (10,000 IU) injection s.c. or i.m.
| Study group | Role | What they receive |
|---|---|---|
| Subjects treated with r-hCG | Experimental | Subjects treated with r-hCG Receives: Drug: r-hCG |
| Subjects treated with urinary hCG | Active comparator | Subjects treated with urinary hCG Receives: Drug: Urinary-hCG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of oocyte retrieved
Measured: 36 hrs after hCG administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2010 (estimated)
- Study startDec 2003
- Study completionSep 2004
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Huafei Li, Study director, Serono Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01081756
- Sponsor's protocol ID
- IMP-25346
- Status last verified
- Mar 2010
- First submitted
- 4 Mar 2010
- Last updated
- 31 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Randomized, Comparative Study Using Recombinant Human Chorionic Gonadotrophin (rhCG, Ovidrel®) in the Induction of Final Follicle Maturation and Early Luteinization in Chinese Women Undergoing in Vitro Fertilization and Embryo Transfer (IVF/ET)
- ClinicalTrials.gov ID
- NCT01081756
- Acronym / sponsor ID
- IMP-25346
- Conditions
- Infertility
- Keywords
- Reproductive technology; Assisted, recombinant human chorionic hormone (r-hCG)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- Dec 2003
- Study completion
- Sep 2004 (actual)
- First posted
- 5 Mar 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 was an open, randomized, comparative study using rhCG (Ovidrel) in the induction of final follicle maturation and early luteinization in Chinese female subjects undergoing IVF or ET.
Detailed description
This was an open, randomized, comparative multicentric, phase III study to evaluate the safety and efficacy of rhCG in comparison with urinary hCG in the induction of final follicle maturation and early luteinization in 200 Chinese female subjects undergoing superovulation. The study was organized on an outpatient basis in subjects undergoing assisted reproductive technologies (ART). All subjects underwent pituitary down- regulation per each center's normal practice prior to and during stimulation of multiple follicular development. The subjects were randomized into 2 groups. One group received rhCG 250mcg and the other group received urinary hCG (Profasi®) 10,000IU. Each subject in both groups received a single injection of hCG when the follicular development was judged to be adequate. Oocytes were retrieved 36-38 hours after the hCG injection and fertilized in vitro. Not more than 3 embryos or 2 blastocysts were to be replaced. Progesterone was administered daily according to center's normal practice, starting after the oocyte pick up and continuing until a negative pregnancy test or for the first 3 weeks of pregnancy if the subject was pregnant. The subject was followed up and the treatment outcome (negative pregnancy test or pregnancy) was recorded.
A phase I sub-study to evaluate the pharmacokinetics of single subcutaneous (s.c.) administrations of rhCG was conducted on 24 healthy Chinese female subjects in China. The subjects were randomized into 3 groups. Each group received a single dose of 250mcg or 500mcg or 750 mcg of rhCG. Blood samples were collected at predetermined intervals after the injection. Human chorionic gonadotropin serum levels were measured with the Serono MAIAclone and the in vitro bioassay MA-10. Safety was assessed by the incidence and severity of adverse events (AEs), including multiple pregnancy and ovarian hyperstimulation syndrome (OHSS) and significant changes in laboratory values.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects treated with r-hCG | Experimental | Drug: r-hCGSubjects treated with r-hCG |
| Subjects treated with urinary hCG | Active comparator | Drug: Urinary-hCGSubjects treated with urinary hCG |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Infertility regular ovulatory menstrual cycles;
- Early luteal phase serum levels:
- FSH≤ 10IU/l
- LH≤ 10IU/l
- PRL≤ 30ng/ml
Key exclusion criteria (11 listed)
- With a poor response to gonadotrophin stimulation, such as ≤3 oocytes collected in any previous IVF cycle
- Any medical condition may interfere with the absorption, distribution, metabolism or excretion of the drug.
- Had previous severe ovarian hyperstimulation syndrome(OHSS)
- A body mass index (BMI) >25 kg/m2
- Any contraindication to being pregnant and/or carrying a pregnancy to term
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 |
|---|---|---|
| r-hCGAlso: Ovitrelle or Ovidrelr-hCG (250 mcg) injection subcutaneously (s.c.) or intramuscularly (i.m.) | Drug | Subjects treated with r-hCG |
| Urinary-hCGAlso: ProfasiUrinary hCG (10,000 IU) injection s.c. or i.m. | Drug | Subjects treated with urinary hCG |
Primary outcome
Number of oocyte retrieved
Time frame: 36 hrs after hCG administration
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 31 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.
Huafei Li study director
Serono Singapore
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 r-hCG and Urinary-hCG in people with Infertility, run by Merck KGaA, Darmstadt, Germany at 1 site in China.
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 9 inclusion and 11 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 31 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 China. 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?
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?
Number of oocyte retrieved (time frame: 36 hrs 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 31 Jul 2014.