Female InfertilityPhase 1NCT01604044
Highly Purified Menotropin (HP-hMG) Versus Recombinant FSH (rFSH) Plus Recombinant LH (rLH) in Intrauterine Insemination Cycles in Women ≥35 Years: a Prospective Randomized Trial.
A Phase 1 study testing Meropur 150 a day and Gonal-f 150 plus Luveris 150 in people with Female Infertility, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
This study evaluates the effects of different therapies in ovulation induction in Intrauterine Insemination Cycles. Read more about this study
- Who is it for?
- Ages 35 to 41 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female Infertility
- What is being tested?
- Meropur 150 a day and Gonal-f 150 plus Luveris 150
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 579 participants
- Where
- 1 siteItaly
- Study dates
- May 2012to Sep 2013
- Phase
- Phase 1
- 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 35 to 41 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women with story of infertility sine causa and mild-moderate male factor
- regular ovulatory menstrual cycles
- BMI ≤27 kg/m2
- normal day 3 hormonal pattern
- bilateral tubal patency
Who cannot join
- mono/bilateral tubal occlusion,
- severe male factor
- polycystic ovarian syndrome or any systemic disease or endocrine or metabolic abnormalities
- pelvic inflammatory disease
- endometriosis
- sexual organ malformations
- neoplasms or breast pathology incompatible with gonadotropin stimulation.
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the effects of different therapies in ovulation induction in Intrauterine Insemination Cycles.
- Conditions
- Female Infertility
- Being tested
- Meropur 150 a day, Gonal-f 150 plus Luveris 150
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meropur 150 a dayDrug
one subcutaneous injection a day
Gonal-f 150 plus Luveris 150Drug
one subcutaneous injection a day
| Study group | Role | What they receive |
|---|---|---|
| HP-hMG | Active comparator | Not described Receives: Drug: Meropur 150 a day |
| rFSH plus rLH | Active comparator | Not described Receives: Drug: Gonal-f 150 plus Luveris 150 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ongoing pregnancy rate
Measured: 12 weeks
Secondary outcomes (1)
number of cancelled cycles for low or no response, the number of interrupted cycles for high risk of OHSS and multiple pregnancies
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2012 (estimated)
- Study startMay 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Female 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 579 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosanna Apa, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01604044
- Sponsor's protocol ID
- Meropur2009
- Status last verified
- Sep 2014
- First submitted
- 21 May 2012
- Last updated
- 5 Sep 2014
- Results posted
- No
Publications
Moro F, Scarinci E, Palla C, Romani F, Familiari A, Tropea A, Leoncini E, Lanzone A, Apa R. Highly purified hMG versus recombinant FSH plus recombinant LH in intrauterine insemination cycles in women >/=35 years: a RCT. Hum Reprod. 2015 Jan;30(1):179-85. doi: 10.1093/humrep/deu302. Epub 2014 Nov 14.
PubMed 25398971
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Highly Purified Menotropin (HP-hMG) Versus Recombinant FSH (rFSH) Plus Recombinant LH (rLH) in Intrauterine Insemination Cycles in Women ≥35 Years: a Prospective Randomized Trial.
- ClinicalTrials.gov ID
- NCT01604044
- Acronym / sponsor ID
- Meropur2009
- Conditions
- Female Infertility
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 579 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 23 May 2012 (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 study evaluates the effects of different therapies in ovulation induction in Intrauterine Insemination Cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HP-hMG | Active comparator | Drug: Meropur 150 a day |
| rFSH plus rLH | Active comparator | Drug: Gonal-f 150 plus Luveris 150 |
Who may qualify
- Ages
- 35 to 41 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- women with story of infertility sine causa and mild-moderate male factor
- regular ovulatory menstrual cycles
- BMI ≤27 kg/m2
- normal day 3 hormonal pattern
- bilateral tubal patency
Key exclusion criteria (7 listed)
- mono/bilateral tubal occlusion,
- severe male factor
- polycystic ovarian syndrome or any systemic disease or endocrine or metabolic abnormalities
- pelvic inflammatory disease
- endometriosis
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 |
|---|---|---|
| Meropur 150 a dayone subcutaneous injection a day | Drug | HP-hMG |
| Gonal-f 150 plus Luveris 150one subcutaneous injection a day | Drug | rFSH plus rLH |
Primary outcome
ongoing pregnancy rate
Time frame: 12 weeks
1 secondary outcome
number of cancelled cycles for low or no response, the number of interrupted cycles for high risk of OHSS and multiple pregnancies
Time frame: 30 days
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 5 Sep 2014.
- Derived from this study: PubMed 25398971Moro F, Scarinci E, Palla C, Romani F, Familiari A, Tropea A, Leoncini E, Lanzone A, Apa R. Highly purified hMG versus recombinant FSH plus recombinant LH in intrauterine insemination cycles in women >/=35 years: a RCT. Hum Reprod. 2015 Jan;30(1):179-85. doi: 10.1093/humrep/deu302. Epub 2014 Nov 14.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Meropur 150 a day and Gonal-f 150 plus Luveris 150 in people with Female Infertility, run by Catholic University of the Sacred Heart at 1 site in Italy.
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 5 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 5 Sep 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 Italy. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
ongoing pregnancy rate (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01604044, which also lists 1 linked publication.
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 5 Sep 2014.