InfertilityNCT02322398
Ovarian Stimulation With Recombinant Gonadotropins vs. Human Menopausal Gonadotropin in In Vitro Fertilization
An observational study of Infertility, run by University of Turin, Italy at 1 site in Italy.
Trial summary
The purpose of this retrospective study was to assess the outcome of In Vitro Fertilization (IVF) according to the type of medication used for controlled ovarian stimulation (COS). Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- rFSH plus rLH and hMG
- How many people
- 848 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2010to Aug 2014
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Infertile women requiring IVF and classified as expected poor responders and/or expected normal responders on the basis of age, basal FSH circulating levels, anti-mullerian Hormone (AMH) circulating level and basal antral follicle count.
Who may be able to join
- infertility
- need to undergo IVF
- circulating basal FSH above 6.5 UI/l
- circulating AMH 0.1-2 ng/ml
- basal antral follicle count between 3 and 15
Who cannot join
- circulating basal FSH below 6.5 UI/l
- circulating AMH below 0.1 ng/ml or above 2 ng/ml
- basal antral follicle count below 3 or above 15
Trial locations and contacts
1 site in 1 country.
Italy1 site
Physiopathology of Reproduction and IVF Unit, S. Anna Hospital
Torino, 10126
About this study
Official title: Controlled Ovarian Stimulation With Recombinant Follicle Stimulating Hormone Plus Recombinant Luteinizing Hormone vs. Human Menopausal Gonadotropin in In Vitro Fertilization: Retrospective Analysis of Real Life Data
The purpose of this retrospective study was to assess the outcome of In Vitro Fertilization (IVF) according to the type of medication used for controlled ovarian stimulation (COS). The study compared the pregnancy rate obtained by 398 patients who had received COS with recombinant Follicle Stimulating Hormone (rFSH) plus recombinant Luteinising Hormone (rLH) in 2:1 ratio vs. the one observed in 450 patients who had been treated with human Menopausal Gonadotropin (hMG), stratifying results according to the number of retrieved oocytes.
Read the detailed description
Data were retrospectively collected from the clinical charts of our In Vitro Fertilization (IVF) Unit database. Among 3,416 cases recorded in the database, patients classified as expected poor responders and/or expected normal responders, requiring an average daily gonadotropin dose of 150-300 IU, were selected. A total of 848 patients matched this criterion and were included in the final analysis; of these, 398 (Group A) had been stimulated with rFSH+rLH, whereas 450 (Group B) had been treated with hMG.
Patients in Group A (n=398) had been stimulated either with a starting dose of 150-300 International Units per day (IU/d) recombinant Follicle Stimulating Hormone (rFSH) plus 75-150 IU/d recombinant Luteinising Hormone (rLH) in 2:1 ratio. On day 6-7 of ovarian stimulation, the gonadotropin dose had been adapted according to the ovarian response, always maintaining the same rFSH:rLH ratio.
Patients in Group B (n=450) had received 150-300 IU/d human Menopausal Gonadotropin, eventually adjusting the dose on day 6-7 of ovarian stimulation.
Either medication had been administered within a "long" protocol with Gonadotropin-releasing Hormone (GnRH)-agonist or a "short" protocol with GnRH-antagonist. The COS regimen (type of protocol and type of medication) had been prescribed in the absence of any pre-fixed criteria at the time of prescription by different physicians of the Unit, basing the choice of appropriate dosages on the clinical experience, considering parameters such as age, small antrall follicle count and basal day 3 FSH.
The classical "long" protocol had been performed administering the GnRH-agonist buserelin (900 mcg/d intranasally) from day 21 of the preceding cycle. In the "short" protocol, the GnRH-antagonist cetrorelix had been started at a subcutaneous dose of 0.25 mg/d according to a flexible schedule, when at least one follicle ≥14 mm diameter was observed at ultrasound (US).
COS had been monitored by transvaginal US plus serum estradiol (E2) measurement performed every second day from stimulation day 6-7. From stimulation day 6-7 onward, checkpoints had been performed until at least one dominant follicle had reached 18 mm diameter, with appropriate E2 levels. At this point, ovulation had been triggered by injecting subcutaneously 10,000 IU of human Chorionic Gonadotropin, and transvaginal US-guided oocyte aspiration (OPU) had been performed approximately 36-37 hours after hCG injection under local anesthesia (paracervical block).
Classical IVF or ICSI had followed, according to the clinical indication. After two days of in vitro culture, embryos had been scored and 1-3 of them had been transferred in uteri using a soft catheter under US guidance.
The luteal phase had been supported administering 180 mg/d natural progesterone for 15 days. Pregnancy had been assessed by serum hCG assay after 15 days from embryo transfer and then confirmed if at least one gestational sac was visualized at transvaginal US after two further weeks.
- Conditions
- Infertility
- Being tested
- rFSH plus rLH, hMG
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rFSH plus rLHDrug
Also called Gonal F, Luveris, Pergoveris
150-300 IU/d rFSH plus 75-150 IU/d rLH in 2:1 ratio
hMGDrug
Also called Meropur
150-300 IU/d hMG
| Study group | Role | What they receive |
|---|---|---|
| Group A | Patients who had been stimulated with a starting dose of 150-300 IU/d rFSH plus 75-150 IU/d rLH in 2:1 ratio. Receives: Drug: rFSH plus rLH | |
| Group B | Patients who had been stimulated with a starting dose of 150-300 IU/d hMG. Receives: Drug: hMG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate per embryo transfer (PR/ET)
Measured: First transvaginal US examination three weeks after a positive pregnancy test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startMar 2010
- Primary completionAug 2014
- Study completionAug 2014
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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 848 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Revelli, University of Turin, Italy
- Investigators
- Alberto Revelli, MD PhD, Principal investigator, Physiopathology of Reproduction and IVF Unit, S. Anna Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02322398
- Sponsor's protocol ID
- FDR-1-2014
- Status last verified
- Dec 2014
- First submitted
- 17 Dec 2014
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Ovarian Stimulation With Recombinant Follicle Stimulating Hormone Plus Recombinant Luteinizing Hormone vs. Human Menopausal Gonadotropin in In Vitro Fertilization: Retrospective Analysis of Real Life Data
- ClinicalTrials.gov ID
- NCT02322398
- Acronym / sponsor ID
- FDR-1-2014
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 848 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 23 Dec 2014 (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.
The purpose of this retrospective study was to assess the outcome of In Vitro Fertilization (IVF) according to the type of medication used for controlled ovarian stimulation (COS). The study compared the pregnancy rate obtained by 398 patients who had received COS with recombinant Follicle Stimulating Hormone (rFSH) plus recombinant Luteinising Hormone (rLH) in 2:1 ratio vs. the one observed in 450 patients who had been treated with human Menopausal Gonadotropin (hMG), stratifying results according to the number of retrieved oocytes.
Detailed description
Data were retrospectively collected from the clinical charts of our In Vitro Fertilization (IVF) Unit database. Among 3,416 cases recorded in the database, patients classified as expected poor responders and/or expected normal responders, requiring an average daily gonadotropin dose of 150-300 IU, were selected. A total of 848 patients matched this criterion and were included in the final analysis; of these, 398 (Group A) had been stimulated with rFSH+rLH, whereas 450 (Group B) had been treated with hMG.
Patients in Group A (n=398) had been stimulated either with a starting dose of 150-300 International Units per day (IU/d) recombinant Follicle Stimulating Hormone (rFSH) plus 75-150 IU/d recombinant Luteinising Hormone (rLH) in 2:1 ratio. On day 6-7 of ovarian stimulation, the gonadotropin dose had been adapted according to the ovarian response, always maintaining the same rFSH:rLH ratio.
Patients in Group B (n=450) had received 150-300 IU/d human Menopausal Gonadotropin, eventually adjusting the dose on day 6-7 of ovarian stimulation.
Either medication had been administered within a "long" protocol with Gonadotropin-releasing Hormone (GnRH)-agonist or a "short" protocol with GnRH-antagonist. The COS regimen (type of protocol and type of medication) had been prescribed in the absence of any pre-fixed criteria at the time of prescription by different physicians of the Unit, basing the choice of appropriate dosages on the clinical experience, considering parameters such as age, small antrall follicle count and basal day 3 FSH.
The classical "long" protocol had been performed administering the GnRH-agonist buserelin (900 mcg/d intranasally) from day 21 of the preceding cycle. In the "short" protocol, the GnRH-antagonist cetrorelix had been started at a subcutaneous dose of 0.25 mg/d according to a flexible schedule, when at least one follicle ≥14 mm diameter was observed at ultrasound (US).
COS had been monitored by transvaginal US plus serum estradiol (E2) measurement performed every second day from stimulation day 6-7. From stimulation day 6-7 onward, checkpoints had been performed until at least one dominant follicle had reached 18 mm diameter, with appropriate E2 levels. At this point, ovulation had been triggered by injecting subcutaneously 10,000 IU of human Chorionic Gonadotropin, and transvaginal US-guided oocyte aspiration (OPU) had been performed approximately 36-37 hours after hCG injection under local anesthesia (paracervical block).
Classical IVF or ICSI had followed, according to the clinical indication. After two days of in vitro culture, embryos had been scored and 1-3 of them had been transferred in uteri using a soft catheter under US guidance.
The luteal phase had been supported administering 180 mg/d natural progesterone for 15 days. Pregnancy had been assessed by serum hCG assay after 15 days from embryo transfer and then confirmed if at least one gestational sac was visualized at transvaginal US after two further weeks.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Drug: rFSH plus rLHPatients who had been stimulated with a starting dose of 150-300 IU/d rFSH plus 75-150 IU/d rLH in 2:1 ratio. |
| Group B | – | Drug: hMGPatients who had been stimulated with a starting dose of 150-300 IU/d hMG. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Infertile women requiring IVF and classified as expected poor responders and/or expected normal responders on the basis of age, basal FSH circulating levels, anti-mullerian Hormone (AMH) circulating level and basal antral follicle count.
Key inclusion criteria (5 listed)
- infertility
- need to undergo IVF
- circulating basal FSH above 6.5 UI/l
- circulating AMH 0.1-2 ng/ml
- basal antral follicle count between 3 and 15
Key exclusion criteria (3 listed)
- circulating basal FSH below 6.5 UI/l
- circulating AMH below 0.1 ng/ml or above 2 ng/ml
- basal antral follicle count below 3 or above 15
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 |
|---|---|---|
| rFSH plus rLHAlso: Gonal F, Luveris, Pergoveris150-300 IU/d rFSH plus 75-150 IU/d rLH in 2:1 ratio | Drug | Group A |
| hMGAlso: Meropur150-300 IU/d hMG | Drug | Group B |
Primary outcome
Pregnancy rate per embryo transfer (PR/ET)
Time frame: First transvaginal US examination three weeks after a positive pregnancy test
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 23 Dec 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.
Alberto Revelli, MD PhD principal investigator
Physiopathology of Reproduction and IVF Unit, S. Anna Hospital
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 University of Turin, Italy 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 3 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 23 Dec 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.
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?
Pregnancy rate per embryo transfer (PR/ET) (time frame: First transvaginal US examination three weeks after a positive pregnancy test). 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 23 Dec 2014.