InfertilityNCT02244866
Efficacy of Pergoveris in Aged IVF Patients
A study testing Pergoveris (FSH and LH) and Follitropin alpha (FSH) in people with Infertility, run by Vietnam National University at 1 site in Vietnam.
Trial summary
To compare the efficacy between LH supplementation (Pergoveris) and non-LH supplementation (Follitropin alpha) in patients aged ≥ 35 years undergoing IVF treatment. Study hypothesis: Pergoveris (LH supplementation) is better than follitropin alpha (non-LH supplementation) for ovarian stimulation in aged IVF patients. Read more about this study
- Who is it for?
- Ages 35 to 45 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Pergoveris (FSH and LH) and Follitropin alpha (FSH)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteVietnam
- Study dates
- Oct 2012to Jun 2014
- Phase
- Interventional
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- age ≥ 35 years
- body mass index <28 kg/m2
- had ≤ 3 previous IVF attempts
- receiving a GnRH-antagonist protocol
- agreement to participate in the study, and to disclose any medical events to the investigator. The subject must be willing and able to comply with the protocol requirements for the duration of the study.
- have given written informed consent with the understanding that the subject may withdraw consent at any time
Who cannot join
- participating in another interventional clinical trial
- PCOS or WHO group 1
- have uterine abnormalities
- have endocrine disorders such as hyperprolactinemia, thyroid disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial to Compare the Efficacy Between Pergoveris and Follitropin Alfa in Ovarian Stimulation in Patients Aged ≥ 35 Years
To compare the efficacy between LH supplementation (Pergoveris) and non-LH supplementation (Follitropin alpha) in patients aged ≥ 35 years undergoing IVF treatment.
Study hypothesis: Pergoveris (LH supplementation) is better than follitropin alpha (non-LH supplementation) for ovarian stimulation in aged IVF patients.
Read the detailed description
A randomized controlled single center study.
Based on the difference of 19.1% in the clinical pregnancy rate between the two treatment groups, with and without LH supplementation, in a previous study, with 90% power and a 2-sided P-value of 0.05, the number of subjects required was 109 per group (total 218). The recruitment target was 120 subjects per group (total 240) to allow for dropouts.
Eligible subjects were randomized in blocks of 4 via a computer generated random number list to either the Pergoveris arm or the follitropin alpha arm.
Ovarian stimulation was performed by using GnRH antagonist protocol.
Follitropin alfa (recombinant FSH) was administered on day 2 or day 3 of the menstrual cycle. The first FSH dose was determined according to each individual patient, based on the process as follows:
- AFC ≤ 6: 300 IU/day
- AFC 7-15: 225 IU/day
- AFC ≥ 16: 150 IU/day
GnRH antagonist (Cetrotide, Merck-Serono) was administered on day 5 of FSH administration.
- Recombinant LH (in the form of Pergoveris) was supplemented from day 6 of FSH administration. Patients in the Pergoveris group would be administered a reduced dose of recombinant FSH (reduced by 150 IU/day) which was replaced with Pergoveris (150IU FSH + 75IU LH)/day.
- The Follitropin alpha group retained recombinant FSH. In both groups, if the number of developing follicles was inappropriate, the dose could be titrated depending on the physician's judgment.
Monitoring the follicular development was performed by vaginal ultrasound probe, quantifying LH, estradiol and progesterone, starting from day 5 of FSH, based on the current processes of the hospital.
OPU and embryo transfer: OPU was performed 36 hours after hCG administration. Embryos were transferred on day 2.
Luteal phase support: daily vaginal progesterone
Pregnancy testing and ultrasound: a pregnancy test was done 14 days after embryo transfer. Beta hCG > 5mIU/ml was considered positive. Fetal ultrasound was performed 3 weeks after a positive pregnancy test to verify clinical pregnancy.
- Conditions
- Infertility
- Being tested
- Pergoveris (FSH and LH), Follitropin alpha (FSH)
- Keywords
- IVF, LH supplementation, ovarian stimulation, poor responder
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pergoveris (FSH and LH)Drug
Also called Pergoveris
Drugs are injected subcutaneously everyday until ovarian follicles reach 17mm in diameter.
Follitropin alpha (FSH)Drug
Also called Gonal-F
Drugs are injected subcutaneously everyday until ovarian follicles reach 17mm in diameter.
| Study group | Role | What they receive |
|---|---|---|
| Pergoveris (FSH and LH) | Active comparator | 150 IU of recombinant FSH and 75 IU of recombinant LH (Pergoveris) daily subcutaneous injection Receives: Drug: Pergoveris (FSH and LH) |
| Follitropin alpha (FSH) | Active comparator | 150 IU of recombinant FSH (follitropin alpha or Gonal-F) daily subcutaneous injection Receives: Drug: Follitropin alpha (FSH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy
Clinical pregnancy is defined by the image gestational sac under ultrasonography.
Measured: 7 weeks after embryo transfer
Live birth
Live birth is defined if a live newborn delivered.
Measured: at the time of delivery
Secondary outcomes (1)
Total FSH international units (IU) used for stimulation
Calculate total number of IU of FSH used for stimulation at the last day of stimulation regime.
Measured: Measure at the time when stimulation finishes, eg. in average 10-11 days, maximum 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startOct 2012
- Primary completionApr 2014
- Study completionJun 2014
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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vietnam National University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manh Tuong Ho, Vietnam National University
- Investigators
- Tuong M Ho, MD, Principal investigator, CGRH, School of Medicine, Vietnam National University HCMC, Vietnam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02244866
- Sponsor's protocol ID
- NCKH/CGRH_01_2012
- Status last verified
- Dec 2014
- First submitted
- 16 Sep 2014
- Last updated
- 25 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Vuong TN, Phung HT, Ho MT. Recombinant follicle-stimulating hormone and recombinant luteinizing hormone versus recombinant follicle-stimulating hormone alone during GnRH antagonist ovarian stimulation in patients aged >/=35 years: a randomized controlled trial. Hum Reprod. 2015 May;30(5):1188-95. doi: 10.1093/humrep/dev038. Epub 2015 Mar 3.
PubMed 25740882
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Compare the Efficacy Between Pergoveris and Follitropin Alfa in Ovarian Stimulation in Patients Aged ≥ 35 Years
- ClinicalTrials.gov ID
- NCT02244866
- Acronym / sponsor ID
- NCKH/CGRH_01_2012
- Conditions
- Infertility
- Keywords
- IVF, LH supplementation, ovarian stimulation, poor responder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Vietnam National UniversityUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 19 Sep 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.
To compare the efficacy between LH supplementation (Pergoveris) and non-LH supplementation (Follitropin alpha) in patients aged ≥ 35 years undergoing IVF treatment.
Study hypothesis: Pergoveris (LH supplementation) is better than follitropin alpha (non-LH supplementation) for ovarian stimulation in aged IVF patients.
Detailed description
A randomized controlled single center study.
Based on the difference of 19.1% in the clinical pregnancy rate between the two treatment groups, with and without LH supplementation, in a previous study, with 90% power and a 2-sided P-value of 0.05, the number of subjects required was 109 per group (total 218). The recruitment target was 120 subjects per group (total 240) to allow for dropouts.
Eligible subjects were randomized in blocks of 4 via a computer generated random number list to either the Pergoveris arm or the follitropin alpha arm.
Ovarian stimulation was performed by using GnRH antagonist protocol.
Follitropin alfa (recombinant FSH) was administered on day 2 or day 3 of the menstrual cycle. The first FSH dose was determined according to each individual patient, based on the process as follows:
- AFC ≤ 6: 300 IU/day
- AFC 7-15: 225 IU/day
- AFC ≥ 16: 150 IU/day
GnRH antagonist (Cetrotide, Merck-Serono) was administered on day 5 of FSH administration.
- Recombinant LH (in the form of Pergoveris) was supplemented from day 6 of FSH administration. Patients in the Pergoveris group would be administered a reduced dose of recombinant FSH (reduced by 150 IU/day) which was replaced with Pergoveris (150IU FSH + 75IU LH)/day.
- The Follitropin alpha group retained recombinant FSH. In both groups, if the number of developing follicles was inappropriate, the dose could be titrated depending on the physician's judgment.
Monitoring the follicular development was performed by vaginal ultrasound probe, quantifying LH, estradiol and progesterone, starting from day 5 of FSH, based on the current processes of the hospital.
OPU and embryo transfer: OPU was performed 36 hours after hCG administration. Embryos were transferred on day 2.
Luteal phase support: daily vaginal progesterone
Pregnancy testing and ultrasound: a pregnancy test was done 14 days after embryo transfer. Beta hCG > 5mIU/ml was considered positive. Fetal ultrasound was performed 3 weeks after a positive pregnancy test to verify clinical pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pergoveris (FSH and LH) | Active comparator | Drug: Pergoveris (FSH and LH)150 IU of recombinant FSH and 75 IU of recombinant LH (Pergoveris) daily subcutaneous injection |
| Follitropin alpha (FSH) | Active comparator | Drug: Follitropin alpha (FSH)150 IU of recombinant FSH (follitropin alpha or Gonal-F) daily subcutaneous injection |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- age ≥ 35 years
- body mass index <28 kg/m2
- had ≤ 3 previous IVF attempts
- receiving a GnRH-antagonist protocol
- agreement to participate in the study, and to disclose any medical events to the investigator. The subject must be willing and able to comply with the protocol requirements for the duration of the study.
Key exclusion criteria (4 listed)
- participating in another interventional clinical trial
- PCOS or WHO group 1
- have uterine abnormalities
- have endocrine disorders such as hyperprolactinemia, thyroid disorders
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 |
|---|---|---|
| Pergoveris (FSH and LH)Also: PergoverisDrugs are injected subcutaneously everyday until ovarian follicles reach 17mm in diameter. | Drug | Pergoveris (FSH and LH) |
| Follitropin alpha (FSH)Also: Gonal-FDrugs are injected subcutaneously everyday until ovarian follicles reach 17mm in diameter. | Drug | Follitropin alpha (FSH) |
Primary outcome
Clinical pregnancy
Time frame: 7 weeks after embryo transfer
Clinical pregnancy is defined by the image gestational sac under ultrasonography.
Live birth
Time frame: at the time of delivery
Live birth is defined if a live newborn delivered.
1 secondary outcome
Total FSH international units (IU) used for stimulation
Time frame: Measure at the time when stimulation finishes, eg. in average 10-11 days, maximum 20 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 25 Dec 2014.
- Derived from this study: PubMed 25740882Vuong TN, Phung HT, Ho MT. Recombinant follicle-stimulating hormone and recombinant luteinizing hormone versus recombinant follicle-stimulating hormone alone during GnRH antagonist ovarian stimulation in patients aged >/=35 years: a randomized controlled trial. Hum Reprod. 2015 May;30(5):1188-95. doi: 10.1093/humrep/dev038. Epub 2015 Mar 3.
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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.
Tuong M Ho, MD principal investigator
CGRH, School of Medicine, Vietnam National University HCMC, Vietnam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pergoveris (FSH and LH) and Follitropin alpha (FSH) in people with Infertility, run by Vietnam National University at 1 site in Vietnam.
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 6 inclusion and 4 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 25 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 Vietnam. 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?
Clinical pregnancy (time frame: 7 weeks after embryo transfer). The study lists 2 primary outcomes in all. 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 NCT02244866, 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 25 Dec 2014.