InfertilityPhase 4NCT02466204
Efficacy of Corifollitropin Alfa Versus Follitropin Beta in Aged IVF (In-vitro Fertilization) Patients
A Phase 4 study testing corifollitropin alfa and Follitropin Beta in people with Infertility, run by Vietnam National University at 2 sites in Vietnam.
Trial summary
A prospective, randomized, controlled study to explore the efficacy and safety of using either corifollitropin alfa 150 mcg or daily recombinant follicle stimulation hormone (FSH) 300 international unit (IU) for the stimulation treatment of subjects undergoing controlled ovarian stimulation prior to IVF. Read more about this study
- Who is it for?
- Ages 35 to 42 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- corifollitropin alfa and Follitropin Beta
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesVietnam
- Study dates
- 1 Jun 2015to 15 Aug 2017
- Phase
- Phase 4
- 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 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Each subject must be willing and able to provide written informed consent for the study.
- Each subject must be female with years of age ≥35 to ≤42 at the time of recruitment..
- Each subject must have an indication for controlled ovarian stimulation and IVF
- Each subject must have a body weight ≥ 50.0 kg, with a body mass index (BMI) ≥18.0 to ≤32.0 kg/m2.
- Each subject must have a regular spontaneous menstrual cycle with an intra-individual variation not outside the 24 to 35 days range.
- For each subject, ejaculatory sperm must be available (use of donated and/or cryopreserved sperm is allowed; sperm obtained via surgical sperm retrieval is not allowed).
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- Each subject must have results of clinical laboratory test (complete blood count, blood chemistries, and urinalysis) within normal limits or clinically acceptable to the investigator, as measured by the local laboratory at screening. A normal cervical smear result, obtained within 12 months, otherwise it must be obtained during screening.
- Each subject must have results of a physical examination, including blood pressure, within normal limits or clinically acceptable limits to the investigator.
- Each subject must have normal ovarian reserve, based on anti-Mullerian hormon (AMH) of 1.38 - 3.25ng/ml or an antral follicle count (AFC) of 7-20, taken within 2 months prior to corifollitropin alfa start.
- Each subject must be able to adhere to dose and visit schedules and willing to disclose any medical events to the investigator.
Who cannot join
- The subject has a recent (ie, within 3 years) history of/ or any current endocrine abnormality (irrespective whether the patient is stabilized on treatment).
- The subject has a history of ovarian hyper-response (ie, previous IVF cycle with more than 30 follicles ≥11 mm on ultrasound) or ovarian hyperstimulation syndrome (OHSS).
- The subject has a history of/or current polycystic ovary syndrome (PCOS)
- The subject has more 20 basal antral follicles <11 mm (both ovaries combined) as measured on ultrasound in the early follicle phase (menstrual cycle day 2-5).
- The subject has less than 2 ovaries in any other ovarian abnormality (including endometrioma > 10 mm; visible on ultrasound).
- The subject has unilateral or bilateral hydrosalpinx (visible on ultrasound, less clipped).
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- The subject has any intra-uterine fibroids >5 cm or any clinically relevant pathology, which could impair embryo implantation or pregnancy continuation.
- The subject has more than three unsuccessful treatment cycles for IVF/ICSI.
- The subject has a history of non- or low avarian response to FSH / Human Menopausal Gonadotropin (hMG) treatment (ie, previous COS cycle cancelled due to insufficient ovarian response or ≤3 oocytes obtained).
- The subject has a history of current miscarriage (3 or more, even when explained).
- The subject has FSH > 15.0 IU/L or LH > 12 .0 IU/L as measured by the local laboratory (sample taken during the early follicle phase: menstrual cycle day 2 to 5).
- The subject has tested positive for human immunodeficiency virus (HIV) or Hepatitis B (results obtained within one year) .
- The subject has contra-indications for the use of gonadotropins (eg, tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, or ovarian cysts) or GnRH antagonist (eg, hypersensitivity, pregnancy/lactation).
- The subject has a concomitant use of either LH or hMG/urinary FSH preparations in study cycle.
- The subject has a recent history of/or current epilepsy, thrombophilia, diabetes, cardiovascular, gastro-intestinal, hepatic, renal or pulmonary or auto-immune disease requiring regular treatment.
- The subject or the sperm donor has known gene defects, genetic abnormalities, or abnormal karyotyping, relevant for the current indications or for the health of the offspring.
- The subject smokes or has recently stopped smoking (ie, within the last 3 months prior to signing ICF).
- The subject has a history or presence of alcohol or drug abuse within 12 months prior to signing informed consent.
- The subject has an allergy/ sensitivity to investigational drugs or their excipients.
- The subject has used any experimental drugs within 3 months prior to signing informed consent.
- The subject is participating in any other clinical study (excluding surveys).
Trial locations and contacts
2 sites in 1 country.
Vietnam2 sites
My Duc Hospital
Ho Chi Minh City, 70000
Research Center for Genetics and Reproductive Health
Ho Chi Minh City, 70000
About this study
Official title: An Efficacy and Safety Study of Corifollitropin Alfa Versus Daily Follitropin Beta for Controlled Ovarian Stimulation in Women 35-42 Years Old With a Body Weight ≥ 50 kg Undergoing IVF Treatment.
A prospective, randomized, controlled study to explore the efficacy and safety of using either corifollitropin alfa 150 mcg or daily recombinant follicle stimulation hormone (FSH) 300 international unit (IU) for the stimulation treatment of subjects undergoing controlled ovarian stimulation prior to IVF.
The study is designed as a non-inferiority trial. The sample size for this trial of 400 subjects, in both groups, being treated for one IVF cycle is based upon the primary endpoint of the number of oocytes retrieved.
Read the detailed description
Stimulation regimen and assisted reproductive technology procedures
Corifollitropin Alfa Group: On day 2 or day 3 of the menstrual cycle, a single subcutaneous injection of corifollitropin alfa 150 mg/ 0.5 mL is administered (stimulation day 1).
FSH Group: Daily subcutaneous injections with recombinant FSH (Follitropin Beta) 300 international units (IU) is started on On day 2 or day 3 of the menstrual cycle (stimulation day 1) and continue up to and including stimulation day 7.
From stimulation day 8 onwards, subjects from both treatment groups will continue with a daily subcutaneous dose of FSH up to the day before human chorionic gonadotropin (hCG) administration or gonadotropin releasing hormone agonist administration day. The maximum FSH dose to continue treatment after the first 7 days is 300 IU, but the dose could be reduced when desired.
To prevent premature luteinizing hormone (LH) surges the gonadotropin releasing hormone (GnRH) antagonist (ganirelix acetate subcutaneous injection, 0.25 mg/ 0.5 mL) is administered, starting on stimulation day 5.
As soon as at least three follicles of 17 mm are observed by ultrasound, hCG or a GnRH agonist will be used for final oocyte maturation at the same day. hCG is used if 3-18 follicles and 0.2 mg triptorelin is administered if ≥ 19 follicles >11 mm are observed. About 34-36 hours thereafter, oocyte retrieval followed by IVF or intra-cytoplasmic sperm injection (ICSI) is performed. Three days after oocyte pick-up, 2 to 3 fresh embryos will be transferred. If patients have high progesterone level on day of trigger (progesterone level > 1,5 ng/ml), risk of OHSS and unfavorable endometrium, fresh transfers will be cancelled and freeze all will be recommended.
Patients using hCG for final oocyte maturation will receive luteal phase support with progestogen gel (90 mg once daily) intra-vaginally and estradiol (4 mg/day orally, twice daily) initiated on the day of oocyte retrieval or the day thereafter. Patients, using GnRH agonist for triggering, will have fresh transfer with intense luteal phase support of estradiol and progesterone (receive intense luteal phase support with estradiol and progesterone as the same dose mentioned above and progesterone 50 mg intramuscular injection per day).
Assessments
Patients will return to the clinic for pregnancy test 2 weeks after embryo transfers.
Local tolerance parameters (pain, itching, swelling and redness) are assessed by the clinical staff 30 min after injection for both corifollitropin alfa and FSH injection sites.
Clinical Outcome The primary objective is to show that the corifollitropin alfa regimen, in terms of the number of oocytes retrieved, is equivalent to the reference treatment (predefined equivalence range: -3 to +5 oocytes).
Other clinical parameters will also be evaluated: dose of FSH required, duration of stimulation, number and size of follicles (≥11mm and ≥14 mm), serum hormone levels, fertilization rate, number and quality of embryos obtained, implantation rate, miscarriage rate, and pregnancy rates.
At least 14 days after embryo transfer, a blood pregnancy test is performed. If the pregnancy test is positive, vaginal and/or abdominal ultrasonographic investigation is performed between 35 and 42 days ( 5 to 6 weeks) after embryo transfer to confirm a clinical pregnancy and at least 70 days (≥ 10 weeks) after embryo transfer to confirm an ongoing pregnancy.
Patients will be followed to one year after randomization.
All efficacy analyses will be based on the intent-to-treat (ITT) population, which included all randomized patients who will receive corifollitropin alfa or at least one dose of FSH
Safety endpoints
Occurrence of adverse events, including moderate and severe ovarian hyperstimulation syndrome (OHSS), outcome of local tolerance at injection site assessments will be evaluated as safety endpoints.
The percentage of patients with moderate or severe OHSS and local tolerance is compared between the treatment groups using Fisher's exact test.
Safety analyses will be performed on the all-subjects-treated group, which comprised all the patients who will receive either corifollitropin alfa or FSH.
- Conditions
- Infertility
- Being tested
- corifollitropin alfa, Follitropin Beta
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
corifollitropin alfaDrug
Also called Elonva
Drug is injected subcutaneously. Seven days after, 300 IU FSH daily injected subcutaneously, until at least two leading ovarian follicles reach 17mm in diameter.
Follitropin BetaDrug
Also called Puregon
Drug is injected subcutaneously, daily, until at least two leading ovarian follicles reach 17mm in diameter.
| Study group | Role | What they receive |
|---|---|---|
| corifollitropin alfa (long action FSH) | Active comparator | corifollitropin alfa 150 mcg subcutaneous injection. Seven days after, combines with recombinant FSH 300 IU daily subcutaneous injection Receives: Drug: corifollitropin alfa |
| Follitropin Beta (recombinant FSH) | Active comparator | 300 IU of recombinant FSH, daily subcutaneous injection Receives: Drug: Follitropin Beta |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of oocytes
in 10 minutes after oocyte retrieval, total number of oocytes retrieved is counted and recorded
Measured: 10 minutes after oocyte retrieval completed
Secondary outcomes (20)
Rate of moderate and severe ovarian hyperstimulation syndrome
symptoms of ovarian hyperstimulation syndrome are followed and recorded until 8 days after oocyte retrieval.
Measured: 8 days after oocyte retrieval
Live birth
delivery of live birth
Measured: at the time of delivery
number of MII oocytes
Number of mature oocytes collected
Measured: 2 hours after oocyte retrieval completed
number of 2PN
number of two pronuclear (2PN) fertilized oocytes
Measured: 18 hours after sperm injection
number of mature follicles >11 mm
number of mature follicles >11 mm in diameter
Measured: on the day of hCG administration
estradiol level
serum level of estradiol
Measured: on the day of hCG administration
FSH dose
total dose of FSH
Measured: calculated on the day of hCG administration
implantation rate
number of sacs with heart beat per total number of embryos transferred
Measured: 5 to 6 weeks after embryo transfer
Clinical pregnancy
gestational sac on ultrasound
Measured: at 5 to 6 six weeks after embryo transfer
Ectopic pregnancy
The presence of a gestational sac outside the uterine cavity shown on sonography or laparoscopy
Measured: 7 to 8 weeks after embryo transfer
Miscarriage
Loss of clinical pregnancy
Measured: 7 to 12 weeks of gestation
Multiple pregnancy
more than one gestational sacs or heart beats on ultrasound
Measured: at 7 weeks of gestation
Ongoing pregnancy
At least one gestational sac on ultrasound
Measured: at 10 weeks after embryo transfer
Cumulative ongoing pregnancy
Cumulative ongoing pregnancy at 12 months after randomization
Measured: at 12 months after randomization
Pregnancy-induced hypertension
systolic blood pressure ≥140 mmHg or diastolic pressure ≥90 mmHg on two occasions, two hours apart, or severely elevated single blood pressure measurement requiring antihypertensive medication
Measured: measured at or after 20 weeks gestation
Pre-eclampsia
hypertension plus proteinuria or other organ involvement, neurologic or hematologic complications, uteroplacental dysfunction, or fetal growth restriction
Measured: measured at or after 20 weeks gestation
HELLP syndrome
Elevated liver enzyme levels (aspartate aminotransferase ≥100 U/L), thrombocytopenia (platelet count <100,000/mm3), elevated serum creatinine level (≥1.5 mg/dL [132.6 μmol/L]) and/or hemolysis (hemoglobin <10 g/dL)
Measured: measured at or after 20 weeks gestation
Gestational diabetes mellitus
Diagnosed using a 75g oral glucose tolerance test; fasting: 92 mg/dL [5.1 mmol/L]; 2-hour: 153 mg/dL [8.5 mmol/L]
Measured: measured at or after 20 weeks gestation
Prematurity
preterm birth if any
Measured: at 24 weeks gestation, at 32 weeks gestation, at 34 weeks gestation, and at 37 weeks' gestation
Cumulative live birth
cumulative live birth delivery at 12 months after randomization
Measured: at 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study start1 Jun 2015
- Primary completion10 Aug 2016
- Study completion15 Aug 2017
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vietnam National University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Mỹ Đức Hospital
- Responsible party
- Principal investigator, Manh Tuong Ho, Vietnam National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02466204
- Sponsor's protocol ID
- NCKH/CGRH_ 01_2015
- Status last verified
- Aug 2017
- First submitted
- 2 Jun 2015
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Vuong NL, Pham DT, Phung HT, Giang HN, Huynh GB, Nguyen TTL, Ho MT. Corifollitropin alfa vs recombinant FSH for controlled ovarian stimulation in women aged 35-42 years with a body weight >/=50 kg: a randomized controlled trial. Hum Reprod Open. 2017 Nov 28;2017(3):hox023. doi: 10.1093/hropen/hox023. eCollection 2017.
PubMed 30895237
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Efficacy and Safety Study of Corifollitropin Alfa Versus Daily Follitropin Beta for Controlled Ovarian Stimulation in Women 35-42 Years Old With a Body Weight ≥ 50 kg Undergoing IVF Treatment.
- ClinicalTrials.gov ID
- NCT02466204
- Acronym / sponsor ID
- NCKH/CGRH_ 01_2015
- Conditions
- Infertility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Vietnam National UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Mỹ Đức Hospital
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 10 Aug 2016 (actual)
- Study completion
- 15 Aug 2017 (actual)
- First posted
- 9 Jun 2015 (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.
A prospective, randomized, controlled study to explore the efficacy and safety of using either corifollitropin alfa 150 mcg or daily recombinant follicle stimulation hormone (FSH) 300 international unit (IU) for the stimulation treatment of subjects undergoing controlled ovarian stimulation prior to IVF.
The study is designed as a non-inferiority trial. The sample size for this trial of 400 subjects, in both groups, being treated for one IVF cycle is based upon the primary endpoint of the number of oocytes retrieved.
Detailed description
Stimulation regimen and assisted reproductive technology procedures
Corifollitropin Alfa Group: On day 2 or day 3 of the menstrual cycle, a single subcutaneous injection of corifollitropin alfa 150 mg/ 0.5 mL is administered (stimulation day 1).
FSH Group: Daily subcutaneous injections with recombinant FSH (Follitropin Beta) 300 international units (IU) is started on On day 2 or day 3 of the menstrual cycle (stimulation day 1) and continue up to and including stimulation day 7.
From stimulation day 8 onwards, subjects from both treatment groups will continue with a daily subcutaneous dose of FSH up to the day before human chorionic gonadotropin (hCG) administration or gonadotropin releasing hormone agonist administration day. The maximum FSH dose to continue treatment after the first 7 days is 300 IU, but the dose could be reduced when desired.
To prevent premature luteinizing hormone (LH) surges the gonadotropin releasing hormone (GnRH) antagonist (ganirelix acetate subcutaneous injection, 0.25 mg/ 0.5 mL) is administered, starting on stimulation day 5.
As soon as at least three follicles of 17 mm are observed by ultrasound, hCG or a GnRH agonist will be used for final oocyte maturation at the same day. hCG is used if 3-18 follicles and 0.2 mg triptorelin is administered if ≥ 19 follicles >11 mm are observed. About 34-36 hours thereafter, oocyte retrieval followed by IVF or intra-cytoplasmic sperm injection (ICSI) is performed. Three days after oocyte pick-up, 2 to 3 fresh embryos will be transferred. If patients have high progesterone level on day of trigger (progesterone level > 1,5 ng/ml), risk of OHSS and unfavorable endometrium, fresh transfers will be cancelled and freeze all will be recommended.
Patients using hCG for final oocyte maturation will receive luteal phase support with progestogen gel (90 mg once daily) intra-vaginally and estradiol (4 mg/day orally, twice daily) initiated on the day of oocyte retrieval or the day thereafter. Patients, using GnRH agonist for triggering, will have fresh transfer with intense luteal phase support of estradiol and progesterone (receive intense luteal phase support with estradiol and progesterone as the same dose mentioned above and progesterone 50 mg intramuscular injection per day).
Assessments
Patients will return to the clinic for pregnancy test 2 weeks after embryo transfers.
Local tolerance parameters (pain, itching, swelling and redness) are assessed by the clinical staff 30 min after injection for both corifollitropin alfa and FSH injection sites.
Clinical Outcome The primary objective is to show that the corifollitropin alfa regimen, in terms of the number of oocytes retrieved, is equivalent to the reference treatment (predefined equivalence range: -3 to +5 oocytes).
Other clinical parameters will also be evaluated: dose of FSH required, duration of stimulation, number and size of follicles (≥11mm and ≥14 mm), serum hormone levels, fertilization rate, number and quality of embryos obtained, implantation rate, miscarriage rate, and pregnancy rates.
At least 14 days after embryo transfer, a blood pregnancy test is performed. If the pregnancy test is positive, vaginal and/or abdominal ultrasonographic investigation is performed between 35 and 42 days ( 5 to 6 weeks) after embryo transfer to confirm a clinical pregnancy and at least 70 days (≥ 10 weeks) after embryo transfer to confirm an ongoing pregnancy.
Patients will be followed to one year after randomization.
All efficacy analyses will be based on the intent-to-treat (ITT) population, which included all randomized patients who will receive corifollitropin alfa or at least one dose of FSH
Safety endpoints
Occurrence of adverse events, including moderate and severe ovarian hyperstimulation syndrome (OHSS), outcome of local tolerance at injection site assessments will be evaluated as safety endpoints.
The percentage of patients with moderate or severe OHSS and local tolerance is compared between the treatment groups using Fisher's exact test.
Safety analyses will be performed on the all-subjects-treated group, which comprised all the patients who will receive either corifollitropin alfa or FSH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| corifollitropin alfa (long action FSH) | Active comparator | Drug: corifollitropin alfacorifollitropin alfa 150 mcg subcutaneous injection. Seven days after, combines with recombinant FSH 300 IU daily subcutaneous injection |
| Follitropin Beta (recombinant FSH) | Active comparator | Drug: Follitropin Beta300 IU of recombinant FSH, daily subcutaneous injection |
Who may qualify
- Ages
- 35 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Each subject must be willing and able to provide written informed consent for the study.
- Each subject must be female with years of age ≥35 to ≤42 at the time of recruitment..
- Each subject must have an indication for controlled ovarian stimulation and IVF
- Each subject must have a body weight ≥ 50.0 kg, with a body mass index (BMI) ≥18.0 to ≤32.0 kg/m2.
- Each subject must have a regular spontaneous menstrual cycle with an intra-individual variation not outside the 24 to 35 days range.
Key exclusion criteria (21 listed)
- The subject has a recent (ie, within 3 years) history of/ or any current endocrine abnormality (irrespective whether the patient is stabilized on treatment).
- The subject has a history of ovarian hyper-response (ie, previous IVF cycle with more than 30 follicles ≥11 mm on ultrasound) or ovarian hyperstimulation syndrome (OHSS).
- The subject has a history of/or current polycystic ovary syndrome (PCOS)
- The subject has more 20 basal antral follicles <11 mm (both ovaries combined) as measured on ultrasound in the early follicle phase (menstrual cycle day 2-5).
- The subject has less than 2 ovaries in any other ovarian abnormality (including endometrioma > 10 mm; visible on ultrasound).
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 |
|---|---|---|
| corifollitropin alfaAlso: ElonvaDrug is injected subcutaneously. Seven days after, 300 IU FSH daily injected subcutaneously, until at least two leading ovarian follicles reach 17mm in diameter. | Drug | corifollitropin alfa (long action FSH) |
| Follitropin BetaAlso: PuregonDrug is injected subcutaneously, daily, until at least two leading ovarian follicles reach 17mm in diameter. | Drug | Follitropin Beta (recombinant FSH) |
Primary outcome
number of oocytes
Time frame: 10 minutes after oocyte retrieval completed
in 10 minutes after oocyte retrieval, total number of oocytes retrieved is counted and recorded
20 secondary outcomes
Rate of moderate and severe ovarian hyperstimulation syndrome
Time frame: 8 days after oocyte retrieval
Live birth
Time frame: at the time of delivery
number of MII oocytes
Time frame: 2 hours after oocyte retrieval completed
number of 2PN
Time frame: 18 hours after sperm injection
number of mature follicles >11 mm
Time frame: on the day of hCG administration
estradiol level
Time frame: on the day of hCG administration
FSH dose
Time frame: calculated on the day of hCG administration
implantation rate
Time frame: 5 to 6 weeks after embryo transfer
Clinical pregnancy
Time frame: at 5 to 6 six weeks after embryo transfer
Ectopic pregnancy
Time frame: 7 to 8 weeks after embryo transfer
Miscarriage
Time frame: 7 to 12 weeks of gestation
Multiple pregnancy
Time frame: at 7 weeks of gestation
Ongoing pregnancy
Time frame: at 10 weeks after embryo transfer
Cumulative ongoing pregnancy
Time frame: at 12 months after randomization
Pregnancy-induced hypertension
Time frame: measured at or after 20 weeks gestation
Pre-eclampsia
Time frame: measured at or after 20 weeks gestation
HELLP syndrome
Time frame: measured at or after 20 weeks gestation
Gestational diabetes mellitus
Time frame: measured at or after 20 weeks gestation
Prematurity
Time frame: at 24 weeks gestation, at 32 weeks gestation, at 34 weeks gestation, and at 37 weeks' gestation
Cumulative live birth
Time frame: at 12 months after randomization
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 22 Aug 2017.
- Derived from this study: PubMed 30895237Vuong NL, Pham DT, Phung HT, Giang HN, Huynh GB, Nguyen TTL, Ho MT. Corifollitropin alfa vs recombinant FSH for controlled ovarian stimulation in women aged 35-42 years with a body weight >/=50 kg: a randomized controlled trial. Hum Reprod Open. 2017 Nov 28;2017(3):hox023. doi: 10.1093/hropen/hox023. eCollection 2017.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing corifollitropin alfa and Follitropin Beta in people with Infertility, run by Vietnam National University at 2 sites 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 10 inclusion and 21 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 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 oocytes (time frame: 10 minutes after oocyte retrieval completed). 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 NCT02466204, 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 22 Aug 2017.