Infertility Clinical Trial
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03607409 -
Role of Inhibin A as Biomarker for Ovarian Response for IVF Treatment
|
||
Recruiting |
NCT02312076 -
GnRHa for Luteal Phase Support in Long GnRHa Protocol Cycles
|
Phase 4 | |
Terminated |
NCT02161861 -
Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study
|
N/A | |
Completed |
NCT03287479 -
Comparison of a Semi-automated Closed Vitrification System (Gavi®) With a Manual Open Vitrification Sytem (Cryotop®)
|
N/A | |
Terminated |
NCT03522350 -
Randomized Trial Comparing EmbryoScope With EmbryoScope+.
|
N/A | |
Completed |
NCT04496284 -
Embryo Transfer Outcomes After Vitrification With Slush Nitrogen Compared to Liquid Nitrogen
|
N/A | |
Completed |
NCT03623659 -
pArtiaL zonA pelluciDa Removal by assisteD hatchINg of Blastocysts
|
N/A | |
Completed |
NCT03895099 -
New Ovarian Stimulation With Random Start, Use of Progestin Protocol for Oocyte Donors
|
Phase 3 | |
Active, not recruiting |
NCT04142112 -
Randomized, Standard-Controlled, Study to Evaluate the Ohana IVF Sperm Preparation Kit, SPeRtility IVF Next Generation
|
N/A | |
Completed |
NCT03152643 -
Cumulative Live Birth Rates After Cleavage-stage Versus Blastocyst-stage Embryo Transfer
|
N/A | |
Recruiting |
NCT03683771 -
Assessment of Endometrial Pattern and Sub-endometrial Vascularity in ICSI Outcome
|
||
Recruiting |
NCT03161119 -
Comparing Two Different Embryo Transfer Catheters
|
N/A | |
Completed |
NCT04108039 -
Micronized Progesterone vs Gonadotropin-releasing Hormone (GnRH) Antagonist in Freeze-all IVF Cycles.
|
N/A | |
Completed |
NCT03678584 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Chaetoglobosin A ( ICSI-CA)
|
N/A | |
Completed |
NCT03678818 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin A (ICSI-LA)
|
N/A | |
Completed |
NCT03678558 -
Oocyte Vitrification Aided With Cytochalasin B
|
N/A | |
Completed |
NCT03678597 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin B ( ICSI-LB)
|
N/A | |
Completed |
NCT03677492 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Cytochalasin D ( ICSI-CD)
|
N/A | |
Completed |
NCT03678571 -
Oocyte Vitrification Aided With Latrunculin A
|
N/A | |
Completed |
NCT03678610 -
Handling Medium for ICSI With Ionomycin and Latrunculin A
|
N/A |