Corifollitropin Alfa Combined With Menotropin Versus Follitropin and Lutropin Alfa in Expected Suboptimal Responders (TEMPER)
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|ClinicalTrials.gov Identifier: NCT03177538|
Recruitment Status : Recruiting
First Posted : June 6, 2017
Last Update Posted : September 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Infertility, Female||Drug: Corifollitropin alfa and menotropin Drug: Follitropin alfa and lutropin alfa||Phase 4|
Patients, found eligible for the study, will be randomized (envelope method) into two arms in 1:1 ratio at the start of stimulation (menstrual cycle day 2-3, randomization day): Arm A - ovarian stimulation with Corifollitropin alfa in combination with menotropin; Arm B - ovarian stimulation with Follitropin alfa and lutropin alfa.
At the first day of controlled ovarian stimulation (COS) participants in the first group will receive a single injection of Corifollitropin alfa 150 mcg followed by daily menotropin administration at the dose of 150 international unit (IU) from stimulation day 1 to day 7 and at the dose of 300 IU from day 8 up to the end of stimulation.
Ovarian stimulation in group B will be performed with daily 300 IU of Follitropin alfa and lutropin alfa starting on menstrual cycle day 2-3.
For all subjects, a fixed dose of gonadotropin-releasing hormone (GnRH) antagonist will be injected daily as soon as one of the follicles reaches the ≥14 mm diameter and stopped one day before oocyte pick up (OPU); ovulatory dose of human chorionic gonadotropin (hCG) could be administered when at least one follicle reaches 16.5 mm in diameter.
Retrieved oocytes following fertilization (conventional IVF or ICSI) will be cultured to morula or blastocyst stage followed by ultrasound guided single or double embryo transfer (ET day, performed 4-5 days after OPU).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open Randomized Study Comparing Clinical Efficacy of Corifollitropin Alfa (Elonva) in Combination With Menotropin (Merional) With Follitropin and Lutropin Alfa (Pergoveris) for Ovarian Stimulation in Expected Suboptimal Responders|
|Actual Study Start Date :||September 4, 2017|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||September 2018|
Active Comparator: Corifollitropin alfa and menotropin
Elonva 150 mcg, Merional 150-300 IU
Drug: Corifollitropin alfa and menotropin
Procedure: Ovarian stimulation is performed by the combination of a single Corifollitropin alfa 150 mcg injection on menstrual cycle day 2-3 and daily menotropin administration at the dose of 150 IU from stimulation day 1-7 and at the dose of 300 IU from day 8 to the end of stimulation (maximal dose adjustment to 450 IU).
Other interventions: conventional GnRH antagonist protocol and in vitro fertilization (IVF/ICSI) cycle
Other Name: Elonva, Merional
Active Comparator: Follitropin alfa and lutropin alfa
Pergoveris 300 IU
Drug: Follitropin alfa and lutropin alfa
Procedure: Ovarian stimulation is performed with daily 300 IU of Follitropin alfa and lutropin alfa starting on menstrual cycle day 2-3. Maximal allowed dose adjustment is 450 IU daily.
Other interventions: conventional GnRH antagonist protocol and in vitro fertilization (IVF/ICSI) cycle.
Other Name: Pergoveris
- Number of cumulus-oocyte complexes (COCs) [ Time Frame: 3-4 weeks after ET ]Number of COCs, obtained during oocyte pick up (OPU), after controlled ovarian stimulation (COS) in two protocols
- Duration of stimulation [ Time Frame: 2-4 weeks after randomization ]total days of COS: from the first gonadotropins administration to ovulation triggering
- Number of follicles at the end of stimulation [ Time Frame: 2-4 weeks after randomization ]measured for follicles ≥17 mm and ≥14 mm
- Dose adjustment frequency [ Time Frame: 2-4 weeks after randomization ]number of participants with menopausal or recombinant human follicle stimulating hormone (FSH) dose increase
- Number of participants with optimal or suboptimal response to COS [ Time Frame: 2-4 weeks after randomization ]≥ 5 COCs at at oocyte recovery day
- Number of mature (MII) oocytes [ Time Frame: 2-4 weeks after randomization ]assessment is done only for ICSI cycles at oocyte recovery day
- Cycle cancellation rate [ Time Frame: 6-7 weeks after randomization ]number of cancelled cycles during COS (no response), at OPU (premature ovulation, absence or degradation of COCs), during in vitro cultivation (fertilization failure, inadequate embryo quality) or due to other reasons (adverse events, ovarian hyperstimulation syndrome (OHSS), withdrawal)
- Frequency of side reactions [ Time Frame: 2-4 weeks after randomization ]number of patients with local reactions (redness, itching, swelling or pain) or abdominal discomfort evaluated using visual analogue scale at the end of COS and at ET day
- Implantation rate [ Time Frame: 3-4 weeks after ET ]ratio of the number of intrauterine gestational sacs to the number of transferred embryos
- Clinical pregnancy rate [ Time Frame: 5-6 weeks after randomization ]presence of intrauterine gestational sac at transvaginal ultrasound measured per embryo transfer
- Biochemical pregnancy rate [ Time Frame: 3-4 weeks after ET ]positive ß-hCG test (≥30 IU/L) following ET without clinical pregnancy confirmation
- Fertilization rate [ Time Frame: 1 day after OPU ]number of two-pronuclear zygotes on day 1 after fertilization
- Embryo quality [ Time Frame: 3-5 days after oocyte recovery ]number of best and good quality embryos per transfer
- Cost-effectiveness of COS [ Time Frame: 6-7 weeks after randomization ]ratio of total cost of stimulation (on investigated drugs) to the number of patients with clinical pregnancy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03177538
|Contact: Alexdandr Gzgzyan, Prof, PhDfirstname.lastname@example.org|
|Contact: Valeria Muller, PhD, MDemail@example.com|
|D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology||Recruiting|
|Saint Petersburg, Russian Federation, 199034|
|Contact: Muller Valeria, PhD,MD +78123253220 firstname.lastname@example.org|
|Principal Investigator:||Alexdandr Gzgzyan, Prof, PhD||D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology|