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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03177538
Other study ID # 00001 (TEMPER-1)
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 4, 2017
Est. completion date September 10, 2019

Study information

Verified date September 2019
Source D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In an opened randomized study of women undergoing in vitro fertilization with expected suboptimal response to controlled ovarian stimulation (Poseidon Group 2b) investigators will examine clinical efficacy and safety of two stimulation protocols: Corifollitropin alfa (Elonva) in combination with menotropin (Merional) versus Follitropin alfa and lutropin alfa (Pergoveris).


Description:

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).


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date September 10, 2019
Est. primary completion date November 2, 2018
Accepts healthy volunteers No
Gender Female
Age group 35 Years to 41 Years
Eligibility Inclusion Criteria:

- Female age between 35-41 years;

- BMI 17,5-30 kg/m2;

- Expected suboptimal responders (according to Poseidon classification, 2016, Group 2b): patients with suboptimal ovarian reserve prestimulation parameters in terms of antimüllerian hormone (AMH) and antral follicle count (AFC): AFC 5-9, AMH =0.8 ng/mL;

- Early follicular phase follicle stimulating hormone (FSH) =15 IU/L;

- Presence of viable spermatozoa in partner's sperm;

- Signed informed consent.

Exclusion Criteria:

- Pre-existing medical condition preventing or interfering with IVF treatment: any clinically significant systemic disease; inherited or acquires thrombophilia and thromboembolism; endocrine or metabolic abnormalities; moderate or severe impairment of renal or hepatic function; any oncological diseases in anamnesis; known history of recurrent miscarriage, abnormal karyotype of both partners; currently active pelvic inflammatory disease;

- Abnormal IVF screening tests: Papanicolaou test, Syphilis, HIV 1&2, Hepatitis B, Hepatitis C, Chlamydia, and Gonorrhea;

- Presence of uterine pathology: Asherman's Syndrome, endometrial polyps, nodus form of adenomyosis or uterine fibroids =3 mm in diameter;

- Visualization of ovarian cysts =25 mm, endometriomas or hydrosalpinx;

- One or more follicles =8 mm on randomization day.

Study Design


Related Conditions & MeSH terms


Intervention

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
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.

Locations

Country Name City State
Russian Federation D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology Saint Petersburg

Sponsors (1)

Lead Sponsor Collaborator
D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Other Biochemical pregnancy rate positive ß-hCG test (=30 IU/L) following ET without clinical pregnancy confirmation 3-4 weeks after ET
Other Fertilization rate number of two-pronuclear zygotes on day 1 after fertilization 1 day after OPU
Other Embryo quality number of best and good quality embryos per transfer 3-5 days after oocyte recovery
Other Cost-effectiveness of COS ratio of total cost of stimulation (on investigated drugs) to the number of patients with clinical pregnancy 6-7 weeks after randomization
Primary Number of cumulus-oocyte complexes (COCs) Number of COCs, obtained during oocyte pick up (OPU), after controlled ovarian stimulation (COS) in two protocols 3-4 weeks after ET
Secondary Duration of stimulation total days of COS: from the first gonadotropins administration to ovulation triggering 2-4 weeks after randomization
Secondary Number of follicles at the end of stimulation measured for follicles =17 mm and =14 mm 2-4 weeks after randomization
Secondary Dose adjustment frequency number of participants with menopausal or recombinant human follicle stimulating hormone (FSH) dose increase 2-4 weeks after randomization
Secondary Number of participants with optimal or suboptimal response to COS = 5 COCs at at oocyte recovery day 2-4 weeks after randomization
Secondary Number of mature (MII) oocytes assessment is done only for ICSI cycles at oocyte recovery day 2-4 weeks after randomization
Secondary Cycle cancellation rate 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) 6-7 weeks after randomization
Secondary Frequency of side reactions 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 2-4 weeks after randomization
Secondary Implantation rate ratio of the number of intrauterine gestational sacs to the number of transferred embryos 3-4 weeks after ET
Secondary Clinical pregnancy rate presence of intrauterine gestational sac at transvaginal ultrasound measured per embryo transfer 5-6 weeks after randomization
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