Infertility, FemalePhase 4TEMPERNCT03177538

Corifollitropin Alfa Combined With Menotropin Versus Follitropin and Lutropin Alfa in Expected Suboptimal Responders

A Phase 4 study testing Corifollitropin alfa and menotropin and Follitropin alfa and lutropin alfa in people with Infertility, Female, run by D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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)… Read more about this study

Who is it for?: Ages 35 to 41 years, women only
Conditions the study is for: Infertility, Female
What is being tested?: Corifollitropin alfa and menotropin and Follitropin alfa and lutropin alfa
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteRussia
Study dates: 4 Sep 2017to 10 Sep 2019
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 41 years
Women only
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Russia1 site

D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology
Saint Petersburg, 199034

Other trials in Russia

About this study

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

Read the detailed 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).

Conditions: Infertility, Female
Being tested: Corifollitropin alfa and menotropin, Follitropin alfa and lutropin alfa
Keywords: suboptimal response, Corifollitropin alfa, IVF, Ovarian stimulation
Medical subject headings: Infertility, Female

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Corifollitropin alfa and menotropinDrug
Also called Elonva, Merional
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 alfaDrug
Also called Pergoveris
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.

Study groups in NCT03177538
Study group	Role	What they receive
Corifollitropin alfa and menotropin	Active comparator	Elonva 150 mcg, Merional 150-300 IU Receives: Drug: Corifollitropin alfa and menotropin
Follitropin alfa and lutropin alfa	Active comparator	Pergoveris 300 IU Receives: Drug: Follitropin alfa and lutropin alfa

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of cumulus-oocyte complexes (COCs)
Number of COCs, obtained during oocyte pick up (OPU), after controlled ovarian stimulation (COS) in two protocols
Measured: 3-4 weeks after ET

Secondary outcomes (9)

Duration of stimulation
total days of COS: from the first gonadotropins administration to ovulation triggering
Measured: 2-4 weeks after randomization
Number of follicles at the end of stimulation
measured for follicles ≥17 mm and ≥14 mm
Measured: 2-4 weeks after randomization
Dose adjustment frequency
number of participants with menopausal or recombinant human follicle stimulating hormone (FSH) dose increase
Measured: 2-4 weeks after randomization
Number of participants with optimal or suboptimal response to COS
≥ 5 COCs at at oocyte recovery day
Measured: 2-4 weeks after randomization
Number of mature (MII) oocytes
assessment is done only for ICSI cycles at oocyte recovery day
Measured: 2-4 weeks after randomization
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)
Measured: 6-7 weeks after randomization
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
Measured: 2-4 weeks after randomization
Implantation rate
ratio of the number of intrauterine gestational sacs to the number of transferred embryos
Measured: 3-4 weeks after ET
Clinical pregnancy rate
presence of intrauterine gestational sac at transvaginal ultrasound measured per embryo transfer
Measured: 5-6 weeks after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Sep 201710 Sep 2019

First posted6 Jun 2017
Study start4 Sep 2017
Primary completion2 Nov 2018
Study completion10 Sep 2019

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 Infertility, FemaleStudies 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: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03177538
Sponsor's protocol ID: 00001 (TEMPER-1)
Acronym: TEMPER
Status last verified: Sep 2019
First submitted: 23 May 2017
Last updated: 12 Sep 2019
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Ob'edkova KV, Kogan IY, Muller VC, Tapilskaya NI, Krikhely IO, Dzhemlikhanova LK, Abdulkadirova ZK, Mekina ID, Lesik EA, Komarova EA, Ishchuk MA, Gzgzian AM. IVF protocol efficacy in women with expected suboptimal response depending on ovary stimulation mode. Gynecol Endocrinol. 2021;37(sup1):44-48. doi: 10.1080/09513590.2021.2006526.
PubMed 34937512

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03177538
Acronym / sponsor ID: TEMPER / 00001 (TEMPER-1)
Conditions: Infertility, Female
Keywords: suboptimal response, Corifollitropin alfa, IVF, Ovarian stimulation
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: D.O. Ott Research Institute of Obstetrics, Gynecology, and ReproductologyUniversity, hospital or other
Study start: 4 Sep 2017 (actual)
Primary completion: 2 Nov 2018 (actual)
Study completion: 10 Sep 2019 (actual)
First posted: 6 Jun 2017 (actual)
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.

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Corifollitropin alfa and menotropin	Active comparator	Drug: Corifollitropin alfa and menotropinElonva 150 mcg, Merional 150-300 IU
Follitropin alfa and lutropin alfa	Active comparator	Drug: Follitropin alfa and lutropin alfaPergoveris 300 IU

Who may qualify

Ages: 35 to 41 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (5 listed)

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.

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 alfa and menotropinAlso: Elonva, MerionalProcedure: 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	Drug	Corifollitropin alfa and menotropin
Follitropin alfa and lutropin alfaAlso: PergoverisProcedure: 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.	Drug	Follitropin alfa and lutropin alfa

Primary outcome

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

9 secondary outcomes

Duration of stimulation
Time frame: 2-4 weeks after randomization
Number of follicles at the end of stimulation
Time frame: 2-4 weeks after randomization
Dose adjustment frequency
Time frame: 2-4 weeks after randomization
Number of participants with optimal or suboptimal response to COS
Time frame: 2-4 weeks after randomization
Number of mature (MII) oocytes
Time frame: 2-4 weeks after randomization
Cycle cancellation rate
Time frame: 6-7 weeks after randomization
Frequency of side reactions
Time frame: 2-4 weeks after randomization
Implantation rate
Time frame: 3-4 weeks after ET
Clinical pregnancy rate
Time frame: 5-6 weeks 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 12 Sep 2019.
Derived from this study: PubMed 34937512Ob'edkova KV, Kogan IY, Muller VC, Tapilskaya NI, Krikhely IO, Dzhemlikhanova LK, Abdulkadirova ZK, Mekina ID, Lesik EA, Komarova EA, Ishchuk MA, Gzgzian AM. IVF protocol efficacy in women with expected suboptimal response depending on ovary stimulation mode. Gynecol Endocrinol. 2021;37(sup1):44-48. doi: 10.1080/09513590.2021.2006526.
Individual participant dataSharing planned: No

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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.

Alexdandr Gzgzyan, Prof, PhD principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 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 12 Sep 2019. 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 Russia. 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 cumulus-oocyte complexes (COCs) (time frame: 3-4 weeks after ET). 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 NCT03177538, 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 12 Sep 2019.