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

NCT03177538 | Completed Phase 4

• 1 other identifier: 00001 (TEMPER-1)
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Infertility, Female

Keywords

suboptimal response; Corifollitropin alfa; IVF; Ovarian stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Duration of stimulation

  2-4 weeks after randomization

• Number of follicles at the end of stimulation

  2-4 weeks after randomization

• Dose adjustment frequency

  2-4 weeks after randomization

• Number of participants with optimal or suboptimal response to COS

  2-4 weeks after randomization

• Number of mature (MII) oocytes

  2-4 weeks after randomization

Other Outcomes (4)

• Biochemical pregnancy rate

  3-4 weeks after ET

• Fertilization rate

  1 day after OPU

• Embryo quality

  3-5 days after oocyte recovery

Study Arms (2)

Corifollitropin alfa and menotropin

ACTIVE COMPARATOR

Elonva 150 mcg, Merional 150-300 IU

Drug: Corifollitropin alfa and menotropin

Follitropin alfa and lutropin alfa

ACTIVE COMPARATOR

Pergoveris 300 IU

Drug: Follitropin alfa and lutropin alfa

Interventions

Corifollitropin alfa and menotropin DRUG

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

Also known as: Elonva, Merional

Corifollitropin alfa and menotropin

Follitropin alfa and lutropin alfa DRUG

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.

Also known as: Pergoveris

Follitropin alfa and lutropin alfa

Eligibility Criteria

• Age: 35 Years - 41 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

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

Saint Petersburg, 199034, Russia

Location

Related Publications (1)

• 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.

  PMID: 34937512 DERIVED

MeSH Terms

Conditions

Infertility, Female

Interventions

follicle stimulating hormone, human, with HCG C-terminal peptide; Menotropins; hMG-IBSA; follitropin alfa; Luteinizing Hormone, beta Subunit; pergoveris

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Gonadotropins, Pituitary; Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Peptides; Amino Acids, Peptides, and Proteins; Biological Products; Complex Mixtures; Luteinizing Hormone

Study Officials

• Alexdandr Gzgzyan, Prof, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MD

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: June 6, 2017
• Study Start: September 4, 2017
• Primary Completion: November 2, 2018
• Study Completion: September 10, 2019
• Last Updated: September 12, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)