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NCT Number: NCT06571214

Potential Benefit of r-hLH Addition in Patients Aged 35 to 40 Under Ovarian Stimulation Treatment

This will be an exploratory, prospective, randomized, open-label and controlled trial to evaluate the potential benefit of r-hFSH:r-hLH 2:1 co-treatment starting from COS D1 versus r-hFSH alone in patients aged 35 to 40 under ovarian stimulation treatment.

After signing informed consent form (ICF), all eligible participants will be randomly assigned in a 1:1 ratio to either treatment or control group, and GnRH antagonist protocol will be used in both treatment and control groups.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

35 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

Location contact

Haixiang Sun, Dr.

CONTACT

+8683106666

About this study

This will be an exploratory, prospective, randomized, open-label and controlled trial to evaluate the potential benefit of r-hFSH:r-hLH 2:1 co-treatment starting from COS D1 versus r-hFSH alone in patients aged 35 to 40 under ovarian stimulation treatment.

After signing informed consent form (ICF), all eligible participants will be randomly assigned in a 1:1 ratio to either treatment or control group, and GnRH antagonist protocol will be used in both treatment and control groups.

  • Treatment group: The r-hFSH starting dose will be based on the patient's profile and physician's experience. r-hLH will be added at a ratio of 2:1 starting from day 1 of r-hFSH administration; the dose of r-hFSH during COS will be adjusted by the physician based on clinical experience and the patient's ovarian response, and the r-hFSH: r-hLH dose will be 2:1, continuing to 24~48 hours prior to trigger drug injection.
  • Control group: r-hFSH alone will be administrated for ovarian stimulation. The r-hFSH starting dose will be based on the patient's profile and physician's experience. The dose of r-hFSH during COS will be adjusted by the physician based on clinical experience and the patient's ovarian response, continuing to 24~48 hours prior to trigger drug injection.

The estimated treatment duration is 11 days from the first day of COS until 24~48 h prior to trigger drug injection, and this may vary depending on individual circumstances.

Follicular development, serum E2 and P levels will be monitored during COS according to the investigator site's ART practice until the criteria to administer trigger drug are met to induce final oocyte maturation. Trigger drug administration is to be performed according to the site's routine clinical practice.

Oocyte pick-up (OPU), IVF/ICSI, ET, and luteal phase support (LPS) will be performed according to the site's routine practice. LPS will be started after oocyte retrieval in fresh embryo transfer.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 35 to 40 (including 40)
  • 18.5<BMI<28 kg/m2
  • AFC up to 14
  • First or second ART cycle
  • Planned for ovarian stimulation with GnRH-antagonist for down-regulation
  • Ejaculated sperm

Exclusion criteria

  • Contraindications to ART treatment
  • History of two or more spontaneous miscarriages
  • History of two or more implantation failures after fresh or frozen-warmed embryo transfers
  • Diagnosis of severe endometriosis
  • Patients with endocrine and metabolic diseases (diabetes mellitus, hypogonadotropic amenorrhea, genital system tumors, hyperprolactinemia, etc.)
  • Confirmed chromosomal abnormalities

Treatment and study plan

Recombinant Human Follitropin Alfa Solution for Injection (Gonal-f®)

Drug

As a r-hFSH agent, Gonal-f® is used for COS. It is a prefilled ready to use pen device containing follitropin alfa for injection and is designed for subcutaneous self-administration by patients undergoing COS for ART. It is available as dose presentations of 150 IU and 450 IU. The investigators and/or his/her delegate/s will explain the use of Gonal-f® prefilled pen. Gonal-f® will be prescribed by the investigator based on clinical diagnosis and treatment routines, and will not be provided free of charge.

Recombinant Human Lutropin alfa for Injection (r-hLH, Luveris®)

Drug

This product is a white freeze-dried powder and a colorless and clear injection solvent, and stored away from light under 25℃ in the original packaging. Luveris® will be provided free of charge.

Primary outcomes

  1. Good quality embryo rate (cleavage stage)

    Time frame: Day 3 after fertilization

    Cleavage stage good-quality embryos are defined as embryos derived from normally fertilized zygotes with 7~9 cells on day 3 post-fertilization, stage-specific cell size, less than 10% fragmentation, and no multinucleation. Cleavage stage good-quality embryo rate is defined as the number of cleavage stage good-quality embryos divided by the number of normally fertilized zygotes. Embryos will be assessed by two independent experienced embryologists to minimize intra-observation variability.

Secondary outcomes

  1. Number of oocytes

    Time frame: 24 hours after Oocytes pick up

    Number of oocytes is defined as the total number of oocytes obtained through transvaginal ultrasound guided puncture on the day of OPU. All follicles with an estimated diameter of ≥12 mm should be punctured.

  2. Number of MII oocytes (analyzed in ICSI subgroup only)

    Time frame: 24 hours after Oocytes pick up

    Number of MII oocyte is defined as the total number of an oocyte at metaphase of meiosis II, exhibiting the first polar body and with the ability to become fertilized

  3. Total r-hFSH dose

    Time frame: 24 hours after ovulation triggering

    Total r-hFSH dose is defined as the total dose of r-hFSH used for subcutaneous injection during COS period.

  4. Fertilization rate

    Time frame: 24 hours after fertilization

    • IVF normal fertilization rate is defined as the number of oocytes with 2PN and 2PB divided by the number of COCs inseminated.
    • ICSI normal fertilization rate is defined as the number of oocytes with 2PN and 2PB divided by the number of MII oocytes injected.

  5. Blastocyst development rate

    Time frame: 5 days after fertilization, up to 7 days

    Blastocyst development rate is defined as the proportion of blastocysts observed at 116 ± 2 h post-insemination as a function of the number of normally fertilized oocytes.

  6. Utilizable embryo rate

    Time frame: 5 days after fertilization, up to 7 days

    Utilizable embryo rate is defined as the number of embryos (or blastocysts) suitable for transfer or cryopreservation as a function of the number of normally fertilized (2PN) oocytes observed on Day 1.

  7. Implantation rate

    Time frame: At 4-6 weeks of amenorrhea after customized timing of embryo transfer

    Implantation rate is defined as the number of gestational sacs observed divided by the number of embryos transferred using transvaginal ultrasound 4~6 weeks after embryo transfer.

  8. Clinical pregnancy rate (per transfer cycle and per oocyte retrieval cycle)

    Time frame: At 4-6 weeks of amenorrhea after customized timing of embryo transfer

    Clinical pregnancy rate is defined as the number of clinical pregnancies expressed per 100 initiated cycles, aspiration cycles, or embryo transfer cycles. Clinical pregnancy is defined as the presence of gestational sac (intrauterine or ectopic) using ultrasound examination at 4~6 weeks after embryo transfer.

  9. Ongoing pregnancy rate

    Time frame: At 12 weeks of amenorrhea after customized timing of embryo transfer

    Ongoing pregnancy rate is defined as the number of intrauterine pregnancies continued for 12 gestational weeks divided by the number of embryo transfer cycles.

  10. Ovarian sensitivity index (OSI)

    Time frame: 24 hours after fertilization

    OSI is defined as the total r-hFSH dose divided by the number of oocytes retrieved.

  11. Follicular output rate (FORT)

    Time frame: 24 hours after fertilization

    FORT is defined as the number of pre-ovulatory follicles (16~22 mm) on the day of trigger divided by the AFC (3~8 mm)

  12. Follicle oocyte index (FOI)

    Time frame: 24 hours after fertilization

    FOI is defined as the number of total oocytes retrieved divided by the AFC

  13. Safety Assessments

    Time frame: During the COS cycle (average cycle range 11 days), Up to 12 weeks after transfer

    AE, SAE and OHSS

Study contacts

Contact information is provided by the study sponsor or research team.

Haixiang Sun, Dr.

CONTACT

[email protected]

13851622008

Sponsors and collaborators

Lead sponsor

Nanjing University

Other

Registry information

Official study title

An Exploratory, Randomized, Open-label, Controlled Study to Evaluate the Potential Benefit of r-hLH Addition in Patients Aged 35 to 40 Under Ovarian Stimulation Treatment

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 26, 2024
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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